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    Clinical Trial Results:
    Do oral corticosteroids provide clinical and cost-effective symptom relief for sore throat? A multi-centre, double blind, randomized, placebo-controlled trial.

    Summary
    EudraCT number
    		 2012-004330-41
    Trial protocol
    		 GB  
    Global end of trial date
    16 Apr 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 May 2016
    First version publication date
    01 May 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CH-GH/TOAST/0006
    Additional study identifiers
    ISRCTN number
    		 ISRCTN17435450
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Oxford
    Sponsor organisation address
    Block 60, Churchill Hospital, Oxford, United Kingdom, OX3 7LJ
    Public contact
    Professor Carl Heneghan, Nuffield Department of Primary Care Health Sciences, University of Oxford, carl.heneghan@phc.ox.ac.uk
    Scientific contact
    Professor Carl Heneghan, Nuffield Department of Primary Care Health Sciences, University of Oxford, carl.heneghan@phc.ox.ac.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 May 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Apr 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Apr 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate in adults 18 years and over presenting to their GP with acute sore throat, if the use of a single dose of an oral steroid, dexamethasone, compared with no steroid treatment leads to increased resolution or improvement in symptoms.
    Protection of trial subjects
    The DSMC were conducted to review of all SAEs for the study reported during the quarter and cumulatively. No formal interim analysis is planned to stop the trial early. Dexamethasone is already licenced and used at this dosage in a wide variety of disorders as well as in the control of cerebral oedema. Previous trials have not reported any serious adverse events nor differences in all adverse events, relapse or recurrence rates between participants receiving corticosteroids and those receiving placebo, hence it is anticipated that the likelihood of serious adverse events (SAEs) associated with a single dose of dexamethasone 10mg taken orally will be extremely low. There is therefore no defined criteria for termination of the trial due to safety however serious adverse events and events leading to withdrawal will be reviewed in order to monitor anything unexpected.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Feb 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 576
    Worldwide total number of subjects
    576
    EEA total number of subjects
    576
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    546
    From 65 to 84 years
    26
    85 years and over
    4

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The first participant was recruited on 12th April 2013 and the final participant on 27th February 2015. Participants were recruited from general practices in Oxford, Bristol, and Southampton in England, UK. The site gives adults presenting with sore throat a participant information sheet which details what is involved in trial participation.

    Pre-assignment
    Screening details
    		 During the initial consultation the primary care clinician (referred to from now onwards as the responsible clinician) discusses trial participation and screens the participant using the inclusion and exclusion criteria.

    Period 1
    Period 1 title
    Overall trial
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Matching placebo and use of pack numbers. The pack numbers are produced by an independent statistician who was not involved in any other aspect of the trial.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dexamethasone
    Arm description
    		 10mg oral dexamethasone
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    5 x 2mg tablets were over-encapsulated into one capsule and was administered orally as single dose.

    Arm title
    		 Placebo
    Arm description
    		 Placebo - Single capsule using lactose
    Arm type
    		 Placebo

    Investigational medicinal product name
    PR1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Matching size 1 capsule using lactose. Administered orally as the IMP

    Number of subjects in period 1
    		Dexamethasone Placebo
    Started
    293
    283
    Completed
    293
    283
    Period 2
    Period 2 title
    Subgroup - No antibiotic prescription
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dexamethasone
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    5 x 2mg tablets were over-encapsulated into one capsule and was administered orally as single dose.

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    PR1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Matching size 1 capsule using lactose. Administered orally as the IMP

    Number of subjects in period 2 [1]
    		Dexamethasone Placebo
    Started
    175
    174
    Completed
    175
    174
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Data provided in Period 2 relates to the subgroup receiving a delayed antibiotic prescription, as specified in the protocol as a secondary objective.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Dexamethasone
    Reporting group description
    		 10mg oral dexamethasone

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo - Single capsule using lactose

    Reporting group values
    		 Dexamethasone Placebo Total
    Number of subjects
    		 293 283 576
    Age categorical
    Age at randomisation
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 3 3
        Adults (18-64 years)
    		 276 267 543
        From 65-84 years
    		 16 10 26
        85 years and over
    		 1 3 4
    Age continuous
    Age at randomisation
    Units: years
        arithmetic mean (inter-quartile range (Q1-Q3))
    		 33.7 (26.2 to 45.7) 34.2 (25.6 to 45) -
    Gender categorical
    Units: Subjects
        Female
    		 226 210 436
        Male
    		 67 73 140
    Smoking status
    Units: Subjects
        Non-smoker
    		 197 177 374
        Smoker
    		 53 52 105
        Ex-smoker
    		 43 54 97
    In paid work or education
    Units: Subjects
        No
    		 71 62 133
        Full-Time
    		 175 175 350
        Part-Time
    		 47 46 93
    Study centre
    Units: Subjects
        Bristol
    		 79 73 152
        Oxford
    		 144 141 285
        Southampton
    		 70 69 139
    Symptoms - sore throat
    Units: Subjects
        None
    		 0 0 0
        Slight
    		 11 9 20
        Moderate
    		 187 179 366
        Severe
    		 95 95 190
    Symptom - runny nose in last 24 hours
    Units: Subjects
        None
    		 165 144 309
        Slight
    		 75 80 155
        Moderate
    		 47 53 100
        Severe
    		 6 6 12
    Symptom - runny nose during illness
    Units: Subjects
        None
    		 163 150 313
        Slight
    		 81 84 165
        Moderate
    		 44 42 86
        Severe
    		 5 7 12
    Symptom - cough in last 24 hours
    Units: Subjects
        None
    		 131 117 248
        Sligt
    		 84 89 173
        Moderate
    		 61 64 125
        Severe
    		 17 13 30
    Symptom - cough during illness
    Units: Subjects
        None
    		 128 113 241
        Slight
    		 88 90 178
        Moderate
    		 65 68 133
        Severe
    		 12 12 24
    Symptom - hoarse in last 24 hours
    Units: Subjects
        None
    		 114 99 213
        Slight
    		 93 97 190
        Moderate
    		 59 61 120
        Severe
    		 27 26 53
    Symptom - hoarse voice during illness
    Units: Subjects
        None
    		 112 90 202
        Slight
    		 99 108 207
        Moderate
    		 63 67 130
        Severe
    		 19 18 37
    Symptom - disturbed sleep
    Units: Subjects
        None
    		 68 60 128
        Slight
    		 70 68 138
        Moderate
    		 91 97 188
        Severe
    		 64 58 122
    Symptom - difficulty swallowing
    Units: Subjects
        None
    		 17 15 32
        Slight
    		 74 68 142
        Moderate
    		 133 139 272
        Severe
    		 69 61 130
    Symptom - generally unwell
    Units: Subjects
        None
    		 46 45 91
        Slight
    		 97 73 170
        Moderate
    		 129 140 269
        Severe
    		 21 25 46
    Symptom - fever in last 24 hours
    Units: Subjects
        None
    		 131 137 268
        Slight
    		 82 73 155
        Moderate
    		 70 59 129
        Severe
    		 10 14 24
    Symptom - fever during illness
    Units: Subjects
        None
    		 127 130 257
        Slight
    		 81 71 152
        Moderate
    		 74 68 142
        Severe
    		 11 14 25
    Symptom - headache
    Units: Subjects
        None
    		 135 113 248
        Slight
    		 76 74 150
        Moderate
    		 65 75 140
        Severe
    		 17 21 38
    Symptom -muscle ache
    Units: Subjects
        None
    		 150 132 282
        Slight
    		 66 69 135
        Moderate
    		 58 64 122
        Severe
    		 19 18 37
    Symptom - abdominal pain
    Units: Subjects
        None
    		 255 245 500
        Slight
    		 27 25 52
        Moderate
    		 10 9 19
        Severe
    		 1 4 5
    Symptom - diarrhoea
    Units: Subjects
        None
    		 271 262 533
        Slight
    		 18 14 32
        Moderate
    		 4 4 8
        Severe
    		 0 3 3
    Symptom - vomiting
    Units: Subjects
        None
    		 279 268 547
        Slight
    		 8 10 18
        Moderate
    		 6 4 10
        Severe
    		 0 1 1
    Symptom - earache
    Units: Subjects
        None
    		 161 176 337
        Slight
    		 83 61 144
        Moderate
    		 40 36 76
        Severe
    		 9 10 19
    Physical examination
    Units: Subjects
        None
    		 34 29 63
        Slight
    		 74 65 139
        Moderate
    		 163 170 333
        Severe
    		 22 19 41
    Presence of tonsils
    Units: Subjects
        No
    		 89 88 177
        Yes
    		 204 195 399
    Cervical lymphadenopathy
    Units: Subjects
        No
    		 158 158 316
        Yes
    		 135 125 260
    Delayed antibiotic prescription
    Units: Subjects
        No
    		 175 174 349
        Yes
    		 118 109 227
    Fever PAIN score
    Units: Subjects
        Low (0-1)
    		 147 146 293
        Intermediate (2-3)
    		 140 132 272
        High (4-5)
    		 6 5 11
    Centor Score
    Units: Subjects
        Not severe (<=2)
    		 252 242 494
        Severe (>2)
    		 41 41 82
    Throat swab completed
    Units: Subjects
        No
    		 28 35 63
        Yes
    		 265 248 513
    Inflamed Tonsils
    Only those who have presence of tonsils
    Units: Subjects
        None
    		 68 71 139
        Slight
    		 52 36 88
        Moderate
    		 75 83 158
        Severe
    		 9 5 14
        N/A
    		 89 88 177
    Purulent tonsils
    Only those who had presence of tonsils
    Units: Subjects
        No
    		 173 164 337
        Yes
    		 31 31 62
        N/A
    		 89 88 177
    Tender cervical lymphadenopathy
    If cervical lymphadenopathy = yes
    Units: Subjects
        No
    		 37 31 68
        Yes
    		 98 94 192
        N/A
    		 158 158 316
    Delayed antibiotic prescription
    Units: Subjects
        No
    		 175 174 349
        Yes
    		 118 109 227
    Delayed Antibiotic prescription medication
    If delayed antibiotic prescription = yes
    Units: Subjects
        Penicillin PV
    		 93 75 168
        Erythromycin
    		 1 6 7
        Clarithromycin
    		 8 6 14
        Doxycycline
    		 2 1 3
        Co-amoxiclav (augmentin)
    		 0 3 3
        Amoxicillin
    		 13 17 30
        Other
    		 1 1 2
        N/A
    		 175 174 349
    Streptococcal Group A
    If throat swab completed = yes
    Units: Subjects
        No significant growth
    		 234 214 448
        Organism isolated
    		 31 34 65
        N/A
    		 28 35 63
    Streptococcal group C
    If throat swab completed = yes
    Units: Subjects
        No significant growth
    		 258 238 496
        Organism isolated
    		 7 10 17
        N/A
    		 28 35 63
    Streptococcal group G
    If throat swab completed = yes
    Units: Subjects
        No significant growth
    		 264 245 509
        Organism isolated
    		 1 3 4
        N/A
    		 28 35 63
    Duration of pain
    Units: Days
        arithmetic mean (standard deviation)
    		 3.9 ( 2 ) 3.9 ( 1.8 ) -
    Duration of sore throat
    Units: Days
        arithmetic mean (standard deviation)
    		 3.9 ( 2 ) 3.9 ( 1.8 ) -
    Patient temperature
    Units: degree celcius
        arithmetic mean (standard deviation)
    		 36.8 ( 0.5 ) 36.8 ( 0.6 ) -
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The primary analysis were intention to treat (ITT). All eligible randomised patients were included in the analysis of the primary outcome, assuming no complete resolution for any missing data. Ineligible participants (i.e. not in the target population) who were randomised in error were detailed in the CONSORT flow chart and were excluded from all analyses. Therefore, all endpoints analyses will be identical for ITT and reporting groups.

    Subject analysis sets values
    		 ITT
    Number of subjects
    565
    Age categorical
    Age at randomisation
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    536
        From 65-84 years
    25
        85 years and over
    4
    Age continuous
    Age at randomisation
    Units: years
        arithmetic mean (inter-quartile range (Q1-Q3))
    37.2 (26 to 45.5)
    Gender categorical
    Units: Subjects
        Female
    425
        Male
    140
    Smoking status
    Units: Subjects
        Non-smoker
    368
        Smoker
    103
        Ex-smoker
    94
    In paid work or education
    Units: Subjects
        No
    131
        Full-Time
    341
        Part-Time
    93
    Study centre
    Units: Subjects
        Bristol
    151
        Oxford
    282
        Southampton
    132
    Symptoms - sore throat
    Units: Subjects
        None
    0
        Slight
    20
        Moderate
    362
        Severe
    183
    Symptom - runny nose in last 24 hours
    Units: Subjects
        None
    301
        Slight
    152
        Moderate
    100
        Severe
    12
    Symptom - runny nose during illness
    Units: Subjects
        None
    306
        Slight
    162
        Moderate
    85
        Severe
    12
    Symptom - cough in last 24 hours
    Units: Subjects
        None
    242
        Sligt
    171
        Moderate
    123
        Severe
    29
    Symptom - cough during illness
    Units: Subjects
        None
    236
        Slight
    175
        Moderate
    130
        Severe
    24
    Symptom - hoarse in last 24 hours
    Units: Subjects
        None
    208
        Slight
    189
        Moderate
    115
        Severe
    53
    Symptom - hoarse voice during illness
    Units: Subjects
        None
    197
        Slight
    206
        Moderate
    125
        Severe
    37
    Symptom - disturbed sleep
    Units: Subjects
        None
    123
        Slight
    137
        Moderate
    186
        Severe
    119
    Symptom - difficulty swallowing
    Units: Subjects
        None
    31
        Slight
    140
        Moderate
    186
        Severe
    119
    Symptom - generally unwell
    Units: Subjects
        None
    88
        Slight
    165
        Moderate
    267
        Severe
    45
    Symptom - fever in last 24 hours
    Units: Subjects
        None
    262
        Slight
    152
        Moderate
    127
        Severe
    23
    Symptom - fever during illness
    Units: Subjects
        None
    252
        Slight
    150
        Moderate
    139
        Severe
    24
    Symptom - headache
    Units: Subjects
        None
    244
        Slight
    147
        Moderate
    137
        Severe
    37
    Symptom -muscle ache
    Units: Subjects
        None
    275
        Slight
    133
        Moderate
    120
        Severe
    37
    Symptom - abdominal pain
    Units: Subjects
        None
    490
        Slight
    51
        Moderate
    19
        Severe
    5
    Symptom - diarrhoea
    Units: Subjects
        None
    522
        Slight
    32
        Moderate
    8
        Severe
    3
    Symptom - vomiting
    Units: Subjects
        None
    437
        Slight
    17
        Moderate
    10
        Severe
    1
    Symptom - earache
    Units: Subjects
        None
    230
        Slight
    141
        Moderate
    76
        Severe
    18
    Physical examination
    Units: Subjects
        None
    63
        Slight
    135
        Moderate
    329
        Severe
    38
    Presence of tonsils
    Units: Subjects
        No
    174
        Yes
    391
    Cervical lymphadenopathy
    Units: Subjects
        No
    311
        Yes
    254
    Delayed antibiotic prescription
    Units: Subjects
        No
    342
        Yes
    223
    Fever PAIN score
    Units: Subjects
        Low (0-1)
    288
        Intermediate (2-3)
    266
        High (4-5)
    11
    Centor Score
    Units: Subjects
        Not severe (<=2)
    284
        Severe (>2)
    81
    Throat swab completed
    Units: Subjects
        No
    63
        Yes
    502
    Inflamed Tonsils
    Only those who have presence of tonsils
    Units: Subjects
        None
    138
        Slight
    86
        Moderate
    156
        Severe
    11
        N/A
    174
    Purulent tonsils
    Only those who had presence of tonsils
    Units: Subjects
        No
    330
        Yes
    61
        N/A
    174
    Tender cervical lymphadenopathy
    If cervical lymphadenopathy = yes
    Units: Subjects
        No
    65
        Yes
    189
        N/A
    311
    Delayed antibiotic prescription
    Units: Subjects
        No
    343
        Yes
    223
    Delayed Antibiotic prescription medication
    If delayed antibiotic prescription = yes
    Units: Subjects
        Penicillin PV
    165
        Erythromycin
    7
        Clarithromycin
    14
        Doxycycline
    3
        Co-amoxiclav (augmentin)
    3
        Amoxicillin
    29
        Other
    2
        N/A
    343
    Streptococcal Group A
    If throat swab completed = yes
    Units: Subjects
        No significant growth
    439
        Organism isolated
    63
        N/A
    63
    Streptococcal group C
    If throat swab completed = yes
    Units: Subjects
        No significant growth
    485
        Organism isolated
    17
        N/A
    63
    Streptococcal group G
    If throat swab completed = yes
    Units: Subjects
        No significant growth
    498
        Organism isolated
    4
        N/A
    63
    Duration of pain
    Units: Days
        arithmetic mean (standard deviation)
    3.9 ( 1.7 )
    Duration of sore throat
    Units: Days
        arithmetic mean (standard deviation)
    3.9 ( 1.7 )
    Patient temperature
    Units: degree celcius
        arithmetic mean (standard deviation)
    36.8 ( 0.6 )

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Dexamethasone
    Reporting group description
    		 10mg oral dexamethasone

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo - Single capsule using lactose
    Reporting group title
    Dexamethasone
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The primary analysis were intention to treat (ITT). All eligible randomised patients were included in the analysis of the primary outcome, assuming no complete resolution for any missing data. Ineligible participants (i.e. not in the target population) who were randomised in error were detailed in the CONSORT flow chart and were excluded from all analyses. Therefore, all endpoints analyses will be identical for ITT and reporting groups.

    Primary: Resolution of sore throat 24 hours

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    End point title
    		 Resolution of sore throat 24 hours
    End point description
    Had your sore throat completely resolved 24 hours after taking the medication?
    End point type
    Primary
    End point timeframe
    24 hours
    End point values
    		 Dexamethasone Placebo ITT
    Number of subjects analysed
    288
    277
    565
    Units: subjects
        No
    223
    228
    451
        Yes
    65
    49
    114
    Statistical analysis title
    		 Primary Analysis
    Statistical analysis description
    The primary outcome of resolution of sore throat 24 hours after randomisation was analysed using a log-binomial regression model adjusted for centre and whether or not the patient received a delayed prescription for antibiotics.
    Comparison groups
    Dexamethasone v Placebo
    Number of subjects included in analysis
    565
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.144
    Method
    		 Log-binomial regression model
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.78

    Secondary: Complete resolution of sore throat at 48 hours

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    End point title
    		 Complete resolution of sore throat at 48 hours
    End point description
    End point type
    Secondary
    End point timeframe
    48 hours
    End point values
    		 Dexamethasone Placebo ITT
    Number of subjects analysed
    288
    277
    565
    Units: Subjects
        No
    186
    202
    388
        Yes
    102
    75
    177
    Statistical analysis title
    		 Primary Analysis
    Statistical analysis description
    Adjusted for centre and whether or not the patient received a delayed prescription for antibiotics
    Comparison groups
    Dexamethasone v Placebo
    Number of subjects included in analysis
    565
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.031
    Method
    		 Log-binomial regression model
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.02
         upper limit
    		 1.68

    Secondary: Resolution at 24 hours (delayed antibiotic prescription)

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    End point title
    		 Resolution at 24 hours (delayed antibiotic prescription)
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 Dexamethasone Placebo
    Number of subjects analysed
    173
    169
    Units: Subjects
        No
    130
    137
        Yes
    43
    32
    Statistical analysis title
    		 Secondary analysis
    Statistical analysis description
    Model adjusted for centre
    Comparison groups
    Dexamethasone v Placebo
    Number of subjects included in analysis
    342
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.19
    Method
    		 Log-binomial regression model
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.96

    Secondary: Time to onset of pain relief

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    End point title
    		 Time to onset of pain relief
    End point description
    End point type
    Secondary
    End point timeframe
    within 7 days
    End point values
    		 Dexamethasone Placebo
    Number of subjects analysed
    129
    102
    Units: hours
        median (inter-quartile range (Q1-Q3))
    27.5 (21 to 44.5)
    27 (21.4 to 45.8)
    Statistical analysis title
    		 Secondary analysis
    Statistical analysis description
    Adjusted for delayed antibiotic prescription and centre.
    Comparison groups
    Dexamethasone v Placebo
    Number of subjects included in analysis
    231
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.452
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.106
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.44

    Secondary: Time completed symptom resolution

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    End point title
    		 Time completed symptom resolution
    End point description
    End point type
    Secondary
    End point timeframe
    within 7 days
    End point values
    		 Dexamethasone Placebo
    Number of subjects analysed
    101
    94
    Units: hours
        median (inter-quartile range (Q1-Q3))
    65.8 (41 to 105.9)
    60 (39.8 to 92.3)
    Statistical analysis title
    		 Secondary analysis
    Statistical analysis description
    Adjusted for delayed antibiotic prescription and centre.
    Comparison groups
    Dexamethasone v Placebo
    Number of subjects included in analysis
    195
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.776
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.043
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.781
         upper limit
    		 1.393

    Secondary: Pain on swallowing

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    End point title
    		 Pain on swallowing
    End point description
    Days reporting moderately bad (or worse) symptom over 7 days from treatment onset
    End point type
    Secondary
    End point timeframe
    7 days
    End point values
    		 Dexamethasone Placebo
    Number of subjects analysed
    194
    197
    Units: days
        0 days
    73
    72
        1 day
    41
    54
        2 days
    27
    27
        3 days
    27
    19
        4 days
    12
    11
        5 days
    6
    6
        6 days
    5
    1
        7 days
    3
    7
    Statistical analysis title
    		 Secondary outcome analysis
    Statistical analysis description
    Adjusted for delayed prescriptions at baseline and centre, and including the number of completed diary as an offset.
    Comparison groups
    Dexamethasone v Placebo
    Number of subjects included in analysis
    391
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.569
    Method
    		 Negative binomial model
    Parameter type
    		 Incidence rate ratio
    Point estimate
    1.075
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.837
         upper limit
    		 1.381

    Secondary: Sore throat

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    End point title
    		 Sore throat
    End point description
    Days reporting moderately bad (or worse) symptom over 7 days from treatment onset
    End point type
    Secondary
    End point timeframe
    7 days
    End point values
    		 Dexamethasone Placebo
    Number of subjects analysed
    194
    197
    Units: Subjects
        0 days
    58
    54
        1 day
    44
    55
        2 days
    27
    30
        3 days
    26
    22
        4 days
    18
    18
        5 days
    8
    5
        6 days
    7
    3
        7 days
    6
    10
    Statistical analysis title
    		 Secondary outcome analysis
    Statistical analysis description
    The total number of days reporting at least moderately bad symptoms were analysed using a negative binomial model adjusting for centre, delayed prescriptions at baseline and including the number of completed diary days as an offset.
    Comparison groups
    Placebo v Dexamethasone
    Number of subjects included in analysis
    391
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.563
    Method
    		 Negative binomial model
    Parameter type
    		 Incidence rate ratio
    Point estimate
    1.068
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.854
         upper limit
    		 1.336

    Secondary: Difficulty swallowing

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    End point title
    		 Difficulty swallowing
    End point description
    Days reporting moderately bad (or worse) symptom over 7 days from treatment onset
    End point type
    Secondary
    End point timeframe
    7 days
    End point values
    		 Dexamethasone Placebo
    Number of subjects analysed
    194
    197
    Units: Subjects
        0 days
    100
    97
        1 day
    33
    41
        2 days
    22
    22
        3 days
    23
    17
        4 days
    7
    9
        5 days
    5
    5
        6 days
    2
    2
        7 days
    2
    4
    Statistical analysis title
    		 Secondary outcome analysis
    Statistical analysis description
    The total number of days reporting at least moderately bad symptoms were analysed using a negative binomial model adjusting for centre, delayed prescriptions at baseline and including the number of completed diary days as an offset.
    Comparison groups
    Dexamethasone v Placebo
    Number of subjects included in analysis
    391
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.947
    Method
    		 Negative binomial model
    Parameter type
    		 Incidence rate ratio
    Point estimate
    1.011
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.738
         upper limit
    		 1.385

    Secondary: Feeling unwell

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    End point title
    		 Feeling unwell
    End point description
    Days reporting moderately bad (or worse) symptom over 7 days from treatment onset
    End point type
    Secondary
    End point timeframe
    7 days
    End point values
    		 Dexamethasone Placebo
    Number of subjects analysed
    194
    197
    Units: Subjects
        0 days
    85
    80
        1 day
    30
    43
        2 days
    23
    25
        3 days
    19
    13
        4 days
    13
    16
        5 days
    9
    8
        6 days
    8
    5
        7 days
    7
    7
    Statistical analysis title
    		 Secondary outcome analysis
    Statistical analysis description
    The total number of days reporting at least moderately bad symptoms were analysed using a negative binomial model adjusting for centre, delayed prescriptions at baseline and including the number of completed diary days as an offset.
    Comparison groups
    Dexamethasone v Placebo
    Number of subjects included in analysis
    391
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.672
    Method
    		 Negative binomial model
    Parameter type
    		 Incidence rate ratio
    Point estimate
    1.064
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.799
         upper limit
    		 1.416

    Secondary: Cough

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    End point title
    		 Cough
    End point description
    Days reporting moderately bad (or worse) symptom over 7 days from treatment onset
    End point type
    Secondary
    End point timeframe
    7 days
    End point values
    		 Dexamethasone Placebo
    Number of subjects analysed
    194
    197
    Units: Subjects
        0 days
    111
    118
        1 day
    14
    25
        2 days
    14
    8
        3 days
    8
    12
        4 days
    7
    6
        5 days
    15
    9
        6 days
    9
    7
        7 days
    16
    12
    Statistical analysis title
    		 Secondary outcome analysis
    Statistical analysis description
    The total number of days reporting at least moderately bad symptoms were analysed using a negative binomial model adjusting for centre, delayed prescriptions at baseline and including the number of completed diary days as an offset.
    Comparison groups
    Dexamethasone v Placebo
    Number of subjects included in analysis
    391
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.329
    Method
    		 Negative binomial model
    Parameter type
    		 Incidence rate ratio
    Point estimate
    1.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.819
         upper limit
    		 1.818

    Secondary: Fever

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    End point title
    		 Fever
    End point description
    Days reporting moderately bad (or worse) symptom over 7 days from treatment onset
    End point type
    Secondary
    End point timeframe
    7 days
    End point values
    		 Dexamethasone Placebo
    Number of subjects analysed
    194
    197
    Units: Subjects
        0 days
    157
    148
        1 day
    19
    29
        2 days
    10
    7
        3 days
    6
    6
        4 days
    0
    5
        5 days
    1
    1
        6 days
    0
    1
        7 days
    1
    0
    Statistical analysis title
    		 Secondary outcome analysis
    Statistical analysis description
    The total number of days reporting at least moderately bad symptoms were analysed using a negative binomial model adjusting for centre, delayed prescriptions at baseline and including the number of completed diary days as an offset.
    Comparison groups
    Dexamethasone v Placebo
    Number of subjects included in analysis
    391
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.173
    Method
    		 Negative binomial model
    Parameter type
    		 Incidence rate ratio
    Point estimate
    0.684
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.396
         upper limit
    		 1.181

    Secondary: Sleep disturbance

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    End point title
    		 Sleep disturbance
    End point description
    Days reporting moderately bad (or worse) symptom over 7 days from treatment onset
    End point type
    Secondary
    End point timeframe
    7 days
    End point values
    		 Dexamethasone Placebo
    Number of subjects analysed
    194
    197
    Units: Subjects
        0 days
    99
    98
        1 day
    32
    40
        2 days
    20
    19
        3 days
    16
    12
        4 days
    10
    9
        5 days
    4
    7
        6 days
    1
    3
        7 days
    12
    9
    Statistical analysis title
    		 Secondary outcome analysis
    Statistical analysis description
    The total number of days reporting at least moderately bad symptoms were analysed using a negative binomial model adjusting for centre, delayed prescriptions at baseline and including the number of completed diary days as an offset.
    Comparison groups
    Dexamethasone v Placebo
    Number of subjects included in analysis
    391
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.595
    Method
    		 Negative binomial model
    Parameter type
    		 Incidence rate ratio
    Point estimate
    1.095
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.783
         upper limit
    		 1.533

    Secondary: Tender glands in neck

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    End point title
    		 Tender glands in neck
    End point description
    Days reporting moderately bad (or worse) symptom over 7 days from treatment onset
    End point type
    Secondary
    End point timeframe
    7 days
    End point values
    		 Dexamethasone Placebo
    Number of subjects analysed
    194
    197
    Units: Subjects
        0 days
    149
    146
        1 day
    14
    29
        2 days
    15
    5
        3 days
    4
    5
        4 days
    3
    6
        5 days
    3
    2
        6 days
    3
    2
        7 days
    3
    2
    Statistical analysis title
    		 Secondary outcome analysis
    Statistical analysis description
    The total number of days reporting at least moderately bad symptoms were analysed using a negative binomial model adjusting for centre, delayed prescriptions at baseline and including the number of completed diary days as an offset.
    Comparison groups
    Dexamethasone v Placebo
    Number of subjects included in analysis
    391
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.89
    Method
    		 Negative binomial model
    Parameter type
    		 Incidence rate ratio
    Point estimate
    0.974
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.674
         upper limit
    		 1.408

    Secondary: Change in mood

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    End point title
    		 Change in mood
    End point description
    Days reporting moderately bad (or worse) symptom over 7 days from treatment onset
    End point type
    Secondary
    End point timeframe
    7 days
    End point values
    		 Dexamethasone Placebo
    Number of subjects analysed
    194
    197
    Units: Subjects
        0 days
    149
    146
        1 day
    14
    29
        2 days
    15
    5
        3 days
    4
    5
        4 days
    3
    6
        5 days
    3
    2
        6 days
    3
    2
        7 days
    3
    2
    Statistical analysis title
    		 Secondary outcome analysis
    Statistical analysis description
    The total number of days reporting at least moderately bad symptoms were analysed using a negative binomial model adjusting for centre, delayed prescriptions at baseline and including the number of completed diary days as an offset.
    Comparison groups
    Dexamethasone v Placebo
    Number of subjects included in analysis
    391
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.37
    Method
    		 Negative binomial model
    Parameter type
    		 Incidence rate ratio
    Point estimate
    1.283
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.745
         upper limit
    		 2.21

    Secondary: Vomiting

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    End point title
    		 Vomiting
    End point description
    Days reporting moderately bad (or worse) symptom over 7 days from treatment onset
    End point type
    Secondary
    End point timeframe
    7 days
    End point values
    		 Dexamethasone Placebo
    Number of subjects analysed
    194
    197
    Units: Subjects
        0 days
    186
    189
        1 day
    5
    4
        2 days
    1
    3
        3 days
    0
    1
        4 days
    0
    0
        5 days
    0
    0
        6 days
    0
    0
        7 days
    2
    0
    Statistical analysis title
    		 Secondary outcome analysis
    Statistical analysis description
    The total number of days reporting at least moderately bad symptoms were analysed using a negative binomial model adjusting for centre, delayed prescriptions at baseline and including the number of completed diary days as an offset.
    Comparison groups
    Placebo v Dexamethasone
    Number of subjects included in analysis
    391
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.815
    Method
    		 Negative binomial model
    Parameter type
    		 Incidence rate ratio
    Point estimate
    1.174
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.305
         upper limit
    		 4.514

    Secondary: Uptake of delayed antibiotic prescription

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    End point title
    		 Uptake of delayed antibiotic prescription
    End point description
    End point type
    Secondary
    End point timeframe
    7 days
    End point values
    		 Dexamethasone Placebo
    Number of subjects analysed
    115
    108
    Units: Subjects
        No
    36
    30
        Yes
    79
    78
    Statistical analysis title
    		 Secondary outcome analysis
    Statistical analysis description
    Adjusted for centre
    Comparison groups
    Dexamethasone v Placebo
    Number of subjects included in analysis
    223
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.233
    Method
    		 Log-binomial regression model
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.831
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.613
         upper limit
    		 1.126

    Secondary: Sore throat pain

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    End point title
    		 Sore throat pain
    End point description
    Summarised as area under the curve over 7 days using trapezoidal rule with estimates from mixed effects repeated measures model adjusting for symptom at baseline, centre, and delayed antibiotic prescription.
    End point type
    Secondary
    End point timeframe
    7 days
    End point values
    		 Dexamethasone Placebo
    Number of subjects analysed
    193
    195
    Units: points
        arithmetic mean (confidence interval 95%)
    181.8 (173.5 to 190)
    179.7 (171.9 to 187.5)
    Statistical analysis title
    		 Secondary outcome analysis
    Comparison groups
    Dexamethasone v Placebo
    Number of subjects included in analysis
    388
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.723
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Point estimate
    2.048
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.282
         upper limit
    		 13.377
    Notes
    [1] - Linear Regression model adjusting for symptom at baseline, centre and delayed antibiotic prescription

    Secondary: Pain on swallowing VAS scores

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    End point title
    		 Pain on swallowing VAS scores
    End point description
    Summarised as area under the curve over 7 days using trapezoidal rule with estimates from mixed effects repeated measures model adjusting for symptom at baseline, centre, and delayed antibiotic prescription.
    End point type
    Secondary
    End point timeframe
    7 days
    End point values
    		 Dexamethasone Placebo
    Number of subjects analysed
    193
    194
    Units: points
        arithmetic mean (confidence interval 95%)
    163.3 (153.6 to 173)
    165 (155.9 to 174.1)
    Statistical analysis title
    		 Secondary outcome analysis
    Comparison groups
    Dexamethasone v Placebo
    Number of subjects included in analysis
    387
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.798
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Point estimate
    -1.728
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.985
         upper limit
    		 11.529

    Secondary: Difficulty swallowing scores VAS

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    End point title
    		 Difficulty swallowing scores VAS
    End point description
    Summarised as area under the curve over 7 days using trapezoidal rule with estimates from mixed effects repeated measures model adjusting for symptom at baseline, centre, and delayed antibiotic prescription.
    End point type
    Secondary
    End point timeframe
    7 days
    End point values
    		 Dexamethasone Placebo
    Number of subjects analysed
    193
    193
    Units: points
        arithmetic mean (confidence interval 95%)
    134.6 (124 to 145.2)
    143.5 (133.2 to 153.8)
    Statistical analysis title
    		 Secondary outcome analysis
    Comparison groups
    Dexamethasone v Placebo
    Number of subjects included in analysis
    386
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.236
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Point estimate
    -8.904
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23.646
         upper limit
    		 5.838

    Secondary: Use of OTC or prescribed medication for sore throat

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    End point title
    		 Use of OTC or prescribed medication for sore throat
    End point description
    End point type
    Secondary
    End point timeframe
    7 days
    End point values
    		 Dexamethasone Placebo
    Number of subjects analysed
    288
    277
    Units: Subjects
        No
    156
    152
        Yes
    50
    59
        Missing
    82
    66
    Statistical analysis title
    		 Secondary outcome analysis
    Statistical analysis description
    Log binomial model adjusted for centre and delayed antibiotic prescription
    Comparison groups
    Dexamethasone v Placebo
    Number of subjects included in analysis
    565
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.834
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.625
         upper limit
    		 1.114

    Secondary: Use of OTC or prescribed antibiotics for other reasons

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    End point title
    		 Use of OTC or prescribed antibiotics for other reasons
    End point description
    End point type
    Secondary
    End point timeframe
    7 days
    End point values
    		 Dexamethasone Placebo
    Number of subjects analysed
    288
    277
    Units: Subjects
        No
    201
    202
        Yes
    5
    9
        Missing
    82
    66
    Statistical analysis title
    		 Secondary outcome analysis
    Statistical analysis description
    Log binomial model adjusted for centre and delayed antibiotic prescription
    Comparison groups
    Dexamethasone v Placebo
    Number of subjects included in analysis
    565
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.581
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.199
         upper limit
    		 1.701

    Secondary: Use of OTC or prescribed oral or topical analgesia

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    End point title
    		 Use of OTC or prescribed oral or topical analgesia
    End point description
    End point type
    Secondary
    End point timeframe
    7 days
    End point values
    		 Dexamethasone Placebo
    Number of subjects analysed
    288
    277
    Units: Subjects
        No
    59
    57
        Yes
    147
    154
        Missing
    82
    66
    Statistical analysis title
    		 Secondary outcome analysis
    Statistical analysis description
    Log binomial model adjusted for centre and delayed antibiotic prescription
    Comparison groups
    Dexamethasone v Placebo
    Number of subjects included in analysis
    565
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.983
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.874
         upper limit
    		 1.105

    Secondary: Use of GP practices, A&E, OOO centres

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    End point title
    		 Use of GP practices, A&E, OOO centres
    End point description
    Use of any GP practice, A&E OOO centres and telephone contact in the 28 days following the initial trial appointment
    End point type
    Secondary
    End point timeframe
    28 days
    End point values
    		 Dexamethasone Placebo
    Number of subjects analysed
    288
    277
    Units: Subjects
        Yes - associated with sore throat
    36
    25
        No or not associated with sore throat
    252
    252
    Statistical analysis title
    		 Secondary outcome analysis
    Statistical analysis description
    Log binomial model adjusted for centre and delayed antibiotic prescription
    Comparison groups
    Dexamethasone v Placebo
    Number of subjects included in analysis
    565
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.175
    Method
    		 Log-binomial regression model
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.392
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.863
         upper limit
    		 2.244

    Secondary: Time missed from work or education over 7 days

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    End point title
    		 Time missed from work or education over 7 days
    End point description
    End point type
    Secondary
    End point timeframe
    7 days
    End point values
    		 Dexamethasone Placebo
    Number of subjects analysed
    147
    166
    Units: hours
        arithmetic mean (standard deviation)
    6.07 ( 11.3 )
    5.99 ( 10 )
    Statistical analysis title
    		 Secondary outcome analysis
    Statistical analysis description
    Linear regression adjusted for centre and delayed antibiotic prescription.
    Comparison groups
    Dexamethasone v Placebo
    Number of subjects included in analysis
    313
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.846
    Method
    		 Regression, Linear
    Parameter type
    		 Median difference (net)
    Point estimate
    0.235
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.143
         upper limit
    		 2.612

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    During the trial
    Adverse event reporting additional description
    Dexamethasone is a commonly used medication in a primary care setting; it has well defined safety profiles and is being used in this trial for authorised indications. As a result of this no non-serious adverse events will be recorded in this study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Dexamethasone
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Dexamethasone is a commonly used medication in a primary care setting; it has well defined safety profiles and is being used in this trial for authorised indications. As a result of this no non-serious adverse events will be recorded in this study.
    Serious adverse events
    		 Dexamethasone Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 288 (0.69%)
    3 / 277 (1.08%)
         number of deaths (all causes)
    1
    1
         number of deaths resulting from adverse events
    0
    0
    General disorders and administration site conditions
    Hosptial admission with parapharyngeal abscess
         subjects affected / exposed
    1 / 288 (0.35%)
    0 / 277 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
    Additional description: Hospital admission with pneumonia with subsequent death in the community
         subjects affected / exposed
    0 / 288 (0.00%)
    1 / 277 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Social circumstances
    Death
    Additional description: Patient died. Cause of death murder. No further details available
         subjects affected / exposed
    1 / 288 (0.35%)
    0 / 277 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Infections and infestations
    Tonsilitis
         subjects affected / exposed
    0 / 288 (0.00%)
    1 / 277 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hospital admission with peritonsillar abscess
         subjects affected / exposed
    0 / 288 (0.00%)
    1 / 277 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Dexamethasone Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 277 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Apr 2013
    Clarified one the outcome measures and details of the data collection which has already been approved in order to have complete consistency between all our documentation.
    08 Jul 2013
    Amendment to the sample size and also extending the follow up process through the text message system and with a thank you of a £10 gift voucher once they return all of the follow up documentation.
    02 Sep 2013
    Listed all of our new research sites and have added two further Principal Investigators on the protocol.
    13 Mar 2014
    Introducing an upper age limit of 70 to the inclusion criteria.
    09 Jun 2014
    Listed all of new research sites. In addition, recruitment period has been extended to the end of December 2014.
    30 Jul 2014
    The amendment relates to an increase in the value of the gift card that participants will receive once they have completed and returned their symptom diaries and the addition of a recruiting site. Also have clarified wording within the protocol relating to timelines for reporting SAEs.
    03 Mar 2015
    The amendment details the addition of a new research site.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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