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    Clinical Trial Results:
    A Pragmatic Randomised Trial of Ibuprofen, Paracetamol, Steam and Delayed Prescribing for Patients with Respiratory Tract Infections in Primary Care

    Summary
    EudraCT number
    		 2006-005740-83
    Trial protocol
    		 GB  
    Global end of trial date
    03 Dec 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Oct 2020
    First version publication date
    25 Oct 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    4825
    Additional study identifiers
    ISRCTN number
    		 ISRCTN38551726
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Southampton
    Sponsor organisation address
    Highfield, Southampton, United Kingdom, SO16 5ST
    Public contact
    Prof Paul Little, University of Southampton, +44 (0)2380 241060, p.little@soton.ac.uk
    Scientific contact
    Prof Paul Little, University of Southampton, +44 (0)2380 241060, p.little@soton.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
    03 Dec 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Dec 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Dec 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess, in a primary care setting, in patients with respiratory tract infection, whether: 1) there is a difference in the effectiveness between 3 different antipyretic regimes: ibuprofen treatment, paracetamol treatment and combined ibuprofen and paracetamol treatment 2) regular antipyretic dosing gives significantly better symptom and temperature control than 'as required' dosing 3) regular inhalation with steam further improves symptom control 4) there are any differences in antibiotic use and acceptability according to different methods of delaying antibiotic use
    Protection of trial subjects
    None
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Feb 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 889
    Worldwide total number of subjects
    889
    EEA total number of subjects
    889
    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)
    178
    Adolescents (12-17 years)
    68
    Adults (18-64 years)
    557
    From 65 to 84 years
    83
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study carried out a pragmatic randomised factorial trial in a primary care setting in patients with respiratory tract infection. They examined the difference in the effectiveness of three different antipyretic regimens: ibuprofen, paracetamol, and combined ibuprofen and paracetamol.

    Pre-assignment
    Screening details
    		 Patients were excluded if they were asthmatic, had active or previous peptic ulceration, were hypersensitive to analgesics, and were unable to complete outcome measures.

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject
    Blinding implementation details
    A statistician independent of the study team coordinated the randomisation using computer generated random numbers.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 No prescription
    Arm description
    		 No prescription of antibiotics
    Arm type
    		 Experimental

    Investigational medicinal product name
    No intervention
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Other use
    Dosage and administration details
    No intervention

    Arm title
    		 Recontact
    Arm description
    		 Recontacting the clinic to request a prescription by phone
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ibuprofen, paracetamol, or both combined
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ibuprofen, paracetamol, or both combined, four times a day for at least three days Steam - advice to inhale with steam for at least 15 minutes (five minutes three times a day) or asked not to use steam

    Arm title
    		 Post date
    Arm description
    		 post-dating the prescription
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ibuprofen, paracetamol, or both combined
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ibuprofen, paracetamol, or both combined, four times a day for at least three days Steam - advice to inhale with steam for at least 15 minutes (five minutes three times a day) or asked not to use steam

    Arm title
    		 Collection
    Arm description
    		 allowing patients to collect the prescription from the clinic themselves
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ibuprofen, paracetamol, or both combined
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ibuprofen, paracetamol, or both combined, four times a day for at least three days Steam - advice to inhale with steam for at least 15 minutes (five minutes three times a day) or asked not to use steam

    Arm title
    		 Patient led
    Arm description
    		 Giving prescriptions to patients and asking them to wait
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ibuprofen, paracetamol, or both combined
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ibuprofen, paracetamol, or both combined, four times a day for at least three days Steam - advice to inhale with steam for at least 15 minutes (five minutes three times a day) or asked not to use steam

    Arm title
    		 Immediate antibiotics
    Arm description
    		 Immediate antibiotics needed
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ibuprofen, paracetamol, or both combined
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Immediate antibiotics Ibuprofen, paracetamol, or both combined, four times a day for at least three days Steam - advice to inhale with steam for at least 15 minutes (five minutes three times a day) or asked not to use steam

    Number of subjects in period 1
    		No prescription Recontact Post date Collection Patient led Immediate antibiotics
    Started
    123
    108
    114
    105
    106
    333
    Completed
    123
    108
    114
    105
    106
    333

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    No prescription
    Reporting group description
    		 No prescription of antibiotics

    Reporting group title
    Recontact
    Reporting group description
    		 Recontacting the clinic to request a prescription by phone

    Reporting group title
    Post date
    Reporting group description
    		 post-dating the prescription

    Reporting group title
    Collection
    Reporting group description
    		 allowing patients to collect the prescription from the clinic themselves

    Reporting group title
    Patient led
    Reporting group description
    		 Giving prescriptions to patients and asking them to wait

    Reporting group title
    Immediate antibiotics
    Reporting group description
    		 Immediate antibiotics needed

    Reporting group values
    		 No prescription Recontact Post date Collection Patient led Immediate antibiotics Total
    Number of subjects
    		 123 108 114 105 106 333 889
    Age categorical
    Units: Subjects
        Age 3-90 years
    		 123 108 114 105 106 333 889
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 29 ± 22 31 ± 20 34 ± 22 30 ± 20 32 ± 21 37 ± 21 -
    Gender categorical
    Units: Subjects
        Female
    		 76 59 65 63 65 73 401
        Male
    		 46 48 45 41 40 258 478
        unknown
    		 1 1 4 1 1 2 10
    Previous duration
    Units: days
        arithmetic mean (standard deviation)
    		 7.5 ± 7.8 6.3 ± 5.4 6.5 ± 5.2 7.1 ± 7.9 7.2 ± 6.3 8.5 ± 7.7 -
    Mean severity of all symptoms at baseline
    Units: score
        arithmetic mean (standard deviation)
    		 0.94 ± 0.44 0.92 ± 0.42 0.98 ± 0.44 0.99 ± 0.42 0.94 ± 0.42 1.15 ± 0.45 -

    End points

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    End points reporting groups
    Reporting group title
    No prescription
    Reporting group description
    		 No prescription of antibiotics

    Reporting group title
    Recontact
    Reporting group description
    		 Recontacting the clinic to request a prescription by phone

    Reporting group title
    Post date
    Reporting group description
    		 post-dating the prescription

    Reporting group title
    Collection
    Reporting group description
    		 allowing patients to collect the prescription from the clinic themselves

    Reporting group title
    Patient led
    Reporting group description
    		 Giving prescriptions to patients and asking them to wait

    Reporting group title
    Immediate antibiotics
    Reporting group description
    		 Immediate antibiotics needed

    Primary: Mean symptom severity, days 2-4

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    End point title
    		 Mean symptom severity, days 2-4 [1]
    End point description
    The primary outcome was symptom severity measured at the end of each day during days 2-4 of a two week symptom diary
    End point type
    Primary
    End point timeframe
    days 2-4
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Immediate antibiotics not involved to the analyses
    End point values
    		 No prescription Recontact Post date Collection Patient led
    Number of subjects analysed
    123
    108
    114
    105
    106
    Units: crude mean
        arithmetic mean (standard deviation)
    1.62 ± 0.88
    1.60 ± 0.91
    1.82 ± 0.94
    1.68 ± 0.88
    1.75 ± 0.88
    Statistical analysis title
    		 Mean symptom severity, days 2-4
    Comparison groups
    No prescription v Recontact v Post date v Collection v Patient led
    Number of subjects included in analysis
    556
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.625
    Method
    		 likelihood ratio test χ2
    Confidence interval

    Primary: Symptoms rated as moderately bad

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    End point title
    		 Symptoms rated as moderately bad [2]
    End point description
    The diary was completed by patients until symptoms returned to normal. It used previously validated formats for rating symptoms (0=no problem, 6=as bad as it could be). Symptoms included feeling generally unwell, sleep disturbance, fever, interference with normal activities, sore throat, cough, short of breath, facial or sinus pain, earache, and runny or blocked nose.
    End point type
    Primary
    End point timeframe
    2 weeks
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Immediate antibiotics not involved to the analyses
    End point values
    		 No prescription Recontact Post date Collection Patient led
    Number of subjects analysed
    123
    108
    114
    105
    106
    Units: score
        median (inter-quartile range (Q1-Q3))
    3 (2 to 6.5)
    4 (3 to 7)
    4 (3 to 7)
    4 (3 to 7)
    4 (3 to 7)
    Statistical analysis title
    		 Symptoms rated as moderately bad
    Comparison groups
    No prescription v Recontact v Post date v Collection v Patient led
    Number of subjects included in analysis
    556
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.368
    Method
    		 Likelihood ratio test χ2
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    1 month
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    No prescription
    Reporting group description
    		 No prescription of antibiotics

    Reporting group title
    Recontact
    Reporting group description
    		 Recontacting the clinic to request a prescription by phone

    Reporting group title
    Post date
    Reporting group description
    		 post-dating the prescription

    Reporting group title
    Collection
    Reporting group description
    		 allowing patients to collect the prescription from the clinic themselves

    Reporting group title
    Patient led
    Reporting group description
    		 Giving prescriptions to patients and asking them to wait

    Reporting group title
    Immediate antibiotics
    Reporting group description
    		 Immediate antibiotics needed

    Serious adverse events
    		 No prescription Recontact Post date Collection Patient led Immediate antibiotics
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 108 (0.00%)
    0 / 114 (0.00%)
    0 / 105 (0.00%)
    0 / 106 (0.00%)
    0 / 333 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 No prescription Recontact Post date Collection Patient led Immediate antibiotics
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    40 / 123 (32.52%)
    17 / 108 (15.74%)
    34 / 114 (29.82%)
    24 / 105 (22.86%)
    35 / 106 (33.02%)
    131 / 333 (39.34%)
    Investigations
    Complications
         subjects affected / exposed
    3 / 123 (2.44%)
    4 / 108 (3.70%)
    1 / 114 (0.88%)
    1 / 105 (0.95%)
    0 / 106 (0.00%)
    8 / 333 (2.40%)
         occurrences all number
    3
    4
    1
    1
    0
    8
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    8 / 123 (6.50%)
    3 / 108 (2.78%)
    9 / 114 (7.89%)
    7 / 105 (6.67%)
    10 / 106 (9.43%)
    28 / 333 (8.41%)
         occurrences all number
    8
    3
    9
    7
    10
    28
    Vomiting
         subjects affected / exposed
    9 / 123 (7.32%)
    4 / 108 (3.70%)
    8 / 114 (7.02%)
    2 / 105 (1.90%)
    9 / 106 (8.49%)
    25 / 333 (7.51%)
         occurrences all number
    9
    4
    8
    2
    9
    25
    Abdominal pain
         subjects affected / exposed
    15 / 123 (12.20%)
    4 / 108 (3.70%)
    11 / 114 (9.65%)
    13 / 105 (12.38%)
    15 / 106 (14.15%)
    62 / 333 (18.62%)
         occurrences all number
    15
    4
    11
    13
    15
    62
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    5 / 123 (4.07%)
    2 / 108 (1.85%)
    5 / 114 (4.39%)
    1 / 105 (0.95%)
    4 / 106 (3.77%)
    8 / 333 (2.40%)
         occurrences all number
    5
    2
    5
    1
    4
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/24162940
    http://www.ncbi.nlm.nih.gov/pubmed/24603565
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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