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    Clinical Trial Results:
    A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Oral Azithromycin (500 Mg OD) as a Supplement to Standard Care for Adult Patients with Acute Exacerbations of Asthma

    Summary
    EudraCT number
    2011-001093-26
    Trial protocol
    GB  
    Global end of trial date
    30 Jun 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    10 Jun 2016
    First version publication date
    10 Jun 2016
    Other versions
    Summary report(s)
    AZALEA Final Report - CSR

    Trial information

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    Trial identification
    Sponsor protocol code
    AZALEA
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01444469
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Imperial College, London
    Sponsor organisation address
    Exhibition Road, London, United Kingdom, SW7 2AZ
    Public contact
    Professor Sebastian Johnston, Imperial College, London, 020 7 594 3764, s.johnston@imperial.ac.uk
    Scientific contact
    Professor Sebastian Johnston, Imperial College, London, 020 7 594 3764, s.johnston@imperial.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
    24 Jul 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jun 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jun 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the clinical efficacy of oral Azithromycin treatment as a supplement to standard care for adult patients with acute exacerbations of asthma.
    Protection of trial subjects
    • Addition of an extra exclusion criteria during the study to reflect guidelines released from the FDA on the use of azithromycin
    Background therapy
    N/A
    Evidence for comparator
    N/A placebo used
    Actual start date of recruitment
    17 Oct 2011
    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: 199
    Worldwide total number of subjects
    199
    EEA total number of subjects
    199
    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)
    184
    From 65 to 84 years
    15
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Recruitment ran from 17th October 2011 to 30th June 2014 across 31 UK sites, one of which was a primary care / GP site.

    Pre-assignment
    Screening details
    4582 patients were screened for eligibility. 4383 were excluded.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor
    Blinding implementation details
    The identity of the study medications was blinded, packaged and supplied to the investigator by Sharp Clinical Services with code break envelopes. Over-encapsulated azithromycin capsules and placebo capsules were placed into child-resistant tamper-evident containers and a randomised label applied to each container.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Treatment Arm / Azithromycin
    Arm description
    Those randomised to azithromycin received 500 mg azithromycin (two 250 mg capsules) once a day for 3 days (this is the routine dose given in clinical care).
    Arm type
    Experimental

    Investigational medicinal product name
    Azithromycin
    Investigational medicinal product code
    J01FA10
    Other name
    ZITHROMAX™ CAPSULES
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Those randomised to azithromycin received 500 mg azithromycin (two 250 mg capsules) once a day for 3 days (this is the routine dose given in clinical care). This was self administered, the first dose administered at the site in the presence of research staff and all subsequent doses taken at home.

    Arm title
    Placebo
    Arm description
    Those patients randomised to the placebo received two placebo capsules once a day for 3 days.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Those patients randomised to the placebo received two placebo capsules once a day for 3 days.

    Number of subjects in period 1
    Treatment Arm / Azithromycin Placebo
    Started
    97
    102
    Completed
    97
    102

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    -

    Reporting group values
    Overall trial Total
    Number of subjects
    199 199
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    199 199
    Gender categorical
    Units: Subjects
        Female
    139 139
        Male
    60 60

    End points

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    End points reporting groups
    Reporting group title
    Treatment Arm / Azithromycin
    Reporting group description
    Those randomised to azithromycin received 500 mg azithromycin (two 250 mg capsules) once a day for 3 days (this is the routine dose given in clinical care).

    Reporting group title
    Placebo
    Reporting group description
    Those patients randomised to the placebo received two placebo capsules once a day for 3 days.

    Primary: Diary card summary symptom score

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    End point title
    Diary card summary symptom score
    End point description
    End point type
    Primary
    End point timeframe
    10 days after randomisation
    End point values
    Treatment Arm / Azithromycin Placebo
    Number of subjects analysed
    71
    68
    Units: Symptom score
    71
    68
    Statistical analysis title
    Multilevel model of the primary outcome
    Statistical analysis description
    Multilevel modelling was used to calculate the unbiased estimates of differences in diary scores for each day between the treatment arms. Different relationships between time and diary scores were compared including linear, quadratic and square root relationships. Fixed and random effects and the use of splines were also investigated. The goodness of fit of these models were assessed by residual plots. All patients who returned at least one diary card (and received study drug) were included
    Comparison groups
    Treatment Arm / Azithromycin v Placebo
    Number of subjects included in analysis
    139
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.166
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.67
         upper limit
    0.337

    Secondary: Health status assessed by acute asthma QoLQ (Juniper)

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    End point title
    Health status assessed by acute asthma QoLQ (Juniper)
    End point description
    End point type
    Secondary
    End point timeframe
    Assessed at day baseline and days 5 and 10 after randomisation
    End point values
    Treatment Arm / Azithromycin Placebo
    Number of subjects analysed
    80
    83
    Units: Questionnaire score
        Baseline
    96
    100
        5 days post randomisation
    84
    87
        10 days post randomisation
    80
    83
    Statistical analysis title
    Multilevel model of the secondary outcomes
    Statistical analysis description
    Multilevel models, similar to those specified for the primary outcome, were used to analyse the acute asthma and mini-asthma questionnaires and also for the pulmonary function tests.
    Comparison groups
    Treatment Arm / Azithromycin v Placebo
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    0.13
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.276
         upper limit
    0.539

    Secondary: Health status assessed by Mini Asthma QoLQ (Juniper)

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    End point title
    Health status assessed by Mini Asthma QoLQ (Juniper)
    End point description
    End point type
    Secondary
    End point timeframe
    Assessed at Baseline and at 5 and 10 days post randomisation
    End point values
    Treatment Arm / Azithromycin Placebo
    Number of subjects analysed
    96
    100
    Units: Questionnaire score
        Baseline
    96
    100
        5 days post randomisation
    84
    87
        10 days post randomisation
    80
    83
    Statistical analysis title
    Multilevel model of the secondary outcomes
    Comparison groups
    Treatment Arm / Azithromycin v Placebo
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.042
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.409
         upper limit
    0.325

    Secondary: Pulmonary Function tests (FEV1, FVC, FEV1/FVC ratio, PEF, FEF25-75%, FEF50%)

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    End point title
    Pulmonary Function tests (FEV1, FVC, FEV1/FVC ratio, PEF, FEF25-75%, FEF50%)
    End point description
    End point type
    Secondary
    End point timeframe
    Assessed at Baseline and 5 and 10 days post randomisation
    End point values
    Treatment Arm / Azithromycin Placebo
    Number of subjects analysed
    80
    83
    Units: FEV1, FVC, FEV1/FVC ratio, PEF, FEF25-75
        Baseline
    97
    101
        5 days post randomisation
    85
    90
        10 days post randomisation
    80
    83
    Statistical analysis title
    Multilevel model of FEV1
    Comparison groups
    Treatment Arm / Azithromycin v Placebo
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    0.05
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.132
         upper limit
    0.231
    Statistical analysis title
    Multilevel model of FVC
    Comparison groups
    Treatment Arm / Azithromycin v Placebo
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    0.038
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.166
         upper limit
    0.243
    Statistical analysis title
    Multilevel model of FEV1/FVC ratio
    Comparison groups
    Treatment Arm / Azithromycin v Placebo
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    1.379
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.559
         upper limit
    4.316
    Statistical analysis title
    Multilevel model of FEF25-75%(litres/sec)
    Comparison groups
    Treatment Arm / Azithromycin v Placebo
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    0.036
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.192
         upper limit
    0.265
    Statistical analysis title
    Multilevel model of FEF50%(litres/sec)
    Comparison groups
    Treatment Arm / Azithromycin v Placebo
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    0.045
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.234
         upper limit
    0.324
    Statistical analysis title
    Multilevel model of PEF(litres/min)
    Comparison groups
    Treatment Arm / Azithromycin v Placebo
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    18.03
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -8.56
         upper limit
    44.62

    Secondary: Time to 50% reduction in symptom score

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    End point title
    Time to 50% reduction in symptom score
    End point description
    End point type
    Secondary
    End point timeframe
    Time from day 1 to 50% reduction in initial symptom score was calculated using the mean daytime score from the diary cards.
    End point values
    Treatment Arm / Azithromycin Placebo
    Number of subjects analysed
    97
    102
    Units: Symptom score
    97
    102
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    For the purposes of this study, the period of observation extended from the time the subject gave informed consent until 7 days after the last dose of study medication.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Active
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Serious adverse events
    Active Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 97 (1.03%)
    3 / 102 (2.94%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 97 (1.03%)
    2 / 102 (1.96%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 102 (0.98%)
         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: 1%
    Non-serious adverse events
    Active Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    51 / 97 (52.58%)
    52 / 102 (50.98%)
    Cardiac disorders
    Chest pain
         subjects affected / exposed
    4 / 97 (4.12%)
    1 / 102 (0.98%)
         occurrences all number
    4
    1
    Tachycardia
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    Palpitations
         subjects affected / exposed
    1 / 97 (1.03%)
    1 / 102 (0.98%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    chronic throat clearing
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    Dyspnoea
         subjects affected / exposed
    6 / 97 (6.19%)
    8 / 102 (7.84%)
         occurrences all number
    6
    8
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 97 (1.03%)
    2 / 102 (1.96%)
         occurrences all number
    1
    2
    Chest discomfort
         subjects affected / exposed
    2 / 97 (2.06%)
    1 / 102 (0.98%)
         occurrences all number
    2
    1
    Wheezing
         subjects affected / exposed
    3 / 97 (3.09%)
    1 / 102 (0.98%)
         occurrences all number
    3
    1
    Cough
         subjects affected / exposed
    4 / 97 (4.12%)
    6 / 102 (5.88%)
         occurrences all number
    4
    6
    Asthma
         subjects affected / exposed
    6 / 97 (6.19%)
    4 / 102 (3.92%)
         occurrences all number
    6
    4
    Nasopharyngitis
         subjects affected / exposed
    0 / 97 (0.00%)
    2 / 102 (1.96%)
         occurrences all number
    0
    2
    Productive cough
         subjects affected / exposed
    1 / 97 (1.03%)
    3 / 102 (2.94%)
         occurrences all number
    1
    3
    Pain
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 97 (0.00%)
    2 / 102 (1.96%)
         occurrences all number
    0
    2
    Rhinorrhoea
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    Myalgia
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    Pneumonia
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    Sinusitis
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    Haemophilus infection
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    Nervous system disorders
    Neuralgia
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    Dizziness
         subjects affected / exposed
    3 / 97 (3.09%)
    2 / 102 (1.96%)
         occurrences all number
    3
    2
    Headache
         subjects affected / exposed
    11 / 97 (11.34%)
    10 / 102 (9.80%)
         occurrences all number
    11
    10
    Paraesthesia
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    Eye disorders
    Eye pain
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    Visual impairment
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Contusion
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    Blood pressure decreased
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    Dry throat
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    Ear pain
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    asthenia
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    Disturbance in attention
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    Arthropod bite
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    Eye pruritus
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    Pruritus
         subjects affected / exposed
    1 / 97 (1.03%)
    1 / 102 (0.98%)
         occurrences all number
    1
    1
    Decreased appetite
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    Hyperhidrosis
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    2 / 97 (2.06%)
    1 / 102 (0.98%)
         occurrences all number
    2
    1
    Fatigue
         subjects affected / exposed
    3 / 97 (3.09%)
    6 / 102 (5.88%)
         occurrences all number
    3
    6
    Muscle spasms
         subjects affected / exposed
    0 / 97 (0.00%)
    2 / 102 (1.96%)
         occurrences all number
    0
    2
    Tooth fracture
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    Lip dry
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    Rash
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    Feeling of body temperature change
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    Hot flush
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    Epistaxis
         subjects affected / exposed
    2 / 97 (2.06%)
    1 / 102 (0.98%)
         occurrences all number
    2
    1
    Erythema
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    Ill-defined disorder
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    Toothache
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    Emotional distress
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    Panic attack
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 97 (3.09%)
    0 / 102 (0.00%)
         occurrences all number
    3
    0
    Abdominal distension
         subjects affected / exposed
    3 / 97 (3.09%)
    1 / 102 (0.98%)
         occurrences all number
    3
    1
    constipation
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    diarrhoea
         subjects affected / exposed
    8 / 97 (8.25%)
    7 / 102 (6.86%)
         occurrences all number
    8
    7
    Malaise
         subjects affected / exposed
    1 / 97 (1.03%)
    2 / 102 (1.96%)
         occurrences all number
    1
    2
    Dyspepsia
         subjects affected / exposed
    4 / 97 (4.12%)
    5 / 102 (4.90%)
         occurrences all number
    4
    5
    Nausea
         subjects affected / exposed
    6 / 97 (6.19%)
    4 / 102 (3.92%)
         occurrences all number
    6
    4
    Reflux gastritis
         subjects affected / exposed
    2 / 97 (2.06%)
    1 / 102 (0.98%)
         occurrences all number
    2
    1
    Abdominal pain upper
         subjects affected / exposed
    6 / 97 (6.19%)
    3 / 102 (2.94%)
         occurrences all number
    6
    3
    Abdominal discomfort
         subjects affected / exposed
    1 / 97 (1.03%)
    2 / 102 (1.96%)
         occurrences all number
    1
    2
    Anal haemorrhage
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 97 (2.06%)
    2 / 102 (1.96%)
         occurrences all number
    2
    2
    Foot fracture
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    1 / 97 (1.03%)
    2 / 102 (1.96%)
         occurrences all number
    1
    2
    Mobility decreased
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    Joint swelling
         subjects affected / exposed
    1 / 97 (1.03%)
    1 / 102 (0.98%)
         occurrences all number
    1
    1
    Flank pain
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Sep 2011
    Protocol amended to Version 2 and included: • Addition of the name of the project manager appointed to this study • Addition of a throat swab in case sufficient sample is not obtained from the nasal mucus and nasal swab • Refinement of inclusion criteria to include FEV1 aswell as PEF as a measurement of lung function • Refinement of exclusion criteria to clarify the type of antibiotic use that will be excluded • Our drug supplier (Bilcare) advised us that the placebo capsules and over-encapsulation of the Zithromax capsules will only use Lactose Powder and not Magnesium Stearate as they had originally specified. This is because they ‘are producing a small amount of capsules that will be made on the hand frame so the Magnesium Stearate powder will not be required’. The protocol was changed accordingly. • Clarification that all standard care for asthma will be permitted • Addition of the option of home visits for study visits 2, 3 and 4 if requested and the patient is unable to attend hospital • Clarification of the leeway allowable for the day of each visit (to allow for weekends and participant unavailability) • Clarification as to when the patients should complete the symptom diaries • Inclusion of a statement that hospitalisation as a direct result of the asthma exacerbation is not an SAE as this is part of their routine clinical care and not related to their participation in the trial • Removal of Appendix C and D (instructions for sample collection and analysis) as this was part of the study specific SOPs that will be regularly reviewed and updated.
    11 Apr 2012
    Protocol amended to Version 3 and included: • Refinement of inclusion criteria to include patients aged over 65 years with less than 5 pack year smoking history • Addition of the telephone number of the project manager appointed to this study
    24 Aug 2012
    Protocol amended to Version 4 and included: • Refinement of the eligibility criteria to include patients presenting within 48 hours (of initial presentation to medical care) with an acute deterioration of asthma control (instead of 24 hours as in the previous protocol version) • To allow for Visit 1 to be conducted at the recruiting site or participant’s home • Recruitment extension to April 2014 • Minor administrative changes
    18 Dec 2012
    Protocol amended to Version 5 and included: • Protocol amendment to introduce participant reimbursements for completing study visits and returning all symptom diaries - participants will be eligible to receive a maximum payment of £50 at visit 4 if they have attended all study visits and completed and returned all 10 symptom diaries. The payment is equivalent to the sum of £10 for attending each study visit (1, 2, 3 and 4) plus £10 for returning all 10 symptom diaries.
    02 Aug 2013
    Protocol amended to Version 6 and included: • Addition of an extra exclusion criteria to reflect guidelines released from the FDA on the use of azithromycin

    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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