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    Clinical Trial Results:
    Mulitcenter, Randomized, Double-Blind Study Comparing the Clinical Effects of Intravenous Montelukast With Placebo in Pediatric Patients (Ages 6 to 14 Years) With Acute Asthma (MK-0476-301)

    Summary
    EudraCT number
    		 2005-002650-22
    Trial protocol
    		 LT  
    Global end of trial date
    17 Mar 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Mar 2016
    First version publication date
    09 May 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    0476-301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00117338
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 SINGULAIR®: tradename, MK-0476-301: Protocol number
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 Mar 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Mar 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study will attempt to find out if the addition of an intravenous form of a drug that is already used for treating asthma in children will help resolve asthma attacks faster than using the current standard care alone. The primary hypothesis of this study is that in pediatric participants with acute asthma, the addition of montelukast to standard therapy will cause a significant improvement in forced expiratory volume in 1 second (FEV1) over the first 60 minutes after administration compared with placebo.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Jul 2005
    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
    Chile: 10
    Country: Number of subjects enrolled
    Colombia: 15
    Country: Number of subjects enrolled
    Guatemala: 24
    Country: Number of subjects enrolled
    India: 35
    Country: Number of subjects enrolled
    Mexico: 43
    Country: Number of subjects enrolled
    Peru: 58
    Country: Number of subjects enrolled
    United States: 75
    Country: Number of subjects enrolled
    Lithuania: 16
    Worldwide total number of subjects
    276
    EEA total number of subjects
    16
    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)
    229
    Adolescents (12-17 years)
    47
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This international study was conducted in study sites in Guatemala, Lithuania, Chile, Peru, India, Mexico, Colombia, and the United Sates.

    Pre-assignment
    Screening details
    		 Of the 395 participants screened for inclusion in this study, 119 participants were excluded during screening and not randomized. One-hundred and ten participants were ineligible for the study, 5 participants withdrew consent, 2 parents withdrew consent, there was one protocol deviation, and 1 participant was excluded for an unknown reason.

    Period 1
    Period 1 title
    Treatment Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo to montelukast sodium for approximately 120 minutes in duration.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Placebo to Montelukast 5.25 mg, 15 mL of the reconstituted study drug will be administered by syringe as a manual bolus over 2 to 5 mintues

    Arm title
    		 Montelukast Intravenous (IV) 5.25 mg
    Arm description
    		 Montelukast 5.25 mg, 15 mL of the reconstituted study drug will be administered by syringe as a manual bolus over 2 to 5 mintues.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    MK-0476, SINGULAIR®
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Montelukast 5.25 mg, 15 mL of the reconstituted study drug will be administered by syringe as a manual bolus over 2 to 5 mintues

    Number of subjects in period 1
    		Placebo Montelukast Intravenous (IV) 5.25 mg
    Started
    131
    145
    Completed
    127
    140
    Not completed
    4
    5
         Consent withdrawn by subject
    -
    1
         Adverse event, non-fatal
    1
    -
         Did not meet Inclusion Criteria
    -
    1
         Lack of efficacy
    1
    -
         Protocol deviation
    2
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo to montelukast sodium for approximately 120 minutes in duration.

    Reporting group title
    Montelukast Intravenous (IV) 5.25 mg
    Reporting group description
    		 Montelukast 5.25 mg, 15 mL of the reconstituted study drug will be administered by syringe as a manual bolus over 2 to 5 mintues.

    Reporting group values
    		 Placebo Montelukast Intravenous (IV) 5.25 mg Total
    Number of subjects
    		 131 145 276
    Age categorical
    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)
    		 112 117 229
        Adolescents (12-17 years)
    		 19 28 47
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 8.9 ( 2.32 ) 9.2 ( 2.36 ) -
    Gender categorical
    Units: Subjects
        Female
    		 50 55 105
        Male
    		 81 90 171
    Race/Ethnicity
    Units: Subjects
        White (Non-Hispanic)
    		 16 16 32
        Black
    		 16 18 34
        Hispanic
    		 53 59 112
        Asian
    		 18 18 36
        Multi-Racial
    		 27 34 61
        Other
    		 1 0 1
    Baseline Forced Expiratory Volume in one second (FEV1)
    FEV1 was measured in Liters (FEV 1 (L). A total of 4/276 (1—montelukast; 3—placebo) randomized participants were excluded from the Full Analysis Set (FAS) of the primary endpoint
    Units: Liters
        arithmetic mean (standard deviation)
    		 1 ( 0.5 ) 1.06 ( 0.5 ) -
    Baseline FEV1 (Percent predicted)
    Percent of predicted baseline Forced Expiratory Volume in one second (FEV1). A total of 4/276 (1—montelukast; 3—placebo) randomized patients were excluded from the Full Analysis Set (FAS) of the primary endpoint.
    Units: Percent
        arithmetic mean (standard deviation)
    		 50.6 ( 17.4 ) 51.8 ( 16.8 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo to montelukast sodium for approximately 120 minutes in duration.

    Reporting group title
    Montelukast Intravenous (IV) 5.25 mg
    Reporting group description
    		 Montelukast 5.25 mg, 15 mL of the reconstituted study drug will be administered by syringe as a manual bolus over 2 to 5 mintues.

    Primary: Time Weighted Average Change from Baseline in FEV1 (Forced Expiratory Volume in 1 Second) Over the First 60 Minutes After Study Drug Administration

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    End point title
    		 Time Weighted Average Change from Baseline in FEV1 (Forced Expiratory Volume in 1 Second) Over the First 60 Minutes After Study Drug Administration
    End point description
    Improvement in FEV1 as the time-weighted average change from baseline over 60 minutes following the end of study drug administration. Time-weighted average of the changes from baseline obtained over the 60 minutes (at 60, 45, 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor. Full Analysis Set (FAS), the FAS population includes all randomized patients who received double-blind study drug, and with efficacy measurements both at baseline and at least one time point over the time interval considered.
    End point type
    Primary
    End point timeframe
    Baseline and (time weighted average over) 60 Minutes
    End point values
    		 Placebo Montelukast Intravenous (IV) 5.25 mg
    Number of subjects analysed
    128 [1]
    144 [2]
    Units: Liters
        least squares mean (confidence interval 95%)
    0.07 (0.01 to 0.12)
    0.08 (0.02 to 0.13)
    Notes
    [1] - The FAS Population
    [2] - The FAS Population
    Statistical analysis title
    		 Improvement in FEV1
    Statistical analysis description
    Statistical Analysis 1 for Improvement in FEV1 (Forced Expiratory Volume in 1 Second) Over the First 60 Minutes After Administration
    Comparison groups
    Placebo v Montelukast Intravenous (IV) 5.25 mg
    Number of subjects included in analysis
    272
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.775 [3]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.06
         upper limit
    		 0.08
    Notes
    [3] - Model terms: treatment, region (US, non-US) and baseline FEV1 as covariate

    Secondary: Change From Baseline in Modified Pulmonary Index [mPI] Score

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    End point title
    		 Change From Baseline in Modified Pulmonary Index [mPI] Score
    End point description
    Change from baseline in modified pulmonary index [mPI] score assessed 60 minutes following the end of study drug administration. mPI questionnaire scores each component on a scale of 0 to 3 (low to high) with a total possible score of 12. The components are respiratory rate, wheezing, prolongation of expiration (Inspiratory:Expiratory ratio), and accessory muscle use. Full Analysis Set (FAS) population includes all randomized patients who received double-blind study drug, and with efficacy measurements both at baseline and at least one time point over the time interval considered.
    End point type
    Secondary
    End point timeframe
    Baseline and 60 minutes
    End point values
    		 Placebo Montelukast Intravenous (IV) 5.25 mg
    Number of subjects analysed
    128 [4]
    143 [5]
    Units: Score on a scale
        least squares mean (confidence interval 95%)
    -2.96 (-3.29 to -2.63)
    -2.95 (-3.26 to -2.63)
    Notes
    [4] - The FAS Population
    [5] - The FAS Population
    Statistical analysis title
    		 Change From Baseline in mPI Score
    Statistical analysis description
    Statistical Analysis 1 for Change From Baseline in Modified Pulmonary Index [mPI] Score
    Comparison groups
    Placebo v Montelukast Intravenous (IV) 5.25 mg
    Number of subjects included in analysis
    271
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.931 [6]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.41
         upper limit
    		 0.45
    Notes
    [6] - Model terms: treatment, region (US, non-US) and baseline FEV1 as covariate

    Secondary: Number of Participants With Treatment Failure (Hospitalization or Time to Decision to Discharge > 2 Hours)

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    End point title
    		 Number of Participants With Treatment Failure (Hospitalization or Time to Decision to Discharge > 2 Hours)
    End point description
    Treatment Failure is defined as a.) patients who required hospitalization, or b.) patients for whom a decision to discharge home has not been reached by 2 hours following the end of study drug administration. Full Analysis Set (FAS). At least one post-randomization measurement obtained subsequent to at least one dose of study treatment was required for inclusion in the analysis of treatment failure endpoint. Baseline FEV1 measurement was also required to assess this endpoint since it was included in the model.
    End point type
    Secondary
    End point timeframe
    120 minutes
    End point values
    		 Placebo Montelukast Intravenous (IV) 5.25 mg
    Number of subjects analysed
    128 [7]
    144 [8]
    Units: Participants
        Hospitalization
    33
    28
        Decision to Discharge Home not Reached by 2 Hours
    26
    37
    Notes
    [7] - The FAS Population
    [8] - The FAS Population
    Statistical analysis title
    		 Number of Participants with Treatment Failure
    Statistical analysis description
    Statistical Analysis 1 for Number of Participants With Treatment Failure (Hospitalization or Time to Decision to Discharge > 2 Hours)
    Comparison groups
    Placebo v Montelukast Intravenous (IV) 5.25 mg
    Number of subjects included in analysis
    272
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [9]
    P-value
    		 = 0.975
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.61
         upper limit
    		 1.61
    Notes
    [9] - Model terms: treatment and baseline FEV1 as covariate

    Secondary: Time-Weighted Average Change in FEV1 Over 45 Minutes Following the End of Study Drug Administration

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    End point title
    		 Time-Weighted Average Change in FEV1 Over 45 Minutes Following the End of Study Drug Administration
    End point description
    Improvement in FEV1 as time-weighted average change from baseline over 45 minutes following the end of study drug administration: Time-weighted average of the changes from baseline obtained over the 45 minutes (at 45, 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor. Full Analysis Set (FAS). The FAS population includes all randomized patients who received double-blind study drug, and with efficacy measurements both at baseline and at least one time point over the time interval considered.
    End point type
    Secondary
    End point timeframe
    Baseline and (time-weighed average over) 45 Minutes
    End point values
    		 Placebo Montelukast Intravenous (IV) 5.25 mg
    Number of subjects analysed
    127 [10]
    142 [11]
    Units: Liters
        least squares mean (confidence interval 95%)
    0.05 (0 to 0.11)
    0.07 (0.02 to 0.12)
    Notes
    [10] - The FAS Population
    [11] - The FAS Population
    Statistical analysis title
    		 Time-Weighted Average Change in FEV1
    Statistical analysis description
    Statistical Analysis 1 for Time-Weighted Average Change in FEV1 Over 45 Minutes Following the End of Study Drug Administration
    Comparison groups
    Placebo v Montelukast Intravenous (IV) 5.25 mg
    Number of subjects included in analysis
    269
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.612 [12]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.05
         upper limit
    		 0.09
    Notes
    [12] - Model terms: treatment, region (US, non-US) and baseline FEV1 as covariate

    Secondary: Time-Weighted Average Change in FEV1 Over 30 Minutes Following the End of Study Drug Administration

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    End point title
    		 Time-Weighted Average Change in FEV1 Over 30 Minutes Following the End of Study Drug Administration
    End point description
    Improvement in FEV1 as the time-weighted average change from baseline over 30 minutes following the end of study drug administration. Time-weighted average of the changes from baseline obtained over the 30 minutes (at 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor. Full Analysis Set (FAS). The FAS population includes all randomized patients who received double-blind study drug, and with efficacy measurements both at baseline and at least one time point over the time interval considered.
    End point type
    Secondary
    End point timeframe
    Baseline and (time-weighted average over) 30 Minutes
    End point values
    		 Placebo Montelukast Intravenous (IV) 5.25 mg
    Number of subjects analysed
    125 [13]
    140 [14]
    Units: Liters
        least squares mean (confidence interval 95%)
    0.05 (0 to 0.11)
    0.06 (0.01 to 0.12)
    Notes
    [13] - The FAS Population
    [14] - The FAS Population
    Statistical analysis title
    		 Time-Weighted Average Change in FEV1
    Statistical analysis description
    Statistical Analysis 1 for Time-Weighted Average Change in FEV1 Over 30 Minutes Following the End of Study Drug Administration
    Comparison groups
    Placebo v Montelukast Intravenous (IV) 5.25 mg
    Number of subjects included in analysis
    265
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.774 [15]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.06
         upper limit
    		 0.08
    Notes
    [15] - Model terms: treatment, region (US, non-US) and baseline FEV1 as covariate

    Secondary: Change in FEV1 After 15 Minutes Following the End of Study Drug Administration

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    End point title
    		 Change in FEV1 After 15 Minutes Following the End of Study Drug Administration
    End point description
    Improvement in FEV1 as the time-weighted average change from baseline over the first 15 minutes following the end of study drug administration. Change = 15 minutes value minus Baseline value Full Analysis Set (FAS). The FAS population includes all randomized patients who received double-blind study drug, and with efficacy measurements both at baseline and at least one time point over the time interval considered.
    End point type
    Secondary
    End point timeframe
    Baseline and 15 Minutes
    End point values
    		 Placebo Montelukast Intravenous (IV) 5.25 mg
    Number of subjects analysed
    115 [16]
    121 [17]
    Units: Liters
        least squares mean (confidence interval 95%)
    0.01 (-0.03 to 0.06)
    0.06 (0.01 to 0.1)
    Notes
    [16] - The FAS Population
    [17] - The FAS Population
    Statistical analysis title
    		 Change in FEV1
    Statistical analysis description
    Statistical Analysis 1 for Change in FEV1 After 15 Minutes Following the End of Study Drug Administration
    Comparison groups
    Placebo v Montelukast Intravenous (IV) 5.25 mg
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.173 [18]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.02
         upper limit
    		 0.11
    Notes
    [18] - Model terms: treatment, region (US, non-US) and baseline FEV1 as covariate

    Secondary: Total Dose of β-agonist Administered Per Patient Over a Period of 2 Hours Following the End of Study Drug Administration

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    End point title
    		 Total Dose of β-agonist Administered Per Patient Over a Period of 2 Hours Following the End of Study Drug Administration
    End point description
    Median total dose of β-agonist administered per patient over a period of 2 hours following the end of study drug administration. At least one post-randomization measurement obtained subsequent to at least one dose of study treatment was required for inclusion in the analysis of total doses of Beta-Agonist (mg) endpoint.
    End point type
    Secondary
    End point timeframe
    120 minutes
    End point values
    		 Placebo Montelukast Intravenous (IV) 5.25 mg
    Number of subjects analysed
    127 [19]
    144 [20]
    Units: mg
        median (inter-quartile range (Q1-Q3))
    0.6 (0 to 3.8)
    1 (0 to 4.3)
    Notes
    [19] - The FAS Population
    [20] - The FAS Population
    Statistical analysis title
    		 Total Dose of β-agonist
    Statistical analysis description
    Statistical Analysis 1 for Total Dose of β-agonist Administered Per Patient Over a Period of 2 Hours Following the End of Study Drug Administration
    Comparison groups
    Placebo v Montelukast Intravenous (IV) 5.25 mg
    Number of subjects included in analysis
    271
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.58 [21]
    Method
    		 ANCOVA
    Parameter type
    		 Median difference (final values)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Notes
    [21] - ANCOVA model (Nonparametric) based on Tukey's normalized ranks with terms treatment, region (US, non-US) and baseline FEV1 as covariate

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 14 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo to montelukast sodium for approximately 120 minutes in duration.

    Reporting group title
    Montelukast
    Reporting group description
    		 Montelukast 5.25 mg, 15 mL of the reconstituted study drug will be administered by syringe as a manual bolus over 2 to 5 mintues.

    Serious adverse events
    		 Placebo Montelukast
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 131 (1.53%)
    2 / 145 (1.38%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Overdose
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthmatic crisis
         subjects affected / exposed
    0 / 131 (0.00%)
    2 / 145 (1.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Pneumonia
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 145 (0.69%)
         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
    		 Placebo Montelukast
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 131 (16.03%)
    20 / 145 (13.79%)
    Vascular disorders
    Diastolic hypotension
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 145 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 145 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    1 / 131 (0.76%)
    5 / 145 (3.45%)
         occurrences all number
    2
    5
    Syncope vasovagal
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    1
    Infusion site extravasation
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 145 (0.00%)
         occurrences all number
    1
    0
    Infusion site pain
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 145 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 131 (0.00%)
    2 / 145 (1.38%)
         occurrences all number
    0
    2
    Constipation
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 145 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    1 / 131 (0.76%)
    1 / 145 (0.69%)
         occurrences all number
    1
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    1 / 131 (0.76%)
    1 / 145 (0.69%)
         occurrences all number
    1
    1
    Vomiting
         subjects affected / exposed
    2 / 131 (1.53%)
    1 / 145 (0.69%)
         occurrences all number
    3
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    7 / 131 (5.34%)
    4 / 145 (2.76%)
         occurrences all number
    8
    4
    Atelectasis
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    1
    Rhinitis allergic
         subjects affected / exposed
    2 / 131 (1.53%)
    0 / 145 (0.00%)
         occurrences all number
    2
    0
    Skin and subcutaneous tissue disorders
    Prurigo
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 145 (0.00%)
         occurrences all number
    1
    0
    Pruritus
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 145 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 145 (0.00%)
         occurrences all number
    1
    0
    Muscle spasms
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    1
    Infections and infestations
    Bronchitis bacterial
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    1
    Gastroenteritis
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 145 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    2 / 131 (1.53%)
    1 / 145 (0.69%)
         occurrences all number
    2
    1
    Pharyngitis
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    1
    Rhinitis
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 145 (0.00%)
         occurrences all number
    1
    0
    Sinusitis
         subjects affected / exposed
    2 / 131 (1.53%)
    0 / 145 (0.00%)
         occurrences all number
    2
    0
    Tonsillitis
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Feb 2005
    Updated study procedures for pulse oximetry and intravenous cathether placement and for the use of β-agonist concomitant medications.
    12 Jun 2006
    Updated study procedures for the modified pulmonary index score during Period I, diluent for the short-acting β-agonists dose, and the prestudy period (standard care) duration.

    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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    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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