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    Clinical Trial Results:
    A Phase Ib Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Bronchodilatory Effect of MK-0476 in Patients with Chronic Asthma

    Summary
    EudraCT number
    2014-004776-27
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    29 Dec 2008

    Results information
    Results version number
    v1(current)
    This version publication date
    22 Feb 2016
    First version publication date
    19 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    0476-388
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00739297
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    MK-0476-388: Merck 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
    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
    29 Dec 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Dec 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Dec 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study tested the safety and effectiveness of a range of doses of MK-0476 (montelukast) compared to placebo on improved lung function based on forced expiratory volume in 1 second (FEV1) in participants aged 15 to 65 years with chronic asthma. This study was a 4-period crossover study during which participants were randomized to receive 3 out of the 5 possible dose strengths of montelukast and 1 dose strength of placebo over the 4 treatment periods using adaptive randomization.
    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
    26 Jun 2008
    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 States: 68
    Worldwide total number of subjects
    68
    EEA total number of subjects
    0
    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)
    2
    Adults (18-64 years)
    65
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Participants were recruited from 6 centers in the United States between July and December 2008.

    Pre-assignment
    Screening details
    117 participants were screened; 49 were excluded. Randomized participants met the following criteria during the prestudy period: FEV1 50-85% predicted while withholding short-acting beta agonist (SABA) and reversibility of airway obstruction >12% following SABA at Visits 1 and 2.

    Period 1
    Period 1 title
    First Intervention (Visit 3 to Visit 4)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Arm title
    Total Population
    Arm description
    Participants were randomized to receive 1 of 3 dose strengths of montelukast or 1 dose strength of placebo at either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol was administered 4 hours after the intervention. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment).
    Arm type
    Total Population

    Investigational medicinal product name
    Placebo for montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo to montelukast 25 mcg or 250 mcg inhalation powder via dry powder inhaler (DPI), administered as a single dose

    Investigational medicinal product name
    Albuterol sulfate
    Investigational medicinal product code
    Other name
    ProAir® HFA
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Albuterol sulfate 90 mcg/actuation, 4 hours after receiving blinded study medication (montelukast or placebo), participants received a single witnessed dose of blinded short-acting beta-agonist (SABA), administered as 2 puffs from a metered dose inhaler (MDI)

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    MK-0476
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Montelukast 25 mcg or 250 mcg inhalation powder via DPI, administered to provide 25 mcg, 100 mcg, 250 mcg, 500 mcg or 1000 mcg montelukast as a single dose

    Investigational medicinal product name
    Placebo for albuterol sulfate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo to albuterol sulfate, 4 hours after receiving blinded study medication (montelukast or placebo), participants received a single witnessed dose of blinded placebo to albuterol, administered as 2 puffs from a MDI

    Number of subjects in period 1
    Total Population
    Started
    68
    Completed
    68
    Period 2
    Period 2 title
    First Washout Period of 4-7 Days
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    No treatment was administered during the washout period.

    Arms
    Arm title
    Total Population
    Arm description
    Participants were randomized to receive 1 of 3 dose strengths of montelukast or 1 dose strength of placebo at either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol was administered 4 hours after the intervention. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment).
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    Total Population
    Started
    68
    Completed
    66
    Not completed
    2
         Adverse event, non-fatal
    2
    Period 3
    Period 3 title
    Second Intervention (Visit 5 to Visit 6)
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Arm title
    Total Population
    Arm description
    Participants were randomized to receive 1 of 3 dose strengths of montelukast or 1 dose strength of placebo at either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol was administered 4 hours after the intervention. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment).
    Arm type
    Total Population

    Investigational medicinal product name
    Placebo for montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo to montelukast 25 mcg or 250 mcg inhalation powder via DPI, administered as a single dose

    Investigational medicinal product name
    Albuterol sulfate
    Investigational medicinal product code
    Other name
    ProAir® HFA
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Albuterol sulfate 90 mcg/actuation, 4 hours after receiving blinded study medication (montelukast or placebo), participants received a single witnessed dose of blinded short-acting beta-agonist (SABA), administered as 2 puffs from a metered dose inhaler (MDI)

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    MK-0476
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Montelukast 25 mcg or 250 mcg inhalation powder via DPI, administered to provide 25 mcg, 100 mcg, 250 mcg, 500 mcg or 1000 mcg montelukast as a single dose

    Investigational medicinal product name
    Placebo for albuterol sulfate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo to albuterol sulfate, 4 hours after receiving blinded study medication (montelukast or placebo), participants received a single witnessed dose of blinded placebo to albuterol, administered as 2 puffs from a MDI

    Number of subjects in period 3
    Total Population
    Started
    66
    Completed
    66
    Period 4
    Period 4 title
    Second Washout Period of 4-7 Days
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    No treatment was administered during the washout period.

    Arms
    Arm title
    Total Population
    Arm description
    Participants were randomized to receive 1 of 3 dose strengths of montelukast or 1 dose strength of placebo at either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol was administered 4 hours after the intervention. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment).
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 4
    Total Population
    Started
    66
    Completed
    66
    Period 5
    Period 5 title
    Third Intervention (Visit 7 to Visit 8)
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Arm title
    Total Population
    Arm description
    Participants were randomized to receive 1 of 3 dose strengths of montelukast or 1 dose strength of placebo at either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol was administered 4 hours after the intervention. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment).
    Arm type
    Total Population

    Investigational medicinal product name
    Placebo for montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo to montelukast 25 mcg or 250 mcg inhalation powder via DPI, administered as a single dose

    Investigational medicinal product name
    Albuterol sulfate
    Investigational medicinal product code
    Other name
    ProAir® HFA
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Albuterol sulfate 90 mcg/actuation, 4 hours after receiving blinded study medication (montelukast or placebo), participants received a single witnessed dose of blinded short-acting beta-agonist (SABA), administered as 2 puffs from a metered dose inhaler (MDI)

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    MK-0476
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Montelukast 25 mcg or 250 mcg inhalation powder via DPI, administered to provide 25 mcg, 100 mcg, 250 mcg, 500 mcg or 1000 mcg montelukast as a single dose

    Investigational medicinal product name
    Placebo for albuterol sulfate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo to albuterol sulfate, 4 hours after receiving blinded study medication (montelukast or placebo), participants received a single witnessed dose of blinded placebo to albuterol, administered as 2 puffs from a MDI

    Number of subjects in period 5
    Total Population
    Started
    66
    Completed
    66
    Period 6
    Period 6 title
    Third Washout Period of 4-7 Days
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    No treatment was administered during the washout period.

    Arms
    Arm title
    Total Population
    Arm description
    Participants were randomized to receive 1 of 3 dose strengths of montelukast or 1 dose strength of placebo at either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol was administered 4 hours after the intervention. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment).
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 6
    Total Population
    Started
    66
    Completed
    66
    Period 7
    Period 7 title
    Fourth Intervention(Visit 9 to Visit 10)
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Arm title
    Total Population
    Arm description
    Participants were randomized to receive 1 of 3 dose strengths of montelukast or 1 dose strength of placebo at either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol was administered 4 hours after the intervention. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment).
    Arm type
    Total Population

    Investigational medicinal product name
    Placebo for montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo to montelukast 25 mcg or 250 mcg inhalation powder via DPI, administered as a single dose

    Investigational medicinal product name
    Albuterol sulfate
    Investigational medicinal product code
    Other name
    ProAir® HFA
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Albuterol sulfate 90 mcg/actuation, 4 hours after receiving blinded study medication (montelukast or placebo), participants received a single witnessed dose of blinded short-acting beta-agonist (SABA), administered as 2 puffs from a metered dose inhaler (MDI)

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    MK-0476
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Montelukast 25 mcg or 250 mcg inhalation powder via DPI, administered to provide 25 mcg, 100 mcg, 250 mcg, 500 mcg or 1000 mcg montelukast as a single dose

    Investigational medicinal product name
    Placebo for albuterol sulfate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo to albuterol sulfate, 4 hours after receiving blinded study medication (montelukast or placebo), participants received a single witnessed dose of blinded placebo to albuterol, administered as 2 puffs from a MDI

    Number of subjects in period 7
    Total Population
    Started
    66
    Completed
    65
    Not completed
    1
         Participant unable to attend last visit
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    First Intervention (Visit 3 to Visit 4)
    Reporting group description
    Participants were randomized to receive 1 of 3 dose strengths of montelukast or 1 dose strength of placebo at either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol was administered 4 hours after the intervention. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment).

    Reporting group values
    First Intervention (Visit 3 to Visit 4) Total
    Number of subjects
    68 68
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    2 2
        Adults (18-64 years)
    65 65
        From 65-84 years
    1 1
        85 years and over
    0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    39.1 ± 12.6 -
    Gender categorical
    Units: Subjects
        Female
    32 32
        Male
    36 36
    FEV1 (Forced Expiratory Volume in One Second)
    FEV1 is the amount of air, in liters, forcibly expired in one second.
    Units: liters
        arithmetic mean (standard deviation)
    2.44 ± 0.63 -

    End points

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    End points reporting groups
    Reporting group title
    Total Population
    Reporting group description
    Participants were randomized to receive 1 of 3 dose strengths of montelukast or 1 dose strength of placebo at either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol was administered 4 hours after the intervention. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment).
    Reporting group title
    Total Population
    Reporting group description
    Participants were randomized to receive 1 of 3 dose strengths of montelukast or 1 dose strength of placebo at either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol was administered 4 hours after the intervention. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment).
    Reporting group title
    Total Population
    Reporting group description
    Participants were randomized to receive 1 of 3 dose strengths of montelukast or 1 dose strength of placebo at either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol was administered 4 hours after the intervention. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment).
    Reporting group title
    Total Population
    Reporting group description
    Participants were randomized to receive 1 of 3 dose strengths of montelukast or 1 dose strength of placebo at either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol was administered 4 hours after the intervention. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment).
    Reporting group title
    Total Population
    Reporting group description
    Participants were randomized to receive 1 of 3 dose strengths of montelukast or 1 dose strength of placebo at either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol was administered 4 hours after the intervention. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment).
    Reporting group title
    Total Population
    Reporting group description
    Participants were randomized to receive 1 of 3 dose strengths of montelukast or 1 dose strength of placebo at either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol was administered 4 hours after the intervention. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment).
    Reporting group title
    Total Population
    Reporting group description
    Participants were randomized to receive 1 of 3 dose strengths of montelukast or 1 dose strength of placebo at either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol was administered 4 hours after the intervention. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment).

    Subject analysis set title
    Montelukast+Albuterol
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Montelukast (data for each participant are pooled across all 3 of the active doses received by that participant) + Albuterol (data for each participant are pooled across all 3 administrations of active albuterol, as added to active montelukast)

    Subject analysis set title
    Montelukast+Placebo
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Montelukast (data for each participant are pooled across all 3 of the active doses received by that participant) + Placebo for albuterol (data for each participant are pooled across all 3 administrations of placebo for albuterol, as added to active montelukast)

    Subject analysis set title
    Placebo
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants were randomized to receive placebo for montelukast on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol was administered 4 hours after placebo for montelukast. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment).

    Subject analysis set title
    25 mcg Montelukast
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants were randomized to receive montelukast 25 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol was administered 4 hours after montelukast. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment).

    Subject analysis set title
    100 mcg Montelukast
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants were randomized to receive montelukast 100 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol was administered 4 hours after montelukast. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment).

    Subject analysis set title
    250 mcg Montelukast
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants were randomized to receive montelukast 250 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol was administered 4 hours after montelukast. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment).

    Subject analysis set title
    500 mcg Montelukast
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants were randomized to receive montelukast 500 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol was administered 4 hours after montelukast. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment).

    Subject analysis set title
    1000 mcg Montelukast
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants were randomized to receive montelukast 1000 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol was administered 4 hours after montelukast. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment).

    Primary: Change from baseline in FEV1 over 4 hours

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    End point title
    Change from baseline in FEV1 over 4 hours
    End point description
    FEV1 measurements taken at 0 (=baseline), 10, 20, 30, 45, 60, 120, 180 and 240 minutes contributed to the average change from baseline over 4 hours. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement.
    End point type
    Primary
    End point timeframe
    0 (=baseline) to 4 hours after treatment with montelukast
    End point values
    Placebo 25 mcg Montelukast 100 mcg Montelukast 250 mcg Montelukast 500 mcg Montelukast 1000 mcg Montelukast
    Number of subjects analysed
    67 [1]
    42 [2]
    30 [3]
    66 [4]
    25 [5]
    36 [6]
    Units: liters
        least squares mean (confidence interval 95%)
    0.03 (-0.03 to 0.1)
    0.07 (0 to 0.14)
    0.13 (0.06 to 0.2)
    0.1 (0.04 to 0.16)
    0.09 (0.01 to 0.16)
    0.12 (0.05 to 0.19)
    Notes
    [1] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data.
    [2] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data.
    [3] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data.
    [4] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data.
    [5] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data.
    [6] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data.
    Statistical analysis title
    Montelukast 25 mcg vs. Placebo
    Statistical analysis description
    Difference in least squares (LS) means of time-weighted average change from baseline in FEV1 over 4 hours - Montelukast 25 mcg vs. Placebo. Based on a mixed-effects model with terms for treatment (including dose of montelukast), period and baseline FEV1.
    Comparison groups
    25 mcg Montelukast v Placebo
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.096
    Method
    Mixed models analysis
    Parameter type
    Mean difference in least squares
    Point estimate
    0.04
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.01
         upper limit
    0.08
    Statistical analysis title
    Montelukast 100 mcg vs. Placebo
    Statistical analysis description
    Difference in LS means of time-weighted average change from baseline in FEV1 over 4 hours - Montelukast 100 mcg vs. Placebo. Based on a mixed-effects model with terms for treatment (including dose of montelukast), period and baseline FEV1.
    Comparison groups
    100 mcg Montelukast v Placebo
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    ≤ 0.001
    Method
    Mixed models analysis
    Parameter type
    Mean difference in least squares
    Point estimate
    0.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.04
         upper limit
    0.15
    Statistical analysis title
    Montelukast 250 mcg vs. Placebo
    Statistical analysis description
    Difference in LS means of time-weighted average change from baseline in FEV1 over 4 hours - Montelukast 250 mcg vs. Placebo. Based on a mixed-effects model with terms for treatment (including dose of montelukast), period and baseline FEV1.
    Comparison groups
    250 mcg Montelukast v Placebo
    Number of subjects included in analysis
    133
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.002
    Method
    Mixed models analysis
    Parameter type
    Mean difference in least squares
    Point estimate
    0.06
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.02
         upper limit
    0.11
    Statistical analysis title
    Montelukast 500 mcg vs. Placebo
    Statistical analysis description
    Difference in LS means of time-weighted average change from baseline in FEV1 over 4 hours - Montelukast 500 mcg vs. Placebo. Based on a mixed-effects model with terms for treatment (including dose of montelukast), period and baseline FEV1.
    Comparison groups
    500 mcg Montelukast v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.081
    Method
    Mixed models analysis
    Parameter type
    Mean difference in least squares
    Point estimate
    0.05
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.01
         upper limit
    0.11
    Statistical analysis title
    Montelukast 1000 mcg vs. Placebo
    Statistical analysis description
    Difference in LS means of time-weighted average change from baseline in FEV1 over 4 hours - Montelukast 1000 mcg vs. Placebo. Based on a mixed-effects model with terms for treatment (including dose of montelukast), period and baseline FEV1.
    Comparison groups
    1000 mcg Montelukast v Placebo
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    ≤ 0.001
    Method
    Mixed models analysis
    Parameter type
    Mean difference in least squares
    Point estimate
    0.08
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.04
         upper limit
    0.13

    Secondary: Change from baseline in FEV1 over 90 minutes after albuterol/placebo administration

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    End point title
    Change from baseline in FEV1 over 90 minutes after albuterol/placebo administration
    End point description
    FEV1 measurements taken at 0 (=baseline), 15, 30, 60, and 90 minutes after albuterol/placebo administration contributed to the average change from baseline over 90 minutes. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement.
    End point type
    Secondary
    End point timeframe
    4 hours (equals time point at which albuterol or albuterol placebo is administered) to 5.5 hours after treatment with montelukast
    End point values
    Montelukast+Albuterol Montelukast+Placebo
    Number of subjects analysed
    26 [7]
    41 [8]
    Units: liters
        least squares mean (confidence interval 95%)
    0.34 (0.22 to 0.45)
    0.15 (0.06 to 0.24)
    Notes
    [7] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data.
    [8] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data.
    Statistical analysis title
    Difference in LS means
    Statistical analysis description
    Difference in LS means of time-weighted average change from baseline in FEV1 over 90 minutes after anbuterol/placebo administration - Montelukast+Albuterol vs. Montelukast+Placebo. Based on a repeated measures model with terms for treatment (albuterol/placebo), dose, treatment-by-dose interaction and baseline FEV1.
    Comparison groups
    Montelukast+Placebo v Montelukast+Albuterol
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.015
    Method
    Repeated measures model
    Parameter type
    Mean difference in least squares
    Point estimate
    0.19
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.04
         upper limit
    0.34

    Other pre-specified: Change from baseline in FEV1 at 8 hours after treatment with montelukast

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    End point title
    Change from baseline in FEV1 at 8 hours after treatment with montelukast
    End point description
    Average change from baseline in FEV1 at 8 hours after single dose montelukast administration.
    End point type
    Other pre-specified
    End point timeframe
    0 (baseline) and 8 hours after treatment with montelukast
    End point values
    Placebo 25 mcg Montelukast 100 mcg Montelukast 250 mcg Montelukast 500 mcg Montelukast 1000 mcg Montelukast
    Number of subjects analysed
    67 [9]
    42 [10]
    30 [11]
    66 [12]
    24 [13]
    35 [14]
    Units: liters
        least squares mean (confidence interval 95%)
    0.06 (-0.02 to 0.14)
    0.11 (0.03 to 0.2)
    0.13 (0.04 to 0.23)
    0.11 (0.03 to 0.19)
    0.12 (0.02 to 0.22)
    0.14 (0.05 to 0.23)
    Notes
    [9] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data.
    [10] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data.
    [11] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data.
    [12] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data.
    [13] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data.
    [14] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data.
    Statistical analysis title
    Montelukast 25 mcg vs. Placebo
    Statistical analysis description
    Difference in LS means for change from baseline in FEV1 at 8 hours after montelukast administration - Montelukast 25 mcg vs. Placebo. Based on a mixed-effects model with terms for treatment (including dose of montelukast), period and baseline FEV1.
    Comparison groups
    25 mcg Montelukast v Placebo
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.099
    Method
    Mixed models analysis
    Parameter type
    Mean difference in least squares
    Point estimate
    0.06
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.01
         upper limit
    0.12
    Statistical analysis title
    Montelukast 100 mcg vs. Placebo
    Statistical analysis description
    Difference in LS means for change from baseline in FEV1 at 8 hours after montelukast administration - Montelukast 100 mcg vs. Placebo. Based on a mixed-effects model with terms for treatment (including dose of montelukast), period and baseline FEV1.
    Comparison groups
    100 mcg Montelukast v Placebo
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.055
    Method
    Mixed models analysis
    Parameter type
    Mean difference in least squares
    Point estimate
    0.07
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0
         upper limit
    0.15
    Statistical analysis title
    Montelukast 250 mcg vs. Placebo
    Statistical analysis description
    Difference in LS means for change from baseline in FEV1 at 8 hours after montelukast administration - Montelukast 250 mcg vs. Placebo. Based on a mixed-effects model with terms for treatment (including dose of montelukast), period and baseline FEV1.
    Comparison groups
    250 mcg Montelukast v Placebo
    Number of subjects included in analysis
    133
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.097
    Method
    Mixed models analysis
    Parameter type
    Mean difference in least squares
    Point estimate
    0.05
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.01
         upper limit
    0.11
    Statistical analysis title
    Montelukast 500 mcg vs. Placebo
    Statistical analysis description
    Difference in LS means for change from baseline in FEV1 at 8 hours after montelukast administration - Montelukast 500 mcg vs. Placebo. Based on a mixed-effects model with terms for treatment (including dose of montelukast), period and baseline FEV1.
    Comparison groups
    500 mcg Montelukast v Placebo
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.175
    Method
    Mixed models analysis
    Parameter type
    Mean difference in least squares
    Point estimate
    0.06
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.03
         upper limit
    0.14
    Statistical analysis title
    Montelukast 1000 mcg vs. Placebo
    Statistical analysis description
    Difference in LS means for change from baseline in FEV1 at 8 hours after montelukast administration - Montelukast 1000 mcg vs. Placebo. Based on a mixed-effects model with terms for treatment (including dose of montelukast), period and baseline FEV1.
    Comparison groups
    1000 mcg Montelukast v Placebo
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.025
    Method
    Mixed models analysis
    Parameter type
    Mean difference in least squares
    Point estimate
    0.08
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.01
         upper limit
    0.15

    Other pre-specified: Change from baseline in FEV1 at 24 hours after treatment with montelukast

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    End point title
    Change from baseline in FEV1 at 24 hours after treatment with montelukast
    End point description
    Average change from baseline in FEV1 at 24 hours after single dose montelukast administration.
    End point type
    Other pre-specified
    End point timeframe
    0 (baseline) and 24 hours after treatment with montelukast
    End point values
    Placebo 25 mcg Montelukast 100 mcg Montelukast 250 mcg Montelukast 500 mcg Montelukast 1000 mcg Montelukast
    Number of subjects analysed
    67 [15]
    42 [16]
    29 [17]
    66 [18]
    25 [19]
    36 [20]
    Units: liters
        least squares mean (confidence interval 95%)
    0.02 (-0.06 to 0.09)
    0.05 (-0.03 to 0.13)
    0.1 (0.01 to 0.19)
    0.06 (-0.01 to 0.13)
    0.08 (-0.01 to 0.18)
    0.09 (0.01 to 0.18)
    Notes
    [15] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data.
    [16] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data.
    [17] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data.
    [18] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data.
    [19] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data.
    [20] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data.
    Statistical analysis title
    Montelukast 25 mcg vs. Placebo
    Statistical analysis description
    Difference in LS means in change from baseline in FEV1 at 24 hours after montelukast administration - Montelukast 25 mcg vs. Placebo. Based on mixed-effects model with terms for treatment (including dose of montelukast), period and baseline FEV1.
    Comparison groups
    25 mcg Montelukast v Placebo
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.25
    Method
    Mixed models analysis
    Parameter type
    Mean difference in least squares
    Point estimate
    0.04
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.03
         upper limit
    0.1
    Statistical analysis title
    Montelukast 100 mcg vs. Placebo
    Statistical analysis description
    Difference in LS means in change from baseline in FEV1 at 24 hours after montelukast administration - Montelukast 100 mcg vs. Placebo. Based on mixed-effects model with terms for treatment (including dose of montelukast), period and baseline FEV1.
    Comparison groups
    100 mcg Montelukast v Placebo
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.027
    Method
    Mixed models analysis
    Parameter type
    Mean difference in least squares
    Point estimate
    0.09
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.01
         upper limit
    0.17
    Statistical analysis title
    Montelukast 250 mcg vs. Placebo
    Statistical analysis description
    Difference in LS means in change from baseline in FEV1 at 24 hours after montelukast administration - Montelukast 250 mcg vs. Placebo. Based on mixed-effects model with terms for treatment (including dose of montelukast), period and baseline FEV1.
    Comparison groups
    250 mcg Montelukast v Placebo
    Number of subjects included in analysis
    133
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.117
    Method
    Mixed models analysis
    Parameter type
    Mean difference in least squares
    Point estimate
    0.05
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.01
         upper limit
    0.1
    Statistical analysis title
    Montelukast 500 mcg vs. Placebo
    Statistical analysis description
    Difference in LS means in change from baseline in FEV1 at 24 hours after montelukast administration - Montelukast 500 mcg vs. Placebo. Based on mixed-effects model with terms for treatment (including dose of montelukast), period and baseline FEV1.
    Comparison groups
    500 mcg Montelukast v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.111
    Method
    Mixed models analysis
    Parameter type
    Mean difference in least squares
    Point estimate
    0.07
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.02
         upper limit
    0.15
    Statistical analysis title
    Montelukast 1000 mcg vs. Placebo
    Statistical analysis description
    Difference in LS means in change from baseline in FEV1 at 24 hours after montelukast administration - Montelukast 1000 mcg vs. Placebo. Based on mixed-effects model with terms for treatment (including dose of montelukast), period and baseline FEV1.
    Comparison groups
    1000 mcg Montelukast v Placebo
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.026
    Method
    Mixed models analysis
    Parameter type
    Mean difference in least squares
    Point estimate
    0.08
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.01
         upper limit
    0.15

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 4 weeks (Up to 1 day after last dose of study drug)
    Adverse event reporting additional description
    The safety population consisted of all randomized participants who received at least one dose of study drug.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants were randomized to receive placebo for montelukast on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol was administered 4 hours after placebo for montelukast. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment).

    Reporting group title
    25 mcg Montelukast
    Reporting group description
    Participants were randomized to receive montelukast 25 mcg (microgram) on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol was administered 4 hours after montelukast 25 mcg. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment).

    Reporting group title
    100 mcg Montelukast
    Reporting group description
    Participants were randomized to receive montelukast 100 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol was administered 4 hours after montelukast 100 mcg. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment).

    Reporting group title
    250 mcg Montelukast
    Reporting group description
    Participants were randomized to receive montelukast 250 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol was administered 4 hours after montelukast 250 mcg. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment).

    Reporting group title
    500 mcg Montelukast
    Reporting group description
    Participants were randomized to receive montelukast 500 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol was administered 4 hours after montelukast 500 mcg. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment).

    Reporting group title
    1000 mcg Montelukast
    Reporting group description
    Participants were randomized to receive montelukast 1000 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol was administered 4 hours after montelukast 1000 mcg. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment).

    Serious adverse events
    Placebo 25 mcg Montelukast 100 mcg Montelukast 250 mcg Montelukast 500 mcg Montelukast 1000 mcg Montelukast
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 41 (0.00%)
    0 / 30 (0.00%)
    0 / 66 (0.00%)
    0 / 25 (0.00%)
    0 / 36 (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
    Placebo 25 mcg Montelukast 100 mcg Montelukast 250 mcg Montelukast 500 mcg Montelukast 1000 mcg Montelukast
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 67 (5.97%)
    1 / 41 (2.44%)
    0 / 30 (0.00%)
    3 / 66 (4.55%)
    3 / 25 (12.00%)
    0 / 36 (0.00%)
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 41 (0.00%)
    0 / 30 (0.00%)
    0 / 66 (0.00%)
    1 / 25 (4.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Excoriation
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 41 (0.00%)
    0 / 30 (0.00%)
    0 / 66 (0.00%)
    1 / 25 (4.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 41 (0.00%)
    0 / 30 (0.00%)
    0 / 66 (0.00%)
    0 / 25 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Sinus congestion
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 41 (2.44%)
    0 / 30 (0.00%)
    0 / 66 (0.00%)
    0 / 25 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Cough
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 41 (0.00%)
    0 / 30 (0.00%)
    0 / 66 (0.00%)
    0 / 25 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 41 (0.00%)
    0 / 30 (0.00%)
    1 / 66 (1.52%)
    0 / 25 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 41 (0.00%)
    0 / 30 (0.00%)
    0 / 66 (0.00%)
    1 / 25 (4.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Infections and infestations
    Gastroenteritis viral
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 41 (0.00%)
    0 / 30 (0.00%)
    1 / 66 (1.52%)
    0 / 25 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 41 (0.00%)
    0 / 30 (0.00%)
    0 / 66 (0.00%)
    1 / 25 (4.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 41 (0.00%)
    0 / 30 (0.00%)
    1 / 66 (1.52%)
    0 / 25 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    Viral infection
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 41 (0.00%)
    0 / 30 (0.00%)
    0 / 66 (0.00%)
    0 / 25 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 41 (0.00%)
    0 / 30 (0.00%)
    0 / 66 (0.00%)
    0 / 25 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0

    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
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