Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Exercise induced bronchoconstriction in children – a single dose of montelukast as alternative to regular daily doses.

    Summary
    EudraCT number
    		 2011-003652-39
    Trial protocol
    		 DK  
    Global end of trial date
    26 Aug 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Feb 2023
    First version publication date
    14 Feb 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    30689
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Non-Commercial
    Sponsor organisation address
    Palle Juul- Jensens Boulevard 99, Aarhus N, Denmark, 8200
    Public contact
    Karen Schow Jensen, Karen Schow Jensen, +45 61718432, karenschowjensen@gmail.com
    Scientific contact
    Karen Schow Jensen, Karen Schow Jensen, 61718432 61718432, karenschowjensen@gmail.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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 May 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Aug 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Aug 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study will compare the effect of a single dose of montelukast and regular daily use of montelukast in children with exercise induced bronchoconstriction. Breathing will be measured by a spirometer before exercising and measured again several times after exercising.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards. Patients could receive an inhaled short-acting beta-agonist for distressing symptoms during or after exercise challenge at the discretion of the investigator.
    Background therapy
    		 Background medicine: inhaled corticosteroid therapy (equivalent to max 400-800mikg budesonide daily or equipotent doses).
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2013
    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
    Denmark: 19
    Worldwide total number of subjects
    19
    EEA total number of subjects
    19
    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)
    7
    Adolescents (12-17 years)
    12
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Screening criteria: Proven exercise-induced asthma with a decrease in FEV1 of >12% Number of subjects screened: 44 Subjects were excluded during screening because they did not prove to have exercise-induced asthma with a decrease in FEV1 of >12% at the screening test

    Pre-assignment period milestones
    Number of subjects started
    		 19
    Number of subjects completed
    		 19

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Placebo
    Arm description
    		 Subjects were randomised to receive placebo for 7 days in the evening and a morning placebo dose the last day in treatment period 1 or treatment period 2 or treatment period 3 in a counterbalanced order.
    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
    Placebo: placebo 7 days in the evening and a morning placebo dose the last day

    Arm title
    		 Single dose of montelukast
    Arm description
    		 Subjects were randomised to receive placebo for 7 days in the evening and a morning single dose of montelukast the last day in treatment period 1 or treatment period 2 or treatment period 3 in a counterbalanced order.
    Arm type
    		 Experimental

    Investigational medicinal product name
    montelukast, single
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Single dose of montelukast: placebo 7 days in the evening and a morning dose of montelukast the last day

    Arm title
    		 Montelukast
    Arm description
    		 Subjects were randomised to receive montelukast for 7 days in the evening and a morning dose of placebo the last day in treatment period 1 or treatment period 2 or treatment period 3 in a counterbalanced order.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Montelukast: Montelukast 7 days in the evening and a morning placebo dose the last day

    Number of subjects in period 1
    		Placebo Single dose of montelukast Montelukast
    Started
    19
    19
    19
    Completed
    19
    19
    19

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Period 1
    Reporting group description
    		 -

    Reporting group values
    		 Period 1 Total
    Number of subjects
    		 19 19
    Age categorical
    Since the design is crossover, there are 19 participants in each group, but the total number of participants is also 19.
    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)
    		 7 7
        Adolescents (12-17 years)
    		 12 12
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Since the design is crossover, there are 19 participants in each group, but the total number of participants is also 19.
    Units: Subjects
        Female
    		 5 5
        Male
    		 14 14
    Subject analysis sets

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Completers analysis population included all randomized participants who received the study drug in all three periods

    Subject analysis set title
    Single dose Montelukast
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Completers analysis population included all randomized participants who received the study drug in all three periods

    Subject analysis set title
    Montelukast
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Completers analysis population included all randomized participants who received the study drug in all three periods

    Subject analysis sets values
    		 Placebo Single dose Montelukast Montelukast
    Number of subjects
    19
    19
    19
    Age categorical
    Since the design is crossover, there are 19 participants in each group, but the total number of participants is also 19.
    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)
    7
    7
    7
        Adolescents (12-17 years)
    12
    12
    12
        Adults (18-64 years)
    0
    0
    0
        From 65-84 years
    0
    0
    0
        85 years and over
    0
    0
    0
    Age continuous
    Units:
        
    ( )
    ( )
    ( )
    Gender categorical
    Since the design is crossover, there are 19 participants in each group, but the total number of participants is also 19.
    Units: Subjects
        Female
    5
    5
    5
        Male
    14
    14
    14

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were randomised to receive placebo for 7 days in the evening and a morning placebo dose the last day in treatment period 1 or treatment period 2 or treatment period 3 in a counterbalanced order.

    Reporting group title
    Single dose of montelukast
    Reporting group description
    		 Subjects were randomised to receive placebo for 7 days in the evening and a morning single dose of montelukast the last day in treatment period 1 or treatment period 2 or treatment period 3 in a counterbalanced order.

    Reporting group title
    Montelukast
    Reporting group description
    		 Subjects were randomised to receive montelukast for 7 days in the evening and a morning dose of placebo the last day in treatment period 1 or treatment period 2 or treatment period 3 in a counterbalanced order.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Completers analysis population included all randomized participants who received the study drug in all three periods

    Subject analysis set title
    Single dose Montelukast
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Completers analysis population included all randomized participants who received the study drug in all three periods

    Subject analysis set title
    Montelukast
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Completers analysis population included all randomized participants who received the study drug in all three periods

    Primary: Maximum Percent Fall in FEV1 After Exercise Challenge at 2 Hours Postdose

    		 Close Top of page
    End point title
    		 Maximum Percent Fall in FEV1 After Exercise Challenge at 2 Hours Postdose
    End point description
    Maximum Percent Fall in FEV1 was defined as the % change from pre-exercise baseline FEV1 to the lowest FEV1 within 20 minutes after exercise. Spirometry measurements were taken prior to each exercise challenge and immediately, 3, 5, 10, 15, & 20 minutes after each exercise challenge. The 2-hour exercise challenges occurred 2 hours after the last dose of study medication. The calculation used to produce the results was [100*(1-(X/Y))] where X= the lowest FEV1 within 20 mins after exercise & Y= pre-exercise baseline FEV1.
    End point type
    Primary
    End point timeframe
    Pre-exercise baseline and 0-20 minutes after the exercise challenge performed 2 hours post-dose
    End point values
    		 Placebo Single dose Montelukast Montelukast
    Number of subjects analysed
    19
    19
    19
    Units: FEV1 % change
        arithmetic mean (standard error)
    14.6 ( 2.4 )
    9.0 ( 1.6 )
    13.0 ( 2.8 )
    Statistical analysis title
    		 Comparison between single montelukast vs. placebo
    Comparison groups
    Placebo v Single dose Montelukast
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 11
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.6
    Notes
    [1] - Since the design is crossover, the total number of participants is 19.

    Primary: Maximum Percent Fall in FEV1 After Exercise Challenge at 5 Hours Postdose

    		 Close Top of page
    End point title
    		 Maximum Percent Fall in FEV1 After Exercise Challenge at 5 Hours Postdose
    End point description
    Maximum Percent Fall in FEV1 was defined as the % change from pre-exercise baseline FEV1 to the lowest FEV1 within 20 minutes after exercise. Spirometry measurements were taken prior to each exercise challenge and immediately, 3, 5, 10, 15, & 20 minutes after each exercise challenge. The 5-hour exercise challenges occurred 5 hours after the last dose of study medication. The calculation used to produce the results was [100*(1-(X/Y))] where X= the lowest FEV1 within 20 mins after exercise & Y= pre-exercise baseline FEV1.
    End point type
    Primary
    End point timeframe
    Pre-exercise baseline and 0-20 minutes after the exercise challenge performed 5 hours post-dose
    End point values
    		 Placebo Single dose Montelukast Montelukast
    Number of subjects analysed
    19
    19
    19
    Units: FEV1
        arithmetic mean (standard error)
    10.7 ( 2.4 )
    6.7 ( 1.4 )
    8.7 ( 1.9 )
    Statistical analysis title
    		 Comparison between single montelukast vs. placebo
    Comparison groups
    Placebo v Single dose Montelukast
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 9.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.7
    Notes
    [2] - Since the design is crossover, the total number of participants is 19.

    Primary: Maximum Percent Fall in FEV1 After Exercise Challenge at 8 Hours Postdose

    		 Close Top of page
    End point title
    		 Maximum Percent Fall in FEV1 After Exercise Challenge at 8 Hours Postdose
    End point description
    Maximum Percent Fall in FEV1 was defined as the % change from pre-exercise baseline FEV1 to the lowest FEV1 within 20 minutes after exercise. Spirometry measurements were taken prior to each exercise challenge and immediately, 3, 5, 10, 15, & 20 minutes after each exercise challenge. The 8-hour exercise challenges occurred 8 hours after the last dose of study medication. The calculation used to produce the results was [100*(1-(X/Y))] where X= the lowest FEV1 within 20 mins after exercise & Y= pre-exercise baseline FEV1.
    End point type
    Primary
    End point timeframe
    Pre-exercise baseline and 0-20 minutes after the exercise challenge performed 8 hours post-dose
    End point values
    		 Placebo Single dose Montelukast Montelukast
    Number of subjects analysed
    19
    19
    19
    Units: FEV1
        arithmetic mean (standard error)
    10.5 ( 2.1 )
    7.6 ( 1.4 )
    7.7 ( 1.8 )
    Statistical analysis title
    		 Comparison between single montelukast vs. placebo
    Comparison groups
    Placebo v Single dose Montelukast
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 6.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.8
    Notes
    [3] - Since the design is crossover, the total number of participants is 19.

    Primary: Maximum Percent Fall in FEV1 After Exercise Challenge at 11 Hours Postdose

    		 Close Top of page
    End point title
    		 Maximum Percent Fall in FEV1 After Exercise Challenge at 11 Hours Postdose
    End point description
    Maximum Percent Fall in FEV1 was defined as the % change from pre-exercise baseline FEV1 to the lowest FEV1 within 20 minutes after exercise. Spirometry measurements were taken prior to each exercise challenge and immediately, 3, 5, 10, 15, & 20 minutes after each exercise challenge. The 11-hour exercise challenges occurred 11 hours after the last dose of study medication. The calculation used to produce the results was [100*(1-(X/Y))] where X= the lowest FEV1 within 20 mins after exercise & Y= pre-exercise baseline FEV1.
    End point type
    Primary
    End point timeframe
    Pre-exercise baseline and 0-20 minutes after the exercise challenge performed11 hours post-dose
    End point values
    		 Placebo Single dose Montelukast Montelukast
    Number of subjects analysed
    19
    19
    19
    Units: FEV1
        arithmetic mean (standard error)
    12.9 ( 2.4 )
    11.1 ( 1.9 )
    8.4 ( 1.8 )
    Statistical analysis title
    		 Since the design is crossover, the total number of
    Comparison groups
    Single dose Montelukast v Placebo
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.2
         upper limit
    		 6.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.3
    Notes
    [4] - Since the design is crossover, the total number of participants is 19.

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Adverse events assessment at every visit
    Adverse event reporting additional description
    At every visit participants were interviewed about eventual adverse effect of the medicine. Participants were closely monitored for potential injuries in relation to exercise challenge tests.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    single dose montelukast
    Reporting group description
    		 -

    Reporting group title
    Montelukast
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo single dose montelukast Montelukast
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo single dose montelukast Montelukast
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 19 (21.05%)
    3 / 19 (15.79%)
    4 / 19 (21.05%)
    Nervous system disorders
    headache
         subjects affected / exposed
    2 / 19 (10.53%)
    0 / 19 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    2
    0
    1
    Gastrointestinal disorders
    stomach ache
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 19 (5.26%)
    2 / 19 (10.53%)
         occurrences all number
    1
    1
    2
    vomiting
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 19 (10.53%)
    0 / 19 (0.00%)
         occurrences all number
    0
    2
    0

    More information

    		 Close Top of page

    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
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Mon May 06 01:03:38 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA