Montelukast in Exercise-Induced Bronchospasm - 2003

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092131
First received: September 21, 2004
Last updated: June 29, 2010
Last verified: June 2010
Results First Received: September 24, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Asthma, Exercise-Induced
Interventions: Drug: Comparator: Montelukast
Drug: Comparator: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Patients were randomized at 9 sites.

Primary therapy period: July to November 2003


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients who required excluded medications, or did not meet forced expiratory volume in 1 second (FEV1) criteria during the prestudy period were excluded from randomization. Patients who required a β-agonist after the exercise challenge and did not meet FEV1 criteria within 30 minutes of treatment were also excluded.

Reporting Groups
  Description
Montelukast 10 mg in Period I Then Placebo in Period II A montelukast 10-mg tablet (Treatment Period I) was taken orally as a single witnessed dose followed by a 3-7 day washout. Then a montelukast matching-image placebo tablet (Treatment Period II) was taken orally as a single witnessed dose.
Placebo in Period I Then Montelukast 10 mg in Period II A montelukast matching-image placebo tablet (Treatment Period I) was taken orally as a single witnessed dose followed by a 3-7 day washout. Then a montelukast 10-mg tablet (Treatment Period II) was taken orally as a single witnessed dose.

Participant Flow for 2 periods

Period 1:   Treatment Period I
    Montelukast 10 mg in Period I Then Placebo in Period II     Placebo in Period I Then Montelukast 10 mg in Period II  
STARTED     25 [1]   26  
COMPLETED     24     26  
NOT COMPLETED     1     0  
Adverse Event                 1                 0  
[1] 1 patient discontinued due to influenza which started in washout (11 days after Period I medication)

Period 2:   Treatment Period II
    Montelukast 10 mg in Period I Then Placebo in Period II     Placebo in Period I Then Montelukast 10 mg in Period II  
STARTED     24     26 [1]
COMPLETED     24     25  
NOT COMPLETED     0     1  
Adverse Event                 0                 1  
[1] 1 patient discontinued after taking Period II study medication, due to asthma exacerbation



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Overall Study Population All randomized patients

Baseline Measures
    Overall Study Population  
Number of Participants  
[units: participants]
  51  
Age  
[units: years]
Mean ± Standard Deviation
  24.5  ± 5.9  
Gender  
[units: participants]
 
Female     27  
Male     24  
Need for β-agonist rescue medication following exercise challenge  
[units: Participants]
 
No     47  
Yes     4  
AUC for percent change from pre-exercise measurement FEV1 in L 0-60 mins after exercise challenge [1]
[units: (percent change) *minutes]
Mean ± Standard Deviation
  762.59  ± 380.34  
Maximum Percent Fall in forced expiratory volume in 1 second (FEV1) post-exercise challenge [2]
[units: Percent change from pre-exercise measure]
Mean ± Standard Deviation
  27.63  ± 5.60  
Time to recovery from maximal percent fall in FEV1 after exercise challenge [3]
[units: Minutes]
Mean ± Standard Deviation
  45.15  ± 29.70  
[1] Area under the curve (AUC) for FEV1 percent change from pre-exercise measurement over the first hour after exercise challenge.
[2] Maximum percent fall in FEV1 from pre-exercise measurement occurring within the first 60 minutes after exercise challenge. Pre-exercise measurement FEV1 is the value (in liters) measured on the day of the exercise challenge, 5 minutes before exercise testing.
[3] The duration between the time at which the maximum percent fall in FEV1 occurs and the time when the FEV1 returns to within 5% of the pre-exercise measurement for the first time after the exercise challenge



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Percent Fall in FEV1 After Exercise Challenge at 2 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)   [ Time Frame: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose ]

2.  Secondary:   Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose   [ Time Frame: 0-90 minutes after the exercise challenge performed at 2 hours postdose ]

3.  Secondary:   Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 12 Hours Postdose   [ Time Frame: 0-90 minutes after the exercise challenge performed at 12 hours postdose ]

4.  Secondary:   Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose   [ Time Frame: 0-90 minutes after the exercise challenge performed at 24 hours postdose ]

5.  Secondary:   Maximum Percent Fall in FEV1 After Exercise Challenge at 12 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)   [ Time Frame: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 12 hours after a single oral dose ]

6.  Secondary:   Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)   [ Time Frame: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 24 hours after a single oral dose ]

7.  Secondary:   Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 2 Hours Postdose   [ Time Frame: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 2 hours postdose ]

8.  Secondary:   Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 12 Hours Postdose   [ Time Frame: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 12 hours postdose ]

9.  Secondary:   Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 24 Hours Postdose   [ Time Frame: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 24 hours postdose ]

10.  Secondary:   Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose   [ Time Frame: Exercise challenge at 2 hours postdose ]

11.  Secondary:   Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 12 Hours Postdose   [ Time Frame: Exercise challenge at 12 hours postdose ]

12.  Secondary:   Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose   [ Time Frame: Exercise challenge at 24 hours postdose ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372


Publications:

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00092131     History of Changes
Other Study ID Numbers: 2004_026, MK0476-270
Study First Received: September 21, 2004
Results First Received: September 24, 2009
Last Updated: June 29, 2010
Health Authority: United States: Food and Drug Administration