The Effect of Montelukast on Difficulty in Breathing After Exercise in Pediatric Patients (MK0476-377)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00534976
First received: September 21, 2007
Last updated: June 30, 2014
Last verified: June 2014
Results First Received: March 11, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Exercise-induced Bronchoconstriction (EIB)
Interventions: Drug: Comparator: montelukast sodium
Drug: Comparator: Comparator: placebo (unspecified)

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 364 participants screened for inclusion, 298 participants were excluded during screening and were not randomized. The remaining 66 participants met inclusion criteria and were randomly allocated to one of the two treatment sequences.

Reporting Groups
  Description
Montelukast/ Placebo In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. In Period II, participants 4-5 years of age were randomized to receive one Montelukast 4-mg chewable tablet (single dose). Period III was the crossover to one matching placebo 4-mg chewable tablet (single dose) after a 3- to 7-day washout period. No participants 4-5 years of age were randomized, so the 4-mg doses were not dispensed. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II, crossing over to one matching placebo 5-mg chewable tablet (single dose) in Period III after a 3- to 7-day washout period.
Placebo/ Montelukast In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. In Period II, participants 4-5 years of age were randomized to receive one placebo 4-mg chewable tablet (single dose). Period III was the crossover to one Montelukast 4-mg chewable tablet (single dose) after a 3- to 7-day washout period. No participants 4-5 years of age were randomized, so the 4-mg doses were not dispensed. Participants 6-14 years of age were randomized to receive one placebo 5-mg chewable tablet (single dose) in Period II, crossing over to one Montelukast 5-mg chewable tablet (single dose) in Period III after a 3- to 7-day washout period.

Participant Flow for 3 periods

Period 1:   Period 1: Placebo Run-in
    Montelukast/ Placebo     Placebo/ Montelukast  
STARTED     33     33  
COMPLETED     33     33  
NOT COMPLETED     0     0  

Period 2:   Period 2: Treatment Montelukast/ Placebo
    Montelukast/ Placebo     Placebo/ Montelukast  
STARTED     33     33  
COMPLETED     33     32  
NOT COMPLETED     0     1  
Protocol Violation                 0                 1  

Period 3:   Period 3: Crossover Placebo/ Montelukast
    Montelukast/ Placebo     Placebo/ Montelukast  
STARTED     33     32  
COMPLETED     31     32  
NOT COMPLETED     2     0  
Physician Decision                 1                 0  
Withdrawal by Subject                 1                 0  



  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.
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Reporting Groups
  Description
Montelukast/ Placebo In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. In Period II, participants 4-5 years of age were randomized to receive one Montelukast 4-mg chewable tablet (single dose). Period III was the crossover to one matching placebo 4-mg chewable tablet (single dose) after a 3- to 7-day washout period. No participants 4-5 years of age were randomized, so the 4-mg doses were not dispensed. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II, crossing over to one matching placebo 5-mg chewable tablet (single dose) in Period III after a 3- to 7-day washout period.
Placebo/ Montelukast In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. In Period II, participants 4-5 years of age were randomized to receive one placebo 4-mg chewable tablet (single dose). Period III was the crossover to one Montelukast 4-mg chewable tablet (single dose) after a 3- to 7-day washout period. No participants 4-5 years of age were randomized, so the 4-mg doses were not dispensed. Participants 6-14 years of age were randomized to receive one placebo 5-mg chewable tablet (single dose) in Period II, crossing over to one Montelukast 5-mg chewable tablet (single dose) in Period III after a 3- to 7-day washout period.
Total Total of all reporting groups

Baseline Measures
    Montelukast/ Placebo     Placebo/ Montelukast     Total  
Number of Participants  
[units: participants]
  33     33     66  
Age  
[units: years]
Mean ± Standard Deviation
  10.9  ± 2.3     11.5  ± 1.8     11.2  ± 2.1  
Gender  
[units: participants]
     
Female     14     15     29  
Male     19     18     37  



  Outcome Measures
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1.  Primary:   Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Postdose   [ Time Frame: Pre-exercise baseline and 0-60 minutes after the exercise challenge performed 2 hours post-dose ]

2.  Secondary:   Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose   [ Time Frame: Pre-exercise baseline and 0-60 minutes after the exercise challenge performed 24 hours post-dose ]

3.  Secondary:   Area Under the Curve for FEV1 Percent Fall From Pre-exercise Baseline to 60 Minutes Following Exercise Challenge (AUC0-60 Min) at 2 Hours Post-dose   [ Time Frame: Pre-exercise baseline to 60 minutes after the exercise challenge performed 2 hours post-dose ]

4.  Secondary:   Area Under the Curve for FEV1 Percent Fall From Pre-exercise Baseline to 60 Minutes Following Exercise Challenge (AUC0-60 Min) at 24 Hours Post-dose   [ Time Frame: Pre-exercise baseline to 60 minutes after the exercise challenge performed 24 hours post-dose ]

5.  Secondary:   Time to Recovery From Maximum Percent Fall in FEV1 at 2 Hours Post-dose   [ Time Frame: 0-60 minutes and 0-90 minutes after the exercise challenge at 2 hours postdose ]

6.  Secondary:   Time to Recovery From Maximum Percent Fall in FEV1 at 24 Hours Post-dose   [ Time Frame: 0-60 minutes and 0-90 minutes after the exercise challenge at 24 hours postdose ]

7.  Secondary:   Number of Participants Requiring Rescue Medication at 2 Hours Postdose   [ Time Frame: 0-90 minutes after the exercise challenge at 2 hours postdose ]

8.  Secondary:   Number of Participants Requiring Rescue Medication at 24 Hours Postdose   [ Time Frame: 0-90 minutes after the exercise challenge at 24 hours postdose ]


  Serious Adverse Events
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Time Frame No text entered.
Additional Description The analysis of safety data was carried out using an all patients as treated (APaT) population. This population included all randomized patients who received at least one dose of study treatment.

Reporting Groups
  Description
Montelukast In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
Placebo In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.

Serious Adverse Events
    Montelukast     Placebo  
Total, serious adverse events      
# participants affected / at risk     0/33 (0.00%)     0/33 (0.00%)  




  Other Adverse Events


  Limitations and Caveats
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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
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  More Information