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Montelukast in Pediatric Allergic Asthma (0476-336)(COMPLETED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00289874
Recruitment Status : Completed
First Posted : February 10, 2006
Results First Posted : October 1, 2010
Last Update Posted : February 17, 2016
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: montelukast sodium
Drug: Comparator: Placebo
Enrollment 421
Recruitment Details

One hundred three sites in US;

Prime Therapy: March 2006 to July 2007

Pre-assignment Details Patients who had unresolved symptoms and signs of an upper respiratory tract infection between Visits 1 and 2, or had evidence of active, clinically significant sinus infection within 1 week of Visit 1 or between Visits 1 and 2, or failed to meet minimum requirement for daytime asthma symptoms and daily β-agonist use were excluded.
Arm/Group Title Montelukast 5 mg Placebo
Hide Arm/Group Description Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks. Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
Period Title: Overall Study
Started 203 218
Completed 197 210
Not Completed 6 8
Reason Not Completed
Adverse Event             1             5
Lost to Follow-up             1             1
Protocol Violation             3             2
Did not meet eligibility             1             0
Arm/Group Title Montelukast 5 mg Placebo Total
Hide Arm/Group Description Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks. Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks. Total of all reporting groups
Overall Number of Baseline Participants 203 218 421
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 203 participants 218 participants 421 participants
10.6  (2.4) 10.7  (2.4) 10.6  (2.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 203 participants 218 participants 421 participants
Female
81
  39.9%
90
  41.3%
171
  40.6%
Male
122
  60.1%
128
  58.7%
250
  59.4%
Daily β-agonist use  
Mean (Standard Deviation)
Unit of measure:  Puffs/Day
Number Analyzed 203 participants 218 participants 421 participants
3.01  (1.77) 2.72  (1.68) 2.86  (1.73)
Forced expiratory volume in 1 second (FEV1)  
Mean (Standard Deviation)
Unit of measure:  Liters
Number Analyzed 203 participants 218 participants 421 participants
1.81  (0.57) 1.84  (0.60) 1.83  (0.58)
1.Primary Outcome
Title Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3
Hide Description Percent change from baseline in FEV1, a measure of airway function, at Week 3
Time Frame Baseline and week 3
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set population (i.e., includes all patients who had baseline and on-treatment measurements).
Arm/Group Title Montelukast 5 mg Placebo
Hide Arm/Group Description:
Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.
Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
Overall Number of Participants Analyzed 199 208
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change
9.53
(7.05 to 12.01)
9.15
(6.71 to 11.59)
2.Secondary Outcome
Title Percent Change From Baseline in Mean Daily "as Needed" β-agonist Use Over the 3-week Treatment Period
Hide Description Percent change from baseline in average daily β-agonist use over the 3-week treatment period
Time Frame Baseline and Week 3
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set population (i.e., includes all patients who had baseline and on-treatment measurements).
Arm/Group Title Montelukast 5 mg Placebo
Hide Arm/Group Description:
Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.
Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
Overall Number of Participants Analyzed 198 212
Median (Standard Deviation)
Unit of Measure: Percent Change
-18.88  (84.75) -12.40  (53.88)
Time Frame Adverse events (AEs) were collected during the 6 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
Adverse Event Reporting Description

The number of participants listed in the SAE table (203 montelukast & 217 placebo) is the number that received treatment.

Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.

 
Arm/Group Title Montelukast 5 mg Placebo
Hide Arm/Group Description Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks. Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
All-Cause Mortality
Montelukast 5 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Montelukast 5 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/203 (0.00%)   4/217 (1.84%) 
Injury, poisoning and procedural complications     
Femur fracture * 1  0/203 (0.00%)  1/217 (0.46%) 
Overdose * 1  0/203 (0.00%)  1/217 (0.46%) 
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  0/203 (0.00%)  2/217 (0.92%) 
Respiratory distress * 1  0/203 (0.00%)  1/217 (0.46%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Montelukast 5 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/203 (0.00%)   0/217 (0.00%) 
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.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00289874    
Other Study ID Numbers: 0476-336
2006_001
First Submitted: February 7, 2006
First Posted: February 10, 2006
Results First Submitted: September 9, 2009
Results First Posted: October 1, 2010
Last Update Posted: February 17, 2016