Phase 4
N=66
The Effect of Montelukast on Difficulty in Breathing After Exercise in Pediatric Patients (MK0476-377)(COMPLETED)
Exercise-induced Bronchoconstriction (EIB)
Bottom Line
View on ClinicalTrials.gov: NCT00534976 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Apr 2011
Primary outcome: Primary: Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Postdose — 15.35; 20.00 Percent fall in FEV1 — p=0.020
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Comparator: montelukast sodium (Drug); Comparator: Comparator: placebo (unspecified) (Drug)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Postdose |
15.35; 20.00 | 0.020 sig |
| SECONDARY Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose |
12.96; 17.22 | 0.005 sig |
| 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 |
294.50; 415.37 | 0.022 sig |
| 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 |
229.19; 349.59 | 0.013 sig |
| SECONDARY Time to Recovery From Maximum Percent Fall in FEV1 at 2 Hours Post-dose |
16.21; 24.48 | 0.064 |
| SECONDARY Time to Recovery From Maximum Percent Fall in FEV1 at 24 Hours Post-dose |
11.58; 18.46 | 0.054 |
| SECONDARY Number of Participants Requiring Rescue Medication at 2 Hours Postdose |
1; 2 | 1.000 |
| SECONDARY Number of Participants Requiring Rescue Medication at 24 Hours Postdose |
0; 2 | — |
Summary
This study will see if there is a change in breathing after exercising when the child receives study drug ( montelukast or placebo). Breathing will be measured by a spirometer before exercising and measured again several times after exercising.
Eligibility Criteria
Inclusion Criteria
- The child is 4 years to 14 years of age
- The child is a non smoker
- The child has exercise-induced bronchoconstriction (EIB)
Exclusion Criteria
- The child has active or chronic breathing disease, other than asthma
- The child has required insertion of a breathing tube for asthma
- The child had major surgery within the last 4 weeks
- The child is currently in the hospital
- The child has or had an upper respiratory tract infection within the last 2 weeks
- The child has been hospitalized or visited the emergency room or had a change in their medication for asthma within the last 4 weeks
- The child has been in a research study in the last 4 weeks
- The child has stomach, brain, heart, kidney or liver disease
- The child drinks more that 4 caffeinated drinks a day
Data sourced from ClinicalTrials.gov (NCT00534976). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.