Exercise Induced Bronchoconstriction (EIB) MedDRA version: 9.1 Level: LLT Classification code 10006464 Term: Bronchoconstriction
Conditions
Interventions
Trade Name: SINGULAIR
Product Name: SINGULAIR (Montelukast sodium)
Product Code: MK-0476
Pharmaceutical Form: Chewable tablet
INN or Proposed INN: Montelukast sodium
CAS Number: 158966-92-8
Concentrat
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The child is 4 years to 14 years of age. The child has exercise-induced bronchoconstriction (EIB) with or without a diagnosis of persistent asthma. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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. The child is hypersensitive to inhaled ß-agonist or montelukast.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of a single oral dose of montelukast, compared with placebo, on EIB as measured by the maximal percent fall in FEV1 (post-exercise change from pre-exercise baseline) after exercise challenge performed 2 hours post-dose.;Secondary Objective: 1. To determine the effect of a single oral dose of montelukast, compared with placebo, on: a. The maximal percent fall in FEV1 (post-exercise change from pre-exercise baseline) following exercise challenge performed 24 hours post-dose, b. The categorized maximum percent fall in FEV1 (20%) following exercise challenges performed 2 and 24 hours post-dose. c. The area under the curve for the percent-fall from pre-exercise FEV1 over time (AUC0-60 min) following exercise challenges performed 2 and 24 hours post-dose, d. Time to recovery of FEV1 to within 5% of baseline following exercise challenges performed 2 and 24 hours post-dose, and e. Need for rescue medication following exercise challenges performed 2 and 24 hours post-dose. 2. Montelukast will be well tolerated in patients with EIB. ;Primary end point(s): The principle efficacy measurement in this study is the maximum percent fall from pre-exercise baseline in FEV1. Additional efficacy measurements include AUC0-60 min and time to recovery of FEV1 to within 5% of baseline, all of which are derived from spirometry measurements at study visits. The proportion of patients requiring rescue with short-acting beta-agonist within the 90 minutes following exercise will also be assessed. | — |
Countries
Estonia
Outcome results
None listed