Asthma MedDRA version: 8.0 Level: LLT Classification code 10003553
Conditions
Interventions
Trade Name: SINGULAIR
Product Name: montelukast sodium
Product Code: n/a
Pharmaceutical Form: Tablet
INN or Proposed INN: montelukast so
Sponsors
Merck Sharp & Dohme OÜ
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Consistent clinical history of asthma for at least 1 year 2. A forced expiratory volume in one second (FEV1) of = 70% of the predicted value 3. Exercise induced Bronchoconstriction showing a decrease in FEV1 of = 20% demonstrated twice in the Run-In Period. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patient is hospitalized 2. Patient has taken an excluded medication during the run-in period 3. Patient has ever been intubated, required acute asthma therapy within one month, or hospitalized for asthma within 3 months of visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ; Main Objective: 1. To determine the effects of montelukast + fluticasone vs. salmeterol + fluticasone on Exercise Induced Bronchoconstriction (EIB) as measured by maximum post exercise percent fall in FEV1 2. To measure the extent and severity of EIB as measured with AUC (0-20) 3. Safety and tolerability of daily treatment with montelukast vs. salmeterol ; Primary end point(s): • Maximum percent fall in FEV1 after exercise and before beta-agonist administration. • AUC 0-20 • Avg. percent change in FEV1 after beta-agonist intake. • Maximum FEV1 percent predicted following beta-agonist intake. • Time to recovery. | — |
Countries
Estonia, Italy, Spain
Outcome results
None listed