episodic or intermittent asthma MedDRA version: 8.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Trade Name: SINGULAIR
Product Name: montelukast sodium
Product Code: N/A
Pharmaceutical Form: Chewable tablet
INN or Proposed INN: monte
Sponsors
Suomen MSD Oy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is a male or female between the ages of 2 years (24 months) and 5 years (71 months) inclusive. 2. Patient has a history of episodic asthma symptoms such that in the 12 months prior to Visit 1, patient had at least 3, but not more than 6, episodes of asthma symptoms (e.g., cough, wheeze, shortness of breath) for approximately 3 days, each involving ß-agonist treatment, AND one of these episodes occurred within 6 months of Visit 1, AND episodes are separated in time by periods without asthma symptoms (may be obtained as verbal medical history from parent/guardian). 3. In the 12 months prior to Visit 1, patient had at least 1 corticosteroid treatment (oral, rectal, or inhaled) OR was hospitalized for asthma at least 1 time (may be obtained as verbal medical history from parent/guardian). 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 has a history of persistent asthma symptoms such that daytime symptoms occur >1 time per week and nighttime symptoms occur >2 times per month. 2. Patient has used any long-term controller medications (inhaled corticosteroids, leukotriene modifiers, cromolyn/nedocromil or theophylline) in the past 2 weeks or for greater than or equal to 4 months, cumulatively, in the 12 months prior to Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the regimen-related efficacy of montelukast (daily dosing and intermittent, episode-driven dosing) compared with placebo in decreasing the number of asthma episodes culminating in asthma attack over a 1-year treatment period.;Secondary Objective: To investigate, over a 1-year treatment period, the regimen-related efficacy of montelukast (daily dosing and intermittent, episode-driven dosing) compared with placebo in improving: the respiratory symptoms (daily average mean of wheeze and difficulty breathing) assessed over 3 days prior to asthma attacks; or the respiratory symptoms (daily average mean of wheeze, difficulty breathing, interference with activity and cough) assessed during the 12-day treatment period of asthma episodes; and to compare the regimen-related safety profile of montelukast (daily dosing and intermittent, episode-driven dosing) with placebo over the 1-year treatment period.; Primary end point(s): The primary endpoint is the number of asthma episodes culminating in asthma attack. The primary variable for the safety analysis will be the overall incidence of adverse experiences. | — |
Countries
Denmark, Finland, France, Germany, Italy, Lithuania
Outcome results
None listed