A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study Evaluating the Effects of 2 Different Regimens of Montelukast (Daily Dosing and Intermittent, Episode-Driven Dosing) Compared With Placebo in the Treatment of Episodic Asthma in Children Aged 6 Months to 5 Years - Intermittent and Daily Treatment for Episodic Asthma (IDEA)

• Conditions: episodic or intermittent asthma (not chronic asthma); MedDRA version: 8.1Level: LLTClassification code 10003553Term: Asthma

• Registration Number: EUCTR2006-002791-18-LT
• Lead Sponsor: Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1700

Inclusion Criteria

1. Patient is a male or female between the ages of 6 months and 5 years (71 months) inclusive.
2. For patients aged <2 years: patient has had at least 2 but no more than 4 episodes of asthma symptoms (e.g., cough, wheeze, shortness of breath) for approximately 3 days, each involving, at minimum, ß-agonist treatment, AND episodes are separated in time by periods without asthma symptoms (may be obtained as verbal medical history from parent/guardian).
For patients aged =2 years: 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, at minimum, 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. For patients >1 year: In the 12 months prior to Visit 1, patient had at least 1 corticosteroid treatment (oral, rectal, inhaled, or parenteral) OR was hospitalized for asthma at least 1 time (may be obtained as verbal medical history from parent/guardian).
For patients <1 year: Patient had at least 1 corticosteroid treatment (oral, rectal, inhaled, or parenteral) 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) 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

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 patients <2 years: for =2 months, cumulatively.
• For patients =2 year: for =4 months, cumulatively, in the 12 months prior to Visit 1.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified