Intermittent and Daily Dosing for Episodic (Periodic) Asthma (0476-302)(COMPLETED)

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: montelukast sodium

• Registration Number: NCT00337675
• Lead Sponsor: Organon and Co

Brief Summary

This is a year-long study evaluating the efficacy of both daily and intermittent treatment of asthma in children who experience symptoms episodically (i.e., seasonally, usually in the context of upper respiratory tract infection).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-06-14
• Study First Submitted QC: 2006-06-14
• Study First Posted: 2006-06-16
• Study Start: 2006-10
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Results First Submitted: 2010-02-19
• Results First Submitted QC: 2010-02-19
• Results First Posted: 2010-03-15
• Status Verified: 2022-01
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1771

Inclusion Criteria

• Patients aged 6 months to 5 years with episodic (periodic) asthma

Exclusion Criteria

• Patients who are not in otherwise good health
• Patients who have persistent asthma (continual asthma symptoms)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: drug + episodic supplemental placebo	montelukast sodium	Montelukast once a day (qd) + episode driven supplemental placebo qd for 12 days for a 52-wk treatment period
Arm 2: placebo comparator + episodic supplemental drug	montelukast sodium	Placebo qd + episode driven supplemental Montelukast qd for 12 days for a 52-wk treatment period

Primary Outcome Measures

Name	Time	Method
Number of Asthma Episodes Culminating in Asthma Attack Over the 1-year Treatment Period	1-year treatment period	The rate per year of asthma episodes culminating in an asthma attack for each of the 3 treatment groups. Asthma attacks were defined as respiratory symptoms requiring healthcare resource utilization (HRU), which comprised unscheduled visits to a physician or emergency department, treatment with corticosteroids (oral, rectal, or inhaled), or hospitalization. Each day during an episode, the patient's legal guardian recorded all the HRU that was required specifically for breathing problems.

Secondary Outcome Measures

Name	Time	Method
Daily Average of Wheeze and Difficulty Breathing in the 3 Days Prior to Start of an Asthma Attack Within an Asthma Episode	1 Year	Each day during an asthma episode, the patient's legal guardian was asked to rate each of the symptoms of wheeze and difficulty breathing on a 6-point scale (Scale 0 (best) to 5 (worst)). The average of the individual symptom scores on each of the 3 days prior to an asthma attack was reported. If a patient had multiple episodes during 1 year, the symptom scores were averaged across all the episodes.
Daily Average of the Mean Symptom Scores (Wheeze, Difficulty Breathing, Interference With Activity, and Daytime Cough) Assessed Over the 12-day Treatment Period of Asthma Episodes	1 Year	Each day during an asthma episode, the patient's legal guardian was asked to rate each of the symptoms of Wheeze, Difficulty Breathing, Interference with Activity, and Daytime Cough on a 6-point scale (Scale 0 (best) to 5 (worst)). The average of the individual symptom scores on each of the 12 days of intermittent treatment for an episode (before the first attack) was reported. If a patient had multiple episodes over 1 year, the symptom scores were averaged across all the episodes.