Phase 3 N=1,771 Randomized Double-blind Treatment

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

Asthma

Bottom Line

View on ClinicalTrials.gov: NCT00337675 ↗

Enrolled (actual)

1,771

Serious AEs

5.8%

Results posted

Mar 2010

Primary outcome: Primary: Number of Asthma Episodes Culminating in Asthma Attack Over the 1-year Treatment Period — 0.99; 1.06; 1.05 Asthma attacks within episodes per year — p=0.510

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: montelukast sodium (Drug); Comparator: Placebo (unspecified) (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Organon and Co
Primary completion: Aug 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Asthma Episodes Culminating in Asthma Attack Over the 1-year Treatment Period	0.99; 1.06; 1.05	0.510
SECONDARY Daily Average of Wheeze and Difficulty Breathing in the 3 Days Prior to Start of an Asthma Attack Within an Asthma Episode	1.69; 1.70; 1.88	0.176
SECONDARY 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	1.08; 1.09; 1.20	0.045 sig

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).

Eligibility Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00337675). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.