Phase 3 N=225 Randomized Double-blind Treatment

MK0476 Study in Adult Patients With Acute Asthma (0476-322)

Asthma

Bottom Line

View on ClinicalTrials.gov: NCT00229970 ↗

Enrolled (actual)

225

Serious AEs

—

Results posted

Jul 2009

Primary outcome: Primary: The Time-weighted Average of Change in Forced Expiratory Volume in One Second (FEV1) — 0.09; 0.17; 0.01 Liter — p=0.022

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: montelukast sodium (Drug); Comparator: Placebo (Drug)
Age: Pediatric, Adult, Older Adult · 15+ yrs
Sex: All
Sponsor: Organon and Co
Primary completion: Oct 2006

Outcome Measures

Outcome	Result	p-value
PRIMARY The Time-weighted Average of Change in Forced Expiratory Volume in One Second (FEV1)	0.09; 0.17; 0.01	0.022 sig

Summary

This study evaluates the efficacy and safety of MK0476 intravenous administration in adult patients with acute asthma.

Eligibility Criteria

Inclusion Criteria

Adult Patients With Acute Asthma Attacks

Exclusion Criteria

Patient Has Any Known Or Suspected, Acute Or Chronic Cause For Their Pulmonary Symptoms Other Than Asthma (E.G., Copd, Chronic Heart Failure, Etc.)
Patient Has A Smoking History (20 Cigarettes Per Day) Of More Than 15 Years
Patient Has A Disease Of The Cardiovascular, Hepatic, Renal, Hematologic Systems, Or Other Severe Disease

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00229970). 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.