Phase 3 N=91 Randomized Treatment

Study of MK-0476 in Adult Patients With Acute Asthma (0476-334)

Asthma

Bottom Line

View on ClinicalTrials.gov: NCT00442338 ↗

Enrolled (actual)

Serious AEs

4.4%

Results posted

Jul 2009

Primary outcome: Primary: Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Within the First 60 Minutes After Administration — 0.07; 0.05; 0.06 Liter — p=0.871

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: montelukast sodium (Drug); aminophylline hydrate (Drug)
Age: Pediatric, Adult, Older Adult · 15+ yrs
Sex: All
Sponsor: Organon and Co
Primary completion: Aug 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Within the First 60 Minutes After Administration	0.07; 0.05; 0.06	0.871

Summary

The study estimates the efficacy and safety of MK0476 and aminophylline intravenous administration in adult participants with acute asthma.

Eligibility Criteria

Inclusion Criteria

Adult participants with acute asthma attacks

Exclusion Criteria

Participant has any known or suspected, acute or chronic cause for their pulmonary symptoms other than asthma (e.g., COPD, chronic heart failure, etc.).
Participant has a smoking habit (15 cigarettes per day) within a month prior to screening period, and/or has a smoking history (20 cigarettes per day) of more than 15 years.
Participant 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 (NCT00442338). 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.