Phase 3
Completed N=91
Study of MK-0476 in Adult Patients With Acute Asthma (0476-334)
Source: ClinicalTrials.gov NCT00442338 ↗Enrolled (actual)
91
Serious AEs
4.4%
Results posted
Jul 2009
Primary outcomePrimary: 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
Summary
The study estimates the efficacy and safety of MK0476 and aminophylline intravenous administration in adult participants with acute asthma.
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 |
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.
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. Informational only — not medical advice.