Study of MK-0476 in Adult Patients With Acute Asthma (0476-334)
- Registration Number
- NCT00442338
- Lead Sponsor
- Organon and Co
- Brief Summary
The study estimates the efficacy and safety of MK0476 and aminophylline intravenous administration in adult participants with acute asthma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 91
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aminophylline 250 mg aminophylline hydrate Aminophylline 250 mg IV drip administration Montelukast 7 mg montelukast sodium Montelukast 7 mg IV administration Montelukast 14 mg montelukast sodium Montelukast 14 mg IV administration
- Primary Outcome Measures
Name Time Method Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Within the First 60 Minutes After Administration Baseline and 60 minutes after study drug administration The time weighted average change from Baseline in Forced Expiratory Volume in One Second (FEV1) over the first 60 minutes after study drug administration (average change FEV1 (0-60 min)). Baseline (pre-allocation) was the last measurement obtained during the screening period.
- Secondary Outcome Measures
Name Time Method