Study of MK0476 in Adult Patients With Acute Asthma
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: MK0476, montelukast sodium / Duration of Treatment: 1 Day (Drug); Comparator: Aminophylline / Duration of Treatment: 1 dose (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
The study estimates the efficacy and safety of MK0476 and aminophylline intravenous
administration in adult patients with acute asthma.
Clinical Details
Official title: MK0476 Phase III Open Label Exploratory Comparative Clinical Study -Acute Exacerbations of Asthma -
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Improvement in forced expiratory volume in one second (fev1) within the first 60 minutes after administration
Eligibility
Minimum age: 15 Years.
Maximum age: 75 Years.
Gender(s): Both.
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 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.
- Patient has a disease of the cardiovascular, hepatic, renal, hematologic systems, or
other severe disease.
Locations and Contacts
Additional Information
Starting date: February 2007
Last updated: August 20, 2007
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