MK0476 Study 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: Acute Asthma
Intervention: MK0476, montelukast sodium / Duration of Treatment: 1 Day (Drug); Placebo / Duration of Treatment: 1 Day (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
A study to evaluate the efficacy and safety of MK0476 intravenous administration in adult
patients with acute asthma.
Clinical Details
Official title: MK0476 Phase II/ III Placebo Controlled Double Blind Study
Study design: Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: To evaluate the improvement of Forced Expiratory Volume in one second (FEV1) from pre-allocation baseline in acute asthma between intravenous single administration of MK0476 and placebo.
Secondary outcome: No key secondary outcomes.
Eligibility
Minimum age: 15 Years.
Maximum age: 65 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 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: September 2005
Last updated: November 21, 2006
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