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NCT00229970 Clinical Trial

MK0476 Study in Adult Patients With Acute Asthma (0476-322)

Asthma Clinical Trial

Official title:
MK0476 Phase II/III Placebo Controlled Double Blind Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00229970
Other study ID # 0476-322
Secondary ID MK0476-3222005_0
Status Completed
Phase Phase 3
First received
Last updated
Start date September 2005
Est. completion date June 2007

Study information
Verified date January 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates the efficacy and safety of MK0476 intravenous administration in adult patients with acute asthma.

Recruitment information / eligibility
Status Completed
Enrollment 225
Est. completion date June 2007
Est. primary completion date October 2006
Accepts healthy volunteers No
Gender All
Age group 15 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• montelukast sodium
7 mg or 14 mg single injection
• Comparator: Placebo
Placebo single injection

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

Outcome
Type Measure Description Time frame Safety issue
Primary The Time-weighted Average of Change in Forced Expiratory Volume in One Second (FEV1) The Time Weighed Average Changes in Forced Expiratory Volume in One Second (FEV1) from pre-allocation baseline over the first 60 minutes after study drug administration with time interval between any measurement and the measurement prior to it is used as the weighting factor baseline over the first 60 minutes
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