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

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: montelukast sodium

• Registration Number: NCT00229970
• Lead Sponsor: Organon and Co

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-28
• Study First Submitted QC: 2005-09-28
• Study First Posted: 2005-09-30
• Primary Completion: 2006-10
• Study Completion: 2007-06
• Results First Submitted: 2009-05-22
• Results First Submitted QC: 2009-05-22
• Results First Posted: 2009-07-17
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-31
• Last Update Posted: 2022-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	montelukast sodium	MK0476 14 mg injection
2	montelukast sodium	MK0476 7 mg injection

Primary Outcome Measures

Name	Time	Method
The Time-weighted Average of Change in Forced Expiratory Volume in One Second (FEV1)	baseline over the first 60 minutes	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