A Multicenter, Randomized, Double-Blind Study Comparing the Clinical Effects of Intravenous Montelukast With Placebo in Patients With Acute Asthma
Overview
- Phase
- Phase 3
- Intervention
- montelukast sodium
- Conditions
- Asthma
- Sponsor
- Organon and Co
- Enrollment
- 650
- Primary Endpoint
- Improvement in forced expiratory volume in 1 second [FEV1] within the first 60 minutes after administration
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to evaluate improved results of treatment for patients entering an emergency department with asthma attacks when given an investigational IV administration of an approved drug (MK-0476, montelukast sodium) in addition to approved standard treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Individuals with acute asthma
Exclusion Criteria
- •Women of child bearing age
- •History of Chronic Obstructive Pulmonary Disease (COPD)
Arms & Interventions
Montelukast 7 mg
Participants receive montelukast 7 mg intravenously (IV) until until a decision is made for one of the following: (1) discontinuation from the study, (2) discharge from the study site, or (3) admission to the hospital. All randomized participants will receive systemic corticosteroids (60 mg prednisone OR 50 mg prednisolone) orally immediately after the completion of the study drug administration. In addition, all participants will continue to receive standardized treatment in addition to study drug. Standardized treatment may consist of: (1) β-agonist administration beginning 20 minutes after study drug infusion, and every 20 minutes thereafter, as needed; (2) oxygen therapy; and (3) inhaled ipratropium every 60 minutes as needed.
Intervention: montelukast sodium
Placebo
Participants receive placebo IV until until a decision is made for one of the following: (1) discontinuation from the study, (2) discharge from the study site, or (3) admission to the hospital. All randomized participants will receive systemic corticosteroids (60 mg prednisone OR 50 mg prednisolone) orally immediately after the completion of the study drug administration. In addition, all participants will continue to receive standardized treatment in addition to study drug. Standardized treatment may consist of: (1) β-agonist administration beginning 20 minutes after study drug infusion, and every 20 minutes thereafter, as needed; (2) oxygen therapy; and (3) inhaled ipratropium every 60 minutes as needed.
Intervention: placebo
Outcomes
Primary Outcomes
Improvement in forced expiratory volume in 1 second [FEV1] within the first 60 minutes after administration
Time Frame: within the first 60 minutes after administration
Secondary Outcomes
- Incidence of treatment failures, amount of additional therapy[short-acting B-agonist] required, rate of FEV1 improvement, safety and tolerability(Duration of trial)