A Multicenter, Randomized, Double-Blind Study Comparing the Clinical Effects of Intravenous Montelukast With Placebo in Patients With Acute Asthma. - Acute Asthma IV Study

• Conditions: Acute Asthma

• Registration Number: EUCTR2004-000614-39-DK
• Lead Sponsor: Merck Sharp & Dohme

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

?Patient is a male or female at least 18 years of age.
?Patient is admitted to the study site because of an acute exacerbation of asthma and has at least a 1 year (can be verbal information from the patient) history of asthma.
?During Period I, patient has a forced expiratory volume in 1 second (FEV1) of less than or equal to 50% of the predicted value on all measurements.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

?Based upon history or physical examination at the study site, the patient has any known or suspected, acute or chronic cause for their pulmonary symptoms other than asthma (e.g., congestive heart failure, etc.).
?As assessed in the study site, the patient’s asthma has life-threatening features, including, but not limited to, immediate respiratory failure, the need for intubation, evidence of a pneumothorax, or pneumomediastinum.
?The time between when the patient begins receiving treatment for acute asthma at the study site and study drug administration exceeds 60 minutes.
?Patient has received parenteral corticosteroids (any dose) or oral corticosteroids (in excess of their usual dose) within 12 hours of study site admission or during the preallocation period (Period I). (All allocated patients will receive systemic [oral] corticosteroids at the time of randomization.)
?Patient has begun an oral leukotriene receptor antagonist or a leukotriene synthesis inhibitor (marketed or investigational) within 2 weeks of study site admission or the patient is on chronic stable doses of anti-leukotriene agents, but the last dose was taken in the 12 hours prior to study site admission or during the preallocation period (Period I).
?Patient has received any anti-asthma therapies other than oxygen, beta-agonists, anticholinergics, or corticosteroids during Period I.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified