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

Phase 3CompletedNCT00229970

Organon and Co225 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

225

Conditions

Asthma

Interventions

montelukast sodiumDRUG

7 mg or 14 mg single injection

Comparator: PlaceboDRUG

Placebo single injection

Eligibility

Sex: ALLMin age: 15 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: baseline over the first 60 minutes

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.