The Safety and Effectiveness of MK0476 (Montelukast) in Patients With Chronic Asthma (0476-388)

Organon and Co68 enrolled

Overview

This study will test the safety and effectiveness of a range of doses of MK0476 (montelukast) compared to placebo on improved lung function in patients with chronic asthma.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Asthma

Interventions

Comparator: montelukastDRUG

5 Period, Cross-over, Dose-Ranging study. Period I: no treatment. Periods II-V: Single-dose administration of inhaled montelukast (using doses as low as 25 mcg, to as high as 1000 mcg), or montelukast placebo. Two puffs of albuterol or albuterol placebo will be given four hours after montelukast/montelukast placebo.

Comparator: placeboDRUG

Eligibility

Sex: ALLMin age: 15 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * A person is 15 to 65 years of age. A person has had chronic asthma for at least one year Exclusion Criteria: * A person is a smoker or has smoked more that a pack a day for more than 10 years before stopping * A person has other lung disorders such as COPD (chronic obstructive pulmonary disorder)

Outcomes

Primary Outcomes

Change From Baseline in FEV1 Over 4 Hours

FEV1 measurements taken at 0 (=baseline), 10, 20, 30, 45, 60, 120, 180 and 240 minutes contributed to the average change from baseline over 4 hours. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement.

Time frame: 0 (=baseline) to 4 hours after treatment with montelukast

Secondary Outcomes

Change From Baseline in FEV1 Over 90 Minutes After Albuterol/Placebo Administration

FEV1 measurements taken at 0 (=baseline), 15, 30, 60, and 90 minutes after albuterol/placebo administration contributed to the average change from baseline over 90 minutes. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement.

Time frame: 4 hours (equals time point at which albuterol or albuterol placebo is administered) to 5.5 hours after treatment with montelukast

Data from ClinicalTrials.gov

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