NCT00739297

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

A Phase Ib Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Bronchodilatory Effect of MK0476 in Patients With Chronic Asthma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 15 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Asthma

Interventions

Type	Name	Description
DRUG	Comparator: montelukast	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.
DRUG	Comparator: placebo	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.

Timeline

• Start date: 2008-07-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2008-08-21
• Last updated: 2024-05-09
• Results posted: 2010-04-09