CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 68 enrolled
Drug / intervention
Comparator: montelukast +1 moredrug
Likely dose
Comparator: montelukast 25 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00739297
NCT00739297Phase 1Completed
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A Phase Ib Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Bronchodilatory Effect of MK0476 in Patients With Chronic Asthma

Organon and Co·interventional·Posted Aug 21, 2008·Updated May 9, 2024

In Brief

A Phase 1 clinical trial evaluating Comparator: montelukast and Comparator: placebo for Chronic Asthma. Completed, enrolled 68 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Asthma
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 21, 2008
Enrollment StartJul 1, 2008
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 17.9 years ago

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

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.