At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 46 enrolled
Drug / intervention
Montelukast +1 moredrug
Likely dose
Montelukast 0.1 mgfrom 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.
A Sequential, 3-Part, Double-Blind, Randomized, Placebo-Controlled, Single-Rising-Dose and Rising-Multiple-Dose Study in Healthy Subjects and Mild or Moderate Asthmatic Patients to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled MK-0476
In Brief
A Phase 1 clinical trial evaluating Montelukast and Placebo for Asthma. Completed, enrolled 46 participants.
Detailed Summary
A study to evaluate the safety, tolerability and pharmacokinetics of inhaled Montelukast (MK-0476) in participants with mild or moderate asthma.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2007
First PostedMar 2008
Primary CompletionSep 2008
Study CompletionOct 2008
TodayJul 2026
First PostedMar 14, 2008
Enrollment StartAug 1, 2007
Primary CompletionSep 1, 2008
Study CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 18.3 years ago
Interventions
Montelukastdrug
Montelukast dry powder inhaler, 0.1 mg, 0.3 mg, 1 mg, 3 mg or 10 mg
Placebodrug
Placebo dry powder inhaler