CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 31 enrolled
Drug / intervention
montelukast +1 moredrug
Likely dose
montelukast 10 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.

Search/NCT00590772
NCT00590772Phase 4Completed
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Phase 4- The Role of Montelukast on Perennial Rhinitis and Associated Sleep Disturbance and Daytime Somnolence

Penn State University·interventional·Posted Jan 11, 2008·Updated Oct 21, 2014

In Brief

A Phase 4 clinical trial evaluating montelukast and placebo for Perennial Allergic Rhinitis. Completed, enrolled 31 participants.

Detailed Summary

The hypothesis is that a leukotriene receptor antagonist (LRA), montelukast, will decrease nasal congestion leading to increased patency of the nose and a decrease in nighttime sleep fragmentation in individuals with year round allergic rhinitis or perennial allergic rhinitis (PAR). This decrease in sleep fragmentation will reduce daytime somnolence and fatigue.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPerennial Allergic Rhinitis
Countries--
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 4CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 11, 2008
Enrollment StartMay 1, 2003
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 18.5 years ago

Interventions

montelukastdrug

10 mg po each day (compared to placebo for 2 weeks)

placebodrug

placebo for 2 weeks