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The Role of Montelukast in Rhinitis and Sleep

NCT00590772 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2014-10-21

Study results available
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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.

Conditions

  • Perennial Allergic Rhinitis

Interventions

DRUG

montelukast

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

DRUG

placebo

placebo for 2 weeks

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
16 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-05-31
Primary Completion
2009-01-31
Completion
2009-01-31

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00590772 on ClinicalTrials.gov