NCT00119015

The Addition of Montelukast to Fluticasone in the Treatment of Perennial Allergic Rhinitis

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Some people with nasal allergy symptoms continue to have symptoms even after treatment with a nasal steroid spray. The purpose of this study is to see if these patients are helped by adding another medication (montelukast) to their treatment compared to placebo (a substance that looks like the active medication but does not contain the drug).

Detailed description

Clinicians frequently prescribe an oral H1 antihistamine for allergic rhinitis patients with residual symptoms after taking an intranasal steroid. Surprisingly, the only studies investigating this combination of drugs have failed to show added efficacy of the H1 receptor over the intranasal steroids alone. Adding montelukast, a leukotriene receptor antagonist, to an intranasal steroid has not been studied in a placebo controlled fashion. Wilson and colleagues, in an open study of patients with chronic rhinosinusitis, showed a benefit of adding montelukast. The investigators would like to recruit perennially allergic subjects and place them on fluticasone for 2 weeks. Those subjects with residual symptoms would then be randomized to receive either placebo or montelukast in addition to continuing the fluticasone for an additional 2 weeks. A positive study would support clinical practice and would serve as a preemptive strike against managed care plans that would not allow prescriptions for both drugs. Hypothesis: The addition of montelukast to treatment of a perennially allergic subject with an intranasal steroid is more effective at relieving symptoms than a placebo.

Conditions

• Rhinitis, Allergic, Perennial

Interventions

Type	Name	Description
DRUG	Placebo
DRUG	Montelukast
DRUG	Fluticasone propionate

Timeline

• Start date: 2005-07-01
• Primary completion: 2008-06-01
• Completion: 2009-01-01
• First posted: 2005-07-12
• Last updated: 2014-02-28
• Results posted: 2013-05-22

Locations

1 site across 1 country: United States