Rhinitis, Allergic, Perennial Clinical Trial
Official title:
The Addition of Montelukast to Fluticasone in the Treatment of Perennial Allergic Rhinitis
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).
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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