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

The University of Chicago

Status and phase: Terminated; Phase 4

Conditions: Rhinitis, Allergic, Perennial

Treatments: Drug: Montelukast; Drug: Placebo; Drug: Fluticasone propionate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00119015

13875B

SING-US-60-04

Details and patient eligibility

About

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).

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• A clinical history of perennial allergic rhinitis and a positive skin prick test to dust mite, cockroach, mold, or cat or dog antigens.
• Willingness of the subject to participate in and complete the study, and the ability to understand the purpose of the trial.

Exclusion criteria

• Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
• Women of childbearing potential who are pregnant, trying to become pregnant or nursing a child.
• Subjects treated with systemic steroids during the previous 30 days.
• Subjects treated with topical (inhaled, intranasal or intraocular) steroids, Nasalcrom or Opticrom during the previous 15 days.
• Subjects treated with oral antihistamines/decongestants during the previous seven days.
• Subjects treated with topical (intranasal or intraocular) antihistamines/decongestants during the previous 3 days.
• Subjects treated with immunotherapy who are escalating their dose.
• Subjects on chronic anti-asthma medications.
• Subjects with polyps in the nose or a significantly displaced septum.
• Subjects who have incurred an upper respiratory tract infection within 14 days of the start of the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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102 participants in 2 patient groups, including a placebo group

Fluticasone propionate + Placebo

Placebo Comparator group

Description:

Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily) Placebo - 10 mg po daily for 2 weeks

Treatment:

Drug: Fluticasone propionate

Drug: Placebo

Fluticasone propionate + Montelukast

Active Comparator group

Description:

Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily) Montelukast - 10 mg po daily for 2 weeks

Treatment:

Drug: Fluticasone propionate

Drug: Montelukast