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

NCT ID: NCT00119015

Last Updated: 2014-02-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2009-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Fluticasone propionate + Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Fluticasone propionate

Intervention Type: DRUG

Fluticasone propionate + Montelukast

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

Group Type: ACTIVE_COMPARATOR

Montelukast

Intervention Type: DRUG

Fluticasone propionate

Intervention Type: DRUG

Interventions

Placebo

Intervention Type: DRUG

Montelukast

Intervention Type: DRUG

Fluticasone propionate

Intervention Type: DRUG

Other Intervention Names

singulair; flonase

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert M Naclerio, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

The University of Chicago

Chicago, Illinois, United States

Countries

United States

References

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Other Identifiers

SING-US-60-04

Identifier Type: -

Identifier Source: secondary_id

13875B

Identifier Type: -

Identifier Source: org_study_id