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

• Status: Terminated
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Chicago
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Fluticasone; Montelukast; Xhance

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.