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Sponsors and Collaborators: |
University of Chicago Merck |
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Information provided by: | University of Chicago |
ClinicalTrials.gov Identifier: | NCT00119015 |
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).
Condition | Intervention | Phase |
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Rhinitis, Allergic, Perennial |
Drug: placebo Drug: montelukast |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | The Addition of Montelukast to Fluticasone in the Treatment of Perennial Allergic Rhinitis |
Estimated Enrollment: | 80 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: Placebo Comparator |
Drug: placebo
1 tablet daily in the morning
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1: Active Comparator
montelukast 10 mg po daily
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Drug: montelukast
10 mg po daily
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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 no more effective at relieving symptoms than a placebo.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Marcy deTineo, BSN, CCRC | 773-702-5889 | mdetineo@surgery.bsd.uchicago.edu |
United States, Illinois | |
The University of Chicago | Recruiting |
Chicago, Illinois, United States, 60637 | |
Contact: Marcy deTineo, BSN, CCRC 773-702-5889 mdetineo@surgery.bsd.uchicago.edu | |
Principal Investigator: Robert M Naclerio, MD |
Principal Investigator: | Robert M Naclerio, MD | University of Chicago |
Responsible Party: | University ofChicago ( Robert Naclerio, MD ) |
Study ID Numbers: | 13875B, SING-US-60-04 |
Study First Received: | July 1, 2005 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00119015 |
Health Authority: | United States: Institutional Review Board |
perennial allergic rhinitis |
Montelukast Hypersensitivity Otorhinolaryngologic Diseases Respiratory Tract Infections Respiratory Tract Diseases Rhinitis, Allergic, Perennial |
Hypersensitivity, Immediate Fluticasone Rhinitis Leukotriene Antagonists Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Immune System Diseases Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Anti-Allergic Agents |
Nose Diseases Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents Dermatologic Agents |