The Addition of Montelukast to Fluticasone in the Treatment of Perennial Allergic Rhinitis
Overview[ - collapse ][ - ]
Purpose | 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 | Rhinitis, Allergic, Perennial |
Intervention | Drug: Placebo Drug: Montelukast Drug: Fluticasone propionate |
Phase | Phase 4 |
Sponsor | University of Chicago |
Responsible Party | University of Chicago |
ClinicalTrials.gov Identifier | NCT00119015 |
First Received | July 1, 2005 |
Last Updated | January 27, 2014 |
Last verified | January 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | July 1, 2005 |
---|---|
Last Updated Date | January 27, 2014 |
Start Date | July 2005 |
Estimated Primary Completion Date | January 2009 |
Current Primary Outcome Measures | Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period [Time Frame: Baseline and 2 weeks] [Designated as safety issue: No]Patients recorded the severity of sneezing, runny nose, stuffy nose, and other symptoms (itchy nose/eyes and post-nasal drip) twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The TNSS was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 24. The baseline TNSS used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period. The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group. A negative value indicates an improvement in symptoms. |
Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
Brief Title | The Addition of Montelukast to Fluticasone in the Treatment of Perennial Allergic Rhinitis |
---|---|
Official Title | The Addition of Montelukast to Fluticasone in the Treatment of Perennial Allergic Rhinitis |
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. |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
Condition | Rhinitis, Allergic, Perennial |
Intervention | Drug: Placebo Drug: Montelukast Other Names: singulairDrug: Fluticasone propionate Other Names: flonase |
Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
Recruitment Status | Terminated |
---|---|
Estimated Enrollment | 102 |
Estimated Completion Date | January 2009 |
Estimated Primary Completion Date | June 2008 |
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. |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00119015 |
---|---|
Other Study ID Numbers | 13875B |
Has Data Monitoring Committee | No |
Information Provided By | University of Chicago |
Study Sponsor | University of Chicago |
Collaborators | Merck Sharp & Dohme Corp. |
Investigators | Principal Investigator: Robert M Naclerio, MD University of Chicago |
Verification Date | January 2014 |
Locations[ + expand ][ + ]
The University of Chicago | Chicago, Illinois, United States, 60637 |
---|