Status:
TERMINATED
The Addition of Montelukast to Fluticasone in the Treatment of Perennial Allergic Rhinitis
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Rhinitis, Allergic, Perennial
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
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 me...
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 com...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00119015
Start Date
July 1 2005
End Date
January 1 2009
Last Update
February 28 2014
Active Locations (1)
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1
The University of Chicago
Chicago, Illinois, United States, 60637