Vitamin D Plus Fluticasone Propionate
Information source: University of Chicago
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Seasonal Allergic Rhinitis
Intervention: Vitamin D3 (Drug); Placebo (Drug); Fluticasone Propionate (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Chicago Official(s) and/or principal investigator(s): Robert M Naclerio, MD, Principal Investigator, Affiliation: University of Chicago
Summary
The objectives of this study would be to see if the addition of vitamin D to fluticasone
propionate provides greater symptomatic relief in patients with seasonal allergic rhinitis
compared to fluticasone propionate treatment alone.
Clinical Details
Official title: The Addition of Vitamin D to Fluticasone Propionate in the Management of Seasonal Allergic Rhinitis
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period
Secondary outcome: Change From Baseline in Daytime Nasal Symptom Score (DNSS) Over 2 Week Randomized Treatment Period
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria
1. Males and females between 18 and 45 years of age.
2. History of tree, grass and/or ragweed allergic rhinitis.
3. Positive skin test to tree, grass and/or ragweed antigen.
4. Positive response to screening nasal challenge.
Exclusion Criteria
1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
2. Pregnant or lactating women.
3. Upper respiratory infection within 14 days of study start.
Locations and Contacts
The University of Chicago, Chicago, Illinois 60637, United States
Additional Information
Starting date: June 2010
Last updated: October 6, 2014
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