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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

Page last updated: August 23, 2015

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