Vitamin D Plus Fluticasone Propionate

University of Chicago35 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Seasonal Allergic Rhinitis

Interventions

Vitamin D3DRUG

4000 IU once daily

PlaceboDRUG

Placebo taken once daily

Fluticasone PropionateDRUG

200 mcg daily, intranasal

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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 (1)

The University of Chicago

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period

Patients recorded the severity of sneezing, runny nose, stuffy nose, and other symptoms (e.g. itchy nose/throat) 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 change from baseline for each 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.

Time frame: Baseline and 2 weeks

Secondary Outcomes

Change From Baseline in Daytime Nasal Symptom Score (DNSS) Over 2 Week Randomized Treatment Period

Patients recorded the severity of sneezing, runny nose, stuffy nose, and other symptoms (e.g. itchy nose/throat) twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The DNSS was calculated as the sum of all scores for morning with a range of 0 to 12. The change from baseline for each 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 daytime symptoms.

Time frame: Baseline and 2 weeks

Data from ClinicalTrials.gov

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