Vitamin D Plus Fluticasone Propionate

Study Overview
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Brief Summary
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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.

Official Title
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The Addition of Vitamin D to Fluticasone Propionate in the Management of Seasonal Allergic Rhinitis

Conditions
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Seasonal Allergic Rhinitis

Intervention / Treatment
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* Drug: Vitamin D3
* Drug: Placebo
* Drug: Fluticasone Propionate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Males and females between 18 and 45 years of age. History of tree, grass and/or ragweed allergic rhinitis. Positive skin test to tree, grass and/or ragweed antigen. Positive response to screening nasal challenge. Exclusion Criteria Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease. Pregnant or lactating women. Upper respiratory infection within 14 days of study start.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fluticasone Propionate plus Vitamin D3<br>Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season | Drug: Vitamin D3<br>* 4000 IU once daily<br>Drug: Fluticasone Propionate<br>* 200 mcg daily, intranasal<br>* Other names: Flonase;|
| Placebo Comparator: Fluticasone Propionate plus Placebo<br>Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season | Drug: Placebo<br>* Placebo taken once daily<br>Drug: Fluticasone Propionate<br>* 200 mcg daily, intranasal<br>* Other names: Flonase;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 2 weeks |