Vitamin D Plus Fluticasone Propionate

Phase 4

Completed

• Conditions: Seasonal Allergic Rhinitis
• Interventions: Drug: Placebo; Drug: Vitamin D3; Drug: Fluticasone Propionate

• Registration Number: NCT01103934
• Lead Sponsor: University of Chicago

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-13
• Study First Submitted QC: 2010-04-14
• Study First Posted: 2010-04-15
• Study Start: 2010-06
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2014-10
• Results First Submitted: 2014-10-06
• Results First Submitted QC: 2014-10-06
• Last Update Submitted: 2014-10-06
• Results First Posted: 2014-10-09
• Last Update Posted: 2014-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluticasone Propionate plus Vitamin D3	Fluticasone Propionate	Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season
Fluticasone Propionate plus Placebo	Placebo	Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season
Fluticasone Propionate plus Placebo	Fluticasone Propionate	Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season
Fluticasone Propionate plus Vitamin D3	Vitamin D3	Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period	Baseline and 2 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Daytime Nasal Symptom Score (DNSS) Over 2 Week Randomized Treatment Period	Baseline and 2 weeks	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.

Trial Locations

Locations (1)

The University of Chicago; 🇺🇸 Chicago, Illinois, United States