NCT01103934|CompletedPhase 4Results
Vitamin D Plus Fluticasone Propionate
The Addition of Vitamin D to Fluticasone Propionate in the Management of Seasonal Allergic Rhinitis
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Sponsor study identifier
interventional
35
1 country
1
Study Start
June 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2011
Actual (reported)Study Completion
July 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2011
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 13, 2010
Actual (reported)April 15, 2010
Actual (reported)June 2010
Date type not reportedThis date has not been verified as actual or estimated.
July 2011
Actual (reported)July 2011
Actual (reported)October 9, 2014
Actual (reported)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
Change From Baseline in Daytime Nasal Symptom Score (DNSS) Over 2 Week Randomized Treatment Period
Baseline and 2 weeks
Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season
Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season
The University of Chicago
Chicago, Illinois, 60637, United States
Robert M Naclerio, MD
University of Chicago
35 participants (actual enrollment reported by the registry).
First Submitted
April 13, 2010
First Posted
April 15, 2010
Study Start
June 2010
Date type not reportedThis date has not been verified as actual or estimated.
200 mcg daily, intranasal
Contact the study team to confirm eligibility.
Primary Completion
July 2011
Actual (reported)Study Completion
July 2011
Actual (reported)Last Updated
October 9, 2014
Results First Posted
October 9, 2014
Record last verified: 2014-10
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Source: ClinicalTrials.gov.
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