Vitamin D Plus Fluticasone Propionate

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

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 Overview

• Status: Completed
• Conditions: Seasonal Allergic Rhinitis
• Intervention / Treatment: Drug: Vitamin D3; Drug: Fluticasone Propionate; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Chicago

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: April 13, 2010
• First Submitted That Met QC Criteria: April 14, 2010
• First Posted (Estimate): April 15, 2010

Study Record Updates

• Last Update Posted (Estimate): October 9, 2014
• Last Update Submitted That Met QC Criteria: October 6, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Dermatologic Agents; Micronutrients; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Anti-Allergic Agents; Vitamin D; Cholecalciferol; Fluticasone; Xhance
• Other Study ID Numbers: 10-184-B