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Vitamin D Plus Fluticasone Propionate

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01103934
First received: April 13, 2010
Last updated: October 6, 2014
Last verified: October 2014
  Purpose
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.

Condition Intervention Phase
Seasonal Allergic Rhinitis
Drug: Vitamin D3
Drug: Placebo
Drug: Fluticasone Propionate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Addition of Vitamin D to Fluticasone Propionate in the Management of Seasonal Allergic Rhinitis

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
    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:
  • Change From Baseline in Daytime Nasal Symptom Score (DNSS) Over 2 Week Randomized Treatment Period [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 35
Study Start Date: June 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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: Placebo
Placebo taken once daily
Drug: Fluticasone Propionate
200 mcg daily, intranasal
Other Name: Flonase

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01103934

Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Robert M Naclerio, MD University of Chicago
  More Information

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01103934     History of Changes
Other Study ID Numbers: 10-184-B 
Study First Received: April 13, 2010
Results First Received: October 6, 2014
Last Updated: October 6, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Fluticasone
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on September 23, 2016