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Completed

NCT Number: NCT01103934

Vitamin D Plus Fluticasone Propionate

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.

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Key information

Conditions

Seasonal Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The University of Chicago

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin D3

Drug

4000 IU once daily

Placebo

Drug

Placebo taken once daily

Fluticasone propionate

Drug

200 mcg daily, intranasal

Other names: Flonase

Primary outcomes

  1. Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period

    Time frame: 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 outcomes

  1. Change From Baseline in Daytime Nasal Symptom Score (DNSS) Over 2 Week Randomized Treatment Period

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 15, 2010
Registry last updated
Oct 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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