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Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen

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ClinicalTrials.gov Identifier: NCT00791973
Recruitment Status : Completed
First Posted : November 17, 2008
Results First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Robert Naclerio, University of Chicago

Tracking Information
First Submitted Date  ICMJE November 13, 2008
First Posted Date  ICMJE November 17, 2008
Results First Submitted Date  ICMJE June 6, 2014
Results First Posted Date  ICMJE July 8, 2014
Last Update Posted Date July 8, 2014
Study Start Date  ICMJE November 2008
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2014)
Change in Tryptase Level From Baseline to Post-antigen Challenge [ Time Frame: After one week of treatment wtih veramyst or placebo ]
Tryptase levels (mcg/L) were measured from nasal lavages
Original Primary Outcome Measures  ICMJE
 (submitted: November 14, 2008)
The primary endpoint will be the difference in change in the level of tryptase after antigen challenge between fluticasone furoate and placebo [ Time Frame: following antigen challenge ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2014)
Total Eye Symptom Scores After Antigen Challenge [ Time Frame: After one week of treatment wtih veramyst or placebo ]
Watery and itchy eye symptoms will be scored based on the following scale: 0=no symptoms, 1= mild, 2= moderate, 3= severe
Original Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2008)
The difference in change in symptom scores after antigen challenge between fluticasone furoate and placebo [ Time Frame: following antigen challenge ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen
Official Title  ICMJE Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen
Brief Summary The purpose of this study is to help us to a better understanding of how nose and eye symptoms are related in patients with allergies.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Allergic Rhinitis
Intervention  ICMJE
  • Drug: fluticasone furoate
    2 puffs in each nostril once daily for 1 week
    Other Name: Veramyst
  • Drug: Placebo
    2 puffs in each nostril once daily for 1 week
Study Arms  ICMJE
  • Active Comparator: Veramyst, then Placebo
    fluticasone furoate (Veramyst) nasal spray once daily for a week, then one week washout period followed by placebo nasal spray once daily for a week
    Interventions:
    • Drug: fluticasone furoate
    • Drug: Placebo
  • Active Comparator: Placebo, then Veramyst
    placebo nasal spray once daily for a week, then one week washout period followed by fluticasone furoate (veramyst) nasal spray once daily for a week
    Interventions:
    • Drug: fluticasone furoate
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 14, 2008)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Males and females between 18 and 45 years of age.
  2. History of grass and/or ragweed allergic rhinitis.
  3. Positive skin test to 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00791973
Other Study ID Numbers  ICMJE 16367B (OC 3)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robert Naclerio, University of Chicago
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
Principal Investigator: Robert Naclerio, MD University of Chicago
PRS Account University of Chicago
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP