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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Robert Naclerio, University of Chicago
ClinicalTrials.gov Identifier:
NCT00791973
First received: November 13, 2008
Last updated: June 6, 2014
Last verified: June 2014

November 13, 2008
June 6, 2014
November 2008
April 2009   (final data collection date for primary outcome measure)
Change in Tryptase Level From Baseline to Post-antigen Challenge [ Time Frame: After one week of treatment wtih veramyst or placebo ] [ Designated as safety issue: No ]
Tryptase levels (mcg/L) were measured from nasal lavages
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00791973 on ClinicalTrials.gov Archive Site
Total Eye Symptom Scores After Antigen Challenge [ Time Frame: After one week of treatment wtih veramyst or placebo ] [ Designated as safety issue: No ]
Watery and itchy eye symptoms will be scored based on the following scale: 0=no symptoms, 1= mild, 2= moderate, 3= severe
The difference in change in symptom scores after antigen challenge between fluticasone furoate and placebo [ Time Frame: following antigen challenge ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen
Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Allergic Rhinitis
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
May 2010
April 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00791973
16367B (OC 3)
No
Robert Naclerio, University of Chicago
University of Chicago
GlaxoSmithKline
Principal Investigator: Robert Naclerio, MD University of Chicago
University of Chicago
June 2014

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