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

• 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: University of Chicago
• Collaborator: GlaxoSmithKline
• Information provided by (Responsible Party): Robert Naclerio, University of Chicago

Tracking Information

• First Submitted Date: November 13, 2008
• First Posted Date: November 17, 2008
• Results First Submitted Date: June 6, 2014
• Results First Posted Date: July 8, 2014
• Last Update Posted Date: July 8, 2014
• Study Start Date: November 2008
• Actual Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]

Current Secondary Outcome Measures (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 (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: Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Allergic Rhinitis

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 14, 2008): 15
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: May 2010
• Actual Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00791973
• Other Study ID Numbers: 16367B (OC 3)
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Robert Naclerio, University of Chicago
• Study Sponsor: University of Chicago
• Collaborators: GlaxoSmithKline

Investigators

• Principal Investigator: Robert Naclerio, MD; University of Chicago

• PRS Account: University of Chicago
• Verification Date: June 2014