Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen
This study has been completed.
Sponsor:
University of Chicago
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Robert Naclerio, University of Chicago
ClinicalTrials.gov Identifier:
NCT00791973
First received: November 13, 2008
Last updated: June 14, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Allergic Rhinitis |
Drug: fluticasone furoate Drug: fluticasone furoate placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen |
Resource links provided by NLM:
Further study details as provided by University of Chicago:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 15 |
| Study Start Date: | November 2008 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
fluticasone furoate nasal spray once daily for a week
|
Drug: fluticasone furoate
2 puffs in each nostril once daily for 1 week
Other Name: Veramyst
|
| Placebo Comparator: 2 |
Drug: fluticasone furoate placebo
2 puffs in each nostril once daily for 1 week
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Males and females between 18 and 45 years of age.
- History of grass and/or ragweed allergic rhinitis.
- Positive skin test to 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00791973
Locations
| United States, Illinois | |
| University of Chicago Medical Center | |
| Chicago, Illinois, United States, 60637 | |
Sponsors and Collaborators
University of Chicago
GlaxoSmithKline
Investigators
| Principal Investigator: | Robert Naclerio, MD | University of Chicago |
More Information
No publications provided
| Responsible Party: | Robert Naclerio, MD, University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00791973 History of Changes |
| Other Study ID Numbers: | 16367B (OC 3) |
| Study First Received: | November 13, 2008 |
| Last Updated: | June 14, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Rhinitis Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Fluticasone Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 23, 2013