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

History of Changes

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: 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:

Drug Information available for: Fluticasone propionate Fluticasone Fluticasone furoate

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


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: 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	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: 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	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

Eligibility


Ages Eligible for Study:	18 Years to 45 Years (Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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
Results First Received:	June 6, 2014
Last Updated:	June 6, 2014
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Rhinitis Rhinitis, Allergic Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases	Fluticasone Anti-Inflammatory Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Dermatologic Agents Anti-Allergic Agents

ClinicalTrials.gov processed this record on September 23, 2016

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