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

Tracking Information

First Received Date ^ICMJE

November 13, 2008

Last Updated Date

May 6, 2009

Start Date ^ICMJE

November 2008

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00791973 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Control:  Placebo Control
Endpoint Classification:  Efficacy Study
Intervention Model:  Crossover Assignment
Masking:  Double Blind (Subject, 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: fluticasone furoate placebo
2 puffs in each nostril once daily for 1 week

Study Arms / Comparison Groups

1: Active Comparator
fluticasone furoate nasal spray once daily for a week

Intervention: Drug: fluticasone furoate
2: Placebo Comparator
Intervention: Drug: fluticasone furoate placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

September 2009

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00791973

Responsible Party

Robert Naclerio, MD, University of Chicago

Study ID Numbers ^ICMJE

16367B (OC 3)

Study Sponsor ^ICMJE

University of Chicago

Collaborators ^ICMJE

GlaxoSmithKline

Investigators ^ICMJE

Principal Investigator:

Robert Naclerio, MD

University of Chicago

Information Provided By

University of Chicago

Verification Date

May 2009

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