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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00609674 |
The purpose of this study is to compare the effects (effectiveness and safety) of an intranasal corticosteroid (fluticasone furoate nasal spray [FFNS]), with a placebo nasal spray for the treatment of perennial (year-round) allergic rhinitis.
Condition | Intervention | Phase |
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Perennial Allergic Rhinitis |
Drug: Fluticasone furoate nasal spray |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily Intranasal Administration of Fluticasone Furoate Nasal Spray 110mcg in Adult and Adolescent Subjects 12 Years of Age and Older With Perennial Allergic Rhinitis (PAR) |
Estimated Enrollment: | 288 |
Study Start Date: | January 2008 |
Study Completion Date: | June 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects eligible for enrollment in the study must meet all of the following criteria:
Age
To be eligible for entry into the study, females of childbearing potential must commit to the consistent and correct use of an acceptable method of birth control, as defined by the following:
A positive skin test is defined as a wheal ≥3mm larger than the diluent control for prick testing.
In vitro tests for specific IgE (such as RAST, PRIST) will not be allowed for the diagnosis of PAR.
NOTE: Subjects who meet the above criteria for PAR and who also have a history of allergy to a seasonal pollen that will be present in their geographic area during study participation are NOT eligible for randomization.
Randomization Criteria
At Visit 2, the subject must meet the following criteria:
Exclusion Criteria:
Subjects meeting any of the following criteria must not be enrolled in the study:
NOTE: Subjects will be allowed to use short-acting inhaled beta2 agonists ONLY on an as needed basis.
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | FFU111439 |
Study First Received: | January 24, 2008 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00609674 |
Health Authority: | United States: Food and Drug Administration |
Perennial allergic rhinitis; fluticasone furoate nasal spray |
Hypersensitivity Otorhinolaryngologic Diseases Respiratory Tract Infections Respiratory Tract Diseases Rhinitis, Allergic, Perennial |
Hypersensitivity, Immediate Fluticasone Rhinitis Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Immune System Diseases Physiological Effects of Drugs Anti-Asthmatic Agents Anti-Allergic Agents Nose Diseases |
Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents Dermatologic Agents |