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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00682643 |
The purpose of this study is to assess long-term ocular safety of fluticasone furoate nasal spray in adult and adolescent subjects diagnosed with perennial allergic rhinitis.
Condition | Intervention | Phase |
---|---|---|
Perennial Allergic Rhinitis (PAR) |
Drug: fluticasone furoate nasal spray |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter, Two-Year Study to Evaluate the Ocular Safety of Once-Daily, Fluticasone Furoate Nasal Spray 110mcg in Adults and Adolescents 12 Years of Age and Older With Perennial Allergic Rhinitis |
Estimated Enrollment: | 525 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | April 2011 |
Estimated Primary Completion Date: | April 2011 (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:
Informed consent
•Subject has provided an appropriately signed and dated informed consent. An appropriately signed and dated assent must be obtained from the parents or guardian if the subject is a child under 18 years of age.
Outpatient
•Subject is treatable on an outpatient basis.
Age
•12 years of age and older at Visit 2
Male or eligible female Female subjects should not be enrolled if they plan to become pregnant during the time of study participation.
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:
Diagnosis of PAR to include:
A positive skin test (by prick method) response to appropriate perennial allergen (house dust mites, animal dander, mold, or cockroach) within last 12 months prior to Visit 1 or at Visit 1.
A positive skin test is defined as a wheal ³3mm larger than the diluent control for prick testing.
•Two year medical history and past treatment of PAR (written or verbal confirmation) which includes perennial, i.e., year-round, symptoms. PAR symptoms could include nasal congestion, rhinorrhea, nasal itching and sneezing.
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 and who also may have seasonal allergic rhinitis (SAR) and/or perennial non-allergic rhinitis (PNAR) are eligible for randomization.
Environment
•Subject must be symptomatic to appropriate perennial allergen (animal dander, house dust mites, cockroach, mold) and willing to maintain, as much as possible, the same environment throughout the study.
Exclusion Criteria:
Subjects meeting any of the following criteria must not be enrolled in the study:
Significant concomitant medical conditions, defined as but not limited to:
NOTE: Subjects will be allowed to use short-acting inhaled beta2 agonists ONLY on an as needed basis.
Use of corticosteroids, defined as:
Use of other allergy medications within the timeframe indicated relative to Visit 1
Allergy/Intolerance
•Known hypersensitivity to corticosteroids or any excipients
Clinical trial/experimental medication experience
Positive urine pregnancy test or female who is breastfeeding
•Has a positive or inconclusive pregnancy test at Visit 1 or Visit 2
Tobacco use
•Subject currently uses smoking products including cigarettes, cigars, and pipe or chewing tobacco, or has used these products in the last 6 months
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | FFR110537 |
Study First Received: | May 20, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00682643 |
Health Authority: | United States: Food and Drug Administration |
Perennial Allergic Rhinitis fluticasone furoate ocular |
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 |