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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
Outpatient
Age
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.
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
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
Clinical trial/experimental medication experience
Positive urine pregnancy test or female who is breastfeeding
Affiliation with investigational site
Tobacco use
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: | March 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00682643 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Perennial Allergic Rhinitis fluticasone furoate ocular |
Anti-Inflammatory Agents Otorhinolaryngologic Diseases Anti-Asthmatic Agents Rhinitis Anti-Allergic Agents Hypersensitivity Rhinitis, Allergic, Perennial |
Respiratory Tract Diseases Respiratory Tract Infections Hypersensitivity, Immediate Fluticasone Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Otorhinolaryngologic Diseases Immune System Diseases Physiological Effects of Drugs Anti-Asthmatic Agents Rhinitis Anti-Allergic Agents Pharmacologic Actions Nose Diseases Hypersensitivity |
Rhinitis, Allergic, Perennial Respiratory Tract Diseases Respiratory Tract Infections Autonomic Agents Therapeutic Uses Hypersensitivity, Immediate Fluticasone Peripheral Nervous System Agents Dermatologic Agents Bronchodilator Agents Respiratory Hypersensitivity |