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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00609674 |
Purpose
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 |
|---|---|---|
|
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) |
Eligibility| 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.
Contacts and Locations
Hide Study Locations| United States, Maryland | |
| GSK Investigational Site | |
| Baltimore, Maryland, United States, 21236 | |
| GSK Investigational Site | |
| Wheaton, Maryland, United States, 20902 | |
| United States, Massachusetts | |
| GSK Investigational Site | |
| North Dartmouth, Massachusetts, United States, 02747 | |
| United States, Minnesota | |
| GSK Investigational Site | |
| Minneapolis, Minnesota, United States, 55402 | |
| GSK Investigational Site | |
| Plymouth, Minnesota, United States, 55441 | |
| United States, Missouri | |
| GSK Investigational Site | |
| St. Louis, Missouri, United States, 63141 | |
| United States, Nebraska | |
| GSK Investigational Site | |
| Lincoln, Nebraska, United States, 68505 | |
| United States, New Jersey | |
| GSK Investigational Site | |
| Ocean, New Jersey, United States, 07712 | |
| United States, Ohio | |
| GSK Investigational Site | |
| Canton, Ohio, United States, 44718 | |
| United States, Rhode Island | |
| GSK Investigational Site | |
| Providence, Rhode Island, United States, 02906 | |
| United States, Vermont | |
| GSK Investigational Site | |
| South Burlington, Vermont, United States, 05403 | |
| United States, Wisconsin | |
| GSK Investigational Site | |
| Greenfield, Wisconsin, United States, 53228 | |
| Canada, Manitoba | |
| GSK Investigational Site | |
| Winnipeg, Manitoba, Canada, R2M 5L9 | |
| Canada, Newfoundland and Labrador | |
| GSK Investigational Site | |
| Saint John's, Newfoundland and Labrador, Canada, A1A 3R5 | |
| Canada, Ontario | |
| GSK Investigational Site | |
| Toronto, Ontario, Canada, M9W 4L6 | |
| GSK Investigational Site | |
| Kanata, Ontario, Canada, K2L 3C8 | |
| GSK Investigational Site | |
| Mississauga, Ontario, Canada, L5A 3V4 | |
| GSK Investigational Site | |
| Ottawa, Ontario, Canada, K1Y 4G2 | |
| GSK Investigational Site | |
| Hamilton, Ontario, Canada, L8N 3Z5 | |
| Canada, Quebec | |
| GSK Investigational Site | |
| Quebec City, Quebec, Canada, G1V 4M6 | |
| GSK Investigational Site | |
| Trois Rivières, Quebec, Canada, G8T 7A1 | |
| Canada, Saskatchewan | |
| GSK Investigational Site | |
| Saskatoon, Saskatchewan, Canada, S7H 0V1 | |
| Estonia | |
| GSK Investigational Site | |
| Tallinn, Estonia, 13419 | |
| GSK Investigational Site | |
| Tartu, Estonia, 51014 | |
| Germany | |
| GSK Investigational Site | |
| Berlin, Germany, 10787 | |
| Germany, Niedersachsen | |
| GSK Investigational Site | |
| Hannover, Niedersachsen, Germany, 30159 | |
| Germany, Sachsen-Anhalt | |
| GSK Investigational Site | |
| Magdeburg, Sachsen-Anhalt, Germany, 39112 | |
| Hungary | |
| GSK Investigational Site | |
| Budapest, Hungary, 1116 | |
| GSK Investigational Site | |
| Budapest, Hungary, 1148 | |
| GSK Investigational Site | |
| Budapest, Hungary, 1204 | |
| GSK Investigational Site | |
| Budapest, Hungary, 1015 | |
| Russian Federation | |
| GSK Investigational Site | |
| Moscow, Russian Federation, 123095 | |
| GSK Investigational Site | |
| Moscow, Russian Federation, 115478 | |
| GSK Investigational Site | |
| Moscow, Russian Federation, 115446 | |
| GSK Investigational Site | |
| Saint-Petersburg, Russian Federation, 190013 | |
| Slovakia | |
| GSK Investigational Site | |
| Banska Bystrica, Slovakia, 975 17 | |
| GSK Investigational Site | |
| Bratislava, Slovakia, 812 50 | |
| GSK Investigational Site | |
| Presov, Slovakia, 080 01 | |
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | FFU111439 |
| Study First Received: | January 24, 2008 |
| Last Updated: | January 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00609674 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Perennial allergic rhinitis; fluticasone furoate nasal spray |
|
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 |