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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00570492 |
The primary objective of this study is to characterize, as accurately as possible, the estimation of the difference in pre-pubescent growth velocities between subjects treated continuously for one year with FFNS 110mcg QD, the highest dose approved for pediatric use in the US, and placebo nasal spray as determined by stadiometry.
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 Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate the Effects of a One-Year Course of Fluticasone Furoate Nasal Spray 110mcg QD on Growth in Pre-Pubescent, Pediatric Subjects With Perennial Allergic Rhinitis |
Estimated Enrollment: | 450 |
Study Start Date: | November 2007 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 5 Years to 8 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Note: Subjects who meet the above criteria and who may also have seasonal allergic rhinitis (SAR) and/or non-allergic rhinitis (NAR) are eligible for randomization.
Exclusion criteria:
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: | FFR101782 |
Study First Received: | December 6, 2007 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00570492 |
Health Authority: | United States: Food and Drug Administration |
fluticasone furoate nasal spray allergic rhinitis growth |
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 |