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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00570492 |
Purpose
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 |
|---|---|---|
|
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) |
Eligibility| 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:
Contacts and Locations| Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Show 73 Study Locations| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | FFR101782 |
| Study First Received: | December 6, 2007 |
| Last Updated: | October 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00570492 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
fluticasone furoate nasal spray allergic rhinitis growth |
|
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 |