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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00116818 |
The purpose of this study is to assess the effect of an aqueous nasal spray investigational compound compared to placebo on the hypothalamic pituitary adrenocortical (HPA) axis system in adolescents and adults 12 to 65 years of age with perennial allergic rhinitis. This study can last up to 6 weeks and you will come to the clinic up to 7 times. Clinic visits include physical examinations, vital sign assessments, clinical laboratory assessments, ECGs and allergy skin testing. You will need to complete a daily diary card and spend the night in the clinic on 2 occasions to collect urine and blood samples over 24 hour periods.
Condition | Intervention | Phase |
---|---|---|
Perennial Allergic Rhinitis |
Drug: GW685698X aqueous nasal spray |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety Study |
Official Title: | See Detailed Description |
Estimated Enrollment: | 90 |
Study Start Date: | January 2005 |
Study Completion Date: | May 2005 |
Primary Completion Date: | May 2005 (Final data collection date for primary outcome measure) |
A randomized, double-blind, parallel group, placebo and active (prednisone) controlled, 6-week study of the effect of GW685698X aqueous nasal spray 100mcg QD on the hypothalamic pituitary adrenocortical (HPA) axis in adolescents and adults 12 to 65 years of age with perennial allergic rhinitis (PAR).
Ages Eligible for Study: | 12 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
United States, Texas | |
GSK Investigational Site | |
San Antonio, Texas, United States, 78229 | |
Canada, Ontario | |
GSK Investigational Site | |
Mississauga, Ontario, Canada, L4W 1N2 |
Study Director: | GSK Clinical Trials, MD, MBA | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | FFR20002 |
Study First Received: | June 30, 2005 |
Last Updated: | October 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00116818 History of Changes |
Health Authority: | United States: Food and Drug Administration |
perennial allergic rhinitis intranasal corticosteroid GW685698X HPA axis function |
Hypersensitivity Otorhinolaryngologic Diseases Respiratory Tract Infections Respiratory Tract Diseases |
Rhinitis, Allergic, Perennial Hypersensitivity, Immediate Rhinitis Respiratory Hypersensitivity |
Hypersensitivity Otorhinolaryngologic Diseases Immune System Diseases Respiratory Tract Infections Respiratory Tract Diseases |
Rhinitis, Allergic, Perennial Hypersensitivity, Immediate Rhinitis Nose Diseases Respiratory Hypersensitivity |