A Study of GW685698X for the Treatment Of Perennial Allergic Rhinitis in Adolescents and Adults
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Purpose
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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | See Detailed Description |
- HPA axis function at baseline and after 6 weeks of treatment as measured by 24 hour urine and serial serum cortisol assessments in domiciled subjects
- Results of adverse event, laboratory, nasal examination, vital sign, ECG and pharmacokinetic assessments.
| 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) |
-
Drug: GW685698X aqueous nasal spray
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).
Eligibility| Ages Eligible for Study: | 12 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Diagnosis and history of perennial allergic rhinitis.
- Must be willing to stay overnight in the clinic at the beginning and end of the study for the collection of urine and blood samples over 24 hours.
- Must comply with all study procedures and be literate.
Exclusion criteria:
- Use of tobacco products.
- Work a rotating shift.
- Significant concurrent medical conditions.
- Certain medications such as corticosteroids and allergy medications.
Contacts and Locations| 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 |
More Information
No publications provided by GlaxoSmithKline
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Study Director, GSK |
| ClinicalTrials.gov Identifier: | NCT00116818 History of Changes |
| Other Study ID Numbers: | FFR20002 |
| Study First Received: | June 30, 2005 |
| Last Updated: | October 13, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
|
perennial allergic rhinitis intranasal corticosteroid GW685698X HPA axis function |
Additional relevant MeSH terms:
|
Rhinitis Rhinitis, Allergic, Perennial Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013