Not Signed In -
Cromolyn Nasal Spray |
Nasalcrom |
Clinical Trial: A Study of GW685698X for the Treatment of Perennial Allergic Rhinitis in Adolescents and Adults
This study is no longer recruiting patients.
|
Purpose
The purpose of this study is to assess the effect of an aqueous nasal spray investigational compound GW685698X 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.
| Condition | Intervention | Phase |
|---|---|---|
| Rhinitis, Allergic, Perennial | Drug: GW685698X aqueous nasal spray | Phase III |
MedlinePlus related topics: Allergy; Nose Disorders; Respiratory Diseases
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Official Title: 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)
Further Study Details:
Primary Outcomes: 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
Secondary Outcomes: Adverse events; Laboratory results; Nasal examination; Vital signs; ECG assessments; Pharmacokinetic assessments
Expected Total Enrollment: 90
Secondary Outcomes: Adverse events; Laboratory results; Nasal examination; Vital signs; ECG assessments; Pharmacokinetic assessments
Expected Total Enrollment: 90
Study start: January 2005
Eligibility
Ages Eligible for Study: 12 Years - 65 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Must have a 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.
- Must be literate.
Exclusion Criteria:
- Use of tobacco products.
- Work a rotating shift.
- Significant concurrent medical conditions.
- Use of certain medications such as corticosteroids and allergy medications during the study.
Location Information
Texas
Paul H. Ratner, San Antonio, Texas, 78229, United States
Canada, Ontario
GSK Clinical Trials Call Center, Mississauga, Ontario, L4W 1N2, Canada
Study chairs or principal investigators
GSK Clinical Trials, Study Director, GlaxoSmithKline
More Information
Study ID Numbers: FFR20002
Last Updated: August 1, 2005
Record first received: June 30, 2005
ClinicalTrials.gov Identifier: NCT00116818
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-02
Last Updated: August 1, 2005
Record first received: June 30, 2005
ClinicalTrials.gov Identifier: NCT00116818
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-02
Resources
- Cromolyn Nasal Spray (Drug Digest)
- Nasalcrom (Drug Digest)
email this page
print this page
bookmark this page
feedback on this page
