A Study of GW685698X for the Treatment Of Perennial Allergic Rhinitis in Adolescents and Adults
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
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).
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
90 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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