Rhinitis, Allergic, Perennial
Conditions
Keywords
GW685698X, perennial allergic rhinitis, pediatric, intranasal corticosteroid, HPA axis function
Brief summary
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 children 2 to 11 years of age with perennial allergic rhinitis.
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 11 Years
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
* Significant concurrent medical conditions. * Certain medications such as corticosteroids and allergy medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Results of adverse event, laboratory, nasal examination, vital sign, ECG and pharmacokinetic assessments. | — |
Countries
United States
Outcome results
None listed