NCT00116883
Completed
Phase 3
A Randomized, Double-blind, Parallel Group, Placebo Controlled, 6-week Study of the Effect of GW685698X Aqueous Nasal Spray 100mcg QD on the Hypothalamic Pituitary Adrenocortical (HPA) Axis in Children 2 to 11 Years of Age With Perennial Allergic Rhinitis (PAR).
ConditionsRhinitis, Allergic, Perennial
InterventionsGW685698X aqueous nasal spray
Overview
- Phase
- Phase 3
- Intervention
- GW685698X aqueous nasal spray
- Conditions
- Rhinitis, Allergic, Perennial
- Sponsor
- GlaxoSmithKline
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm 1
Intervention: GW685698X aqueous nasal spray
Outcomes
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
- Results of adverse event, laboratory, nasal examination, vital sign, ECG and pharmacokinetic assessments.
Study Sites (1)
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