A Study Of GW685698X For The Treatment Of Perennial Allergic Rhinitis In Pediatrics

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Rhinitis, Allergic, Perennial

Treatments: Drug: GW685698X aqueous nasal spray

Study type: Interventional

Funder types: Industry

Identifiers

NCT00116883

FFR100012

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 2 to 11 years old

Volunteers: No Healthy 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

• Significant concurrent medical conditions.
• Certain medications such as corticosteroids and allergy medications.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: GW685698X aqueous nasal spray