A Study To Evaluate The Efficacy And Safety Of A Once-Daily Investigational Nasal Spray In Adults And Adolescents With Perennial Allergic Rhinitis (PAR).

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Rhinitis, Allergic, Perennial

Treatments: Drug: GW685698X

Study type: Interventional

Funder types: Industry

Identifiers

NCT00103454

FFR30002

Details and patient eligibility

About

The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with perennial allergic rhinitis (PAR).

Full description

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 4 Weeks in Adult and Adolescent Subjects (12 years of age and older) with Perennial Allergic Rhinitis (PAR)

Enrollment: 288 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of perennial allergic rhinitis (PAR).
• Must comply with study procedures and be literate.

Exclusion criteria

• Significant concomitant medical conditions.
• Use of corticosteroids.
• Use of allergy medications and some other medications during the study.
• Current tobacco use.
• Clinically significant abnormal ECG or laboratory abnormality.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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288 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: GW685698X