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: FF; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00289198

FFR106080

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 6 Weeks in Adult and Adolescent Subjects 12 years of Age and Older with Perennial Allergic Rhinitis (PAR)

Enrollment: 301 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 and other identified medications during the study.
• Current tobacco use or tobacco use within the past year.
• Exposure to an investigational study drug within the past 12 months.
• Clinically significant abnormal electrocardiograms (ECG) or laboratory abnormality.

Trial design

301 participants in 2 patient groups, including a placebo group

Fluticasone furoate

Experimental group

Description:

Participants were instructed to administer two sprays into each nostril once daily every morning of fluticasone furoate 110 μg

Treatment:

Drug: FF

Placebo

Placebo Comparator group

Description:

Participants were instructed to administer two sprays into each nostril once daily every morning of placebo

Treatment:

Drug: Placebo