Perennial Allergic Rhinitis Study In Pediatric Subjects - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00108914

Purpose

The purpose of this study is to determine if the investigational drug is effective and safe in children with perennial allergic rhinitis.

Condition	Intervention	Phase
Perennial Allergic Rhinitis	Drug: GW685698X	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	See Detailed Description

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Improvement in daily, reflective total nasal symptom scores after first 4-week treatment period in subjects ages 6 to <12 years.

Secondary Outcome Measures:

Improvement in AM, pre-dose, instantaneous total nasal symptom scores after first 4-week treatment period, overall evaluation of response to therapy for the first 4-week treatment period for subjects ages 6 to <12 years.

Estimated Enrollment:	576
Study Start Date:	February 2005

Detailed Description:

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 50mcg and 100mcg for 12 Weeks in Pediatric Subjects Ages 2 to <12 Years with Perennial Allergic Rhinitis (PAR)

Eligibility

Ages Eligible for Study:	2 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Diagnosis of perennial allergic rhinitis.

Exclusion criteria:

Have significant concomitant medical conditions.
Use of corticosteroids or other allergy medications during the study.
Have abnormal ECG.
Have laboratory abnormality.
Have abnormal eye exam.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108914

Show 65 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	FFR30008
Study First Received:	April 20, 2005
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00108914
Health Authority:	United States: Food and Drug Administration; Mexico: National Institute of Public Health, Health Secretariat; Slovakia: State Institute for Drug Control; Finland: National Agency for Medicines; Italy: Ministry of Health; United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Perennial allergic rhinitis
pediatric

Study placed in the following topic categories:

Hypersensitivity
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

Rhinitis, Allergic, Perennial
Hypersensitivity, Immediate
Rhinitis
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases
Nose Diseases

ClinicalTrials.gov processed this record on January 15, 2009