Perennial Allergic Rhinitis Study In Pediatric Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00108914
First received: April 20, 2005
Last updated: May 16, 2013
Last verified: June 2011
  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
Rhinitis, Allergic, Perennial
Drug: GW685698X
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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
Intervention Details:
    Drug: GW685698X
    Other Name: GW685698X
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Georgia
GSK Investigational Site
Gainesville, Georgia, United States, 30501
GSK Investigational Site
Lawrenceville, Georgia, United States, 30045
GSK Investigational Site
Stockbridge, Georgia, United States, 30281
United States, North Carolina
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
Argentina
GSK Investigational Site
Nueve de Julio, Buenos Aires, Argentina, B6500BWQ
GSK Investigational Site
Rosario, Santa Fe, Argentina, 2000
GSK Investigational Site
Buenos Aires, Argentina, 1425
GSK Investigational Site
Santa Fe, Argentina, 3000
Chile
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile
GSK Investigational Site
Viña del Mar, Valparaíso, Chile
Mexico
GSK Investigational Site
Mexico, Mexico, 6720
GSK Investigational Site
Mexico, Mexico, 04530
GSK Investigational Site
Monterrey, N.L, Mexico, 64460
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00108914     History of Changes
Other Study ID Numbers: FFR30008
Study First Received: April 20, 2005
Last Updated: May 16, 2013
Health Authority: Slovakia: State Institute for Drug Control
Finland: Finnish Medicines Agency
Mexico: National Institute of Public Health, Health Secretariat
United States: Food and Drug Administration
Italy: Ministry of Health

Keywords provided by GlaxoSmithKline:
pediatric
Perennial allergic rhinitis

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on October 30, 2014