Perennial Allergic Rhinitis Study In Pediatric Subjects

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: April 20, 2005
Last updated: April 14, 2015
Last verified: April 2015
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.

Enrollment: 558
Study Start Date: February 2005
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
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)

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

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
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Please refer to this study by its identifier: NCT00108914

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
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
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile
GSK Investigational Site
Viña del Mar, Valparaíso, Chile
GSK Investigational Site
Mexico, Mexico, 04530
GSK Investigational Site
Mexico, Mexico, 6720
GSK Investigational Site
Monterrey, N.L, Mexico, 64460
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Máspero J, Rosenblut A, Finn A, J Lim J, Wu W, Philpot E. Safety of fluticasone furoate* nasal spray in children with perennial allergic rhinitis (*USAN approved name). Allergy 2007;62(Suppl. 83): 381 (abstract).
Máspero JF, Rosenblut A, Finn A, Lim J, Wu W, Faris M, Philpot E. Once-daily fluticasone furoate nasal spray (FF) is safe and effective in the long-term treatment of perennial allergic rhinitis (PAR) in children ages 2 to 11 years. J Allergy Clin Immunol.

Responsible Party: GlaxoSmithKline Identifier: NCT00108914     History of Changes
Other Study ID Numbers: FFR30008 
Study First Received: April 20, 2005
Last Updated: April 14, 2015
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:
Perennial allergic rhinitis

Additional relevant MeSH terms:
Rhinitis, Allergic, Perennial
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases processed this record on August 30, 2016