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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: January 18, 2017
Last verified: January 2017
  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
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Two Week Randomized, Double Blind Placebo Controlled, Parallel Group Study of GW685698X Aqueous Nasal Spray 100mcg and 50mcg QD in Pediatric Subjects With Perennial Allergic Rhinitis

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)
  Eligibility

Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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

  Show 66 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
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.

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: FFR30008
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: FFR30008
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: FFR30008
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: FFR30008
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: FFR30008
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: FFR30008
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: FFR30008
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00108914     History of Changes
Other Study ID Numbers: FFR30008
Study First Received: April 20, 2005
Last Updated: January 18, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Perennial allergic rhinitis
pediatric

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

ClinicalTrials.gov processed this record on August 17, 2017