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A Study of GW685698X for the Treatment Of Perennial Allergic Rhinitis in Adolescents and Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00116818
First Posted: July 1, 2005
Last Update Posted: September 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
June 30, 2005
July 1, 2005
September 15, 2016
January 2005
May 2005   (Final data collection date for primary outcome measure)
HPA axis function at baseline and after 6 weeks of treatment as measured by 24 hour urine and serial serum cortisol assessments in domiciled subjects
Same as current
Complete list of historical versions of study NCT00116818 on ClinicalTrials.gov Archive Site
Results of adverse event, laboratory, nasal examination, vital sign, ECG and pharmacokinetic assessments.
  • Adverse events
  • Laboratory results
  • Nasal examination
  • Vital signs
  • ECG assessments
  • Pharmacokinetic assessments
Not Provided
Not Provided
 
A Study of GW685698X for the Treatment Of Perennial Allergic Rhinitis in Adolescents and Adults
A Randomized, Double-blind, Parallel Group, Placebo and Active (Prednisone) Controlled, 6-week Study of the Effect of Fluticasone Furoate Aqueous Nasal Spray 100mcg QD on the Hypothalamic Pituitary Adrenocortical (HPA) Axis in Adolescents and Adults 12 to 65 Years of Age With Perennial Allergic Rhinitis (PAR)
The purpose of this study is to assess the effect of an aqueous nasal spray investigational compound compared to placebo on the hypothalamic pituitary adrenocortical (HPA) axis system in adolescents and adults 12 to 65 years of age with perennial allergic rhinitis. This study can last up to 6 weeks and you will come to the clinic up to 7 times. Clinic visits include physical examinations, vital sign assessments, clinical laboratory assessments, ECGs and allergy skin testing. You will need to complete a daily diary card and spend the night in the clinic on 2 occasions to collect urine and blood samples over 24 hour periods.
A randomized, double-blind, parallel group, placebo and active (prednisone) controlled, 6-week study of the effect of GW685698X aqueous nasal spray 100mcg QD on the hypothalamic pituitary adrenocortical (HPA) axis in adolescents and adults 12 to 65 years of age with perennial allergic rhinitis (PAR).
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Rhinitis, Allergic, Perennial
Drug: GW685698X aqueous nasal spray
Experimental: Arm 1
Intervention: Drug: GW685698X aqueous nasal spray

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
May 2005
May 2005   (Final data collection date for primary outcome measure)

Inclusion criteria:

  • Diagnosis and history of perennial allergic rhinitis.
  • Must be willing to stay overnight in the clinic at the beginning and end of the study for the collection of urine and blood samples over 24 hours.
  • Must comply with all study procedures and be literate.

Exclusion criteria:

  • Use of tobacco products.
  • Work a rotating shift.
  • Significant concurrent medical conditions.
  • Certain medications such as corticosteroids and allergy medications.
Sexes Eligible for Study: All
12 Years to 65 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00116818
FFR20002
Not Provided
Not Provided
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.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP