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

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.
 
ClinicalTrials.gov Identifier: NCT00116818
Recruitment Status : Completed
First Posted : July 1, 2005
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rhinitis, Allergic, Perennial Drug: GW685698X aqueous nasal spray Phase 3

Detailed Description:
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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : January 2005
Actual Primary Completion Date : May 2005
Actual Study Completion Date : May 2005
Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1 Drug: GW685698X aqueous nasal spray


Outcome Measures
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Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Results of adverse event, laboratory, nasal examination, vital sign, ECG and pharmacokinetic assessments.

Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00116818


Locations
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United States, Texas
GSK Investigational Site
San Antonio, Texas, United States, 78229
Canada, Ontario
GSK Investigational Site
Mississauga, Ontario, Canada, L4W 1N2
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Additional Information:

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: FFR20002
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: FFR20002
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: FFR20002
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: FFR20002
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: FFR20002
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: FFR20002
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: FFR20002
For additional information about this study please refer to the GSK Clinical Study Register

Publications of Results:
Patel D, Ratner P, Clements D, Wu W, Faris M, Philpot E. Lack of effect on hypothalamic-pituitary-adrenal (HPA) axis function by once-daily fluticasone furoate* nasal spray (FFNS) 110 mcg in adolescents and adults with perennial allergic rhinitis (PAR).
Patel P, Ratner P, Clements D, Wu W, Philpot E. Twenty-four hour serum and urine cortisol data support hypothalamic-pituitary adrenocortical axis safety of once-daily fluticasone furoate*nasal spray 110mcg in adolescents and adults with perennial allerg

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00116818    
Other Study ID Numbers: FFR20002
First Posted: July 1, 2005    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: September 2016
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
intranasal corticosteroid
HPA axis function
GW685698X
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Respiratory Tract Infections
Infections
Nose Diseases
 Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases