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Study In Adults And Adolescents With Seasonal Allergic Rhinitis.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00225823
First received: September 22, 2005
Last updated: September 13, 2016
Last verified: September 2016
  Purpose
Compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray in the treatment of seasonal allergic rhinitis. Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Commonly referred to as 'hay fever', it is characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes.

Condition Intervention Phase
Rhinitis, Allergic, Seasonal
Drug: GW685698X
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multicentre Two Week Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis in Europe

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Mean change from baseline over the entire treatment period in daily, reflective, total nasal symptom scores (rTNSS).

Secondary Outcome Measures:
  • Mean change from baseline over the entire tx period in AM, pre-dose iTNS. Mean change from baseline over the entire treatment period in rTOSS. Overall evaluation of response to therapy.

Enrollment: 288
Study Start Date: May 2005
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Informed consent.
  • Must be an outpatient.
  • Females must be using appropriate contraception.
  • Must have diagnosis of seasonal allergic rhinitis, adequate exposure to allergen.
  • Must be able to comply with study procedures.
  • Must be literate.

Exclusion criteria:

  • A significant concomitant medical condition.
  • Use of corticosteroids or allergy or medications or tobacco.
  • Clinically significant abnormal ECG.
  • Laboratory abnormality.
  • Positive pregnancy test.
  • Allergy to any component of the investigational product.
  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: NCT00225823

Locations
Estonia
GSK Investigational Site
Tallinn, Estonia, 13419
GSK Investigational Site
Tartu, Estonia, 51014
Latvia
GSK Investigational Site
Liepaja, Latvia, LV3401
GSK Investigational Site
Riga, Latvia, LV 1001
GSK Investigational Site
Riga, Latvia, LV 1002
GSK Investigational Site
Riga, Latvia, LV 1003
GSK Investigational Site
Riga, Latvia, LV 1004
Lithuania
GSK Investigational Site
Kaunas, Lithuania, LT-50009
GSK Investigational Site
Kaunas, Lithuania, LT-50425
GSK Investigational Site
Siauliai, Lithuania, LT-78242
GSK Investigational Site
Vilnius, Lithuania, LT-08661
Netherlands
GSK Investigational Site
Amsterdam, Netherlands, 1105 AZ
GSK Investigational Site
Arnhem, Netherlands, 6824 BJ
GSK Investigational Site
Assen, Netherlands, 9401 RK
GSK Investigational Site
Leeuwarden, Netherlands, 8934 AD
GSK Investigational Site
Schiedam, Netherlands, 3116 BA
GSK Investigational Site
Tilburg, Netherlands, 5038 NM
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 115446
GSK Investigational Site
Saint-Petersburg, Russian Federation, 190013
GSK Investigational Site
Volgograd, Russian Federation, 400130
Sweden
GSK Investigational Site
Lund, Sweden, SE-221 85
GSK Investigational Site
Malmö, Sweden, SE-211 36
GSK Investigational Site
Västerås, Sweden, SE-721 89
GSK Investigational Site
Ängelholm, Sweden, SE-262 81
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: FFR103184
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: FFR103184
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: FFR103184
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: FFR103184
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: FFR103184
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: FFR103184
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: FFR103184
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00225823     History of Changes
Other Study ID Numbers: FFR103184 
Study First Received: September 22, 2005
Last Updated: September 13, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
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:
Seasonal Allergic Rhinitis Intranasal Corticosteroid

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

ClinicalTrials.gov processed this record on September 28, 2016