Study In Adults And Adolescents With Seasonal Allergic Rhinitis

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00225823
First received: September 22, 2005
Last updated: October 1, 2010
Last verified: October 2010
  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
Hayfever Allergic Rhinitis Seasonal Rhinitis
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: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Two Week Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100 Mcg 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.

Estimated 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
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 Clinical Trials Call Center
Tallinn, Estonia, 13419
GSK Clinical Trials Call Center
Tartu, Estonia, 51014
Latvia
GSK Clinical Trials Call Center
Liepaja, Latvia, LV 3401
GSK Clinical Trials Call Center
Riga, Latvia, LV 1001
GSK Clinical Trials Call Center
Riga, Latvia, LV 1004
GSK Clinical Trials Call Center
Riga, Latvia, LV 1002
GSK Clinical Trials Call Center
Riga, Latvia, LV 1003
Lithuania
GSK Clinical Trials Call Center
Kaunas, Lithuania, LT-50009
GSK Clinical Trials Call Center
Kaunas, Lithuania, 50425
GSK Clinical Trials Call Center
Vilnius, Lithuania, LT-10200
GSK Clinical Trials Call Center
Vilnius, Lithuania, LT-09125
GSK Clinical Trials Call Center
Vilnius, Lithuania, LT-08661
Netherlands
GSK Clinical Trials Call Center
Amsterdam, Netherlands, 1105 AZ
GSK Clinical Trials Call Center
Arnhem, Netherlands, 6824 BJ
GSK Clinical Trials Call Center
Assen, Netherlands, 9401 RK
GSK Clinical Trials Call Center
Haarlem, Netherlands, 2035 RC
GSK Clinical Trials Call Center
Leeuwarden, Netherlands, 8934 AD
GSK Clinical Trials Call Center
Schiedam, Netherlands, 3116 BA
GSK Clinical Trials Call Center
Tilburg, Netherlands, 5038 NM
Russian Federation
GSK Clinical Trials Call Center
Moscow, Russian Federation, 115446
GSK Clinical Trials Call Center
Saint-Petersburg, Russian Federation, 190013
GSK Clinical Trials Call Center
Volgograd, Russian Federation, 400130
Sweden
GSK Clinical Trials Call Center
Angelhom, Sweden, SE-262 81
GSK Clinical Trials Call Center
Lund, Sweden, SE-221 85
GSK Clinical Trials Call Center
Malmo, Sweden, SE-211 36
GSK Clinical Trials Call Center
Vasteras, Sweden, SE-721 89
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00225823     History of Changes
Other Study ID Numbers: FFR103184
Study First Received: September 22, 2005
Last Updated: October 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Seasonal Allergic Rhinitis Intranasal Corticosteroid

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

ClinicalTrials.gov processed this record on July 23, 2014