Study Of Perennial Allergic Rhinitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00358475
First received: July 27, 2006
Last updated: April 11, 2013
Last verified: May 2012
  Purpose

This study was designed to assess safety of an investigational nasal spray in the treatment of perennial allergic rhinitis. Perennial allergic rhinitis is triggered by house dust, mite and mold etc. Typical symptoms are sneezing, nasal congestion and pruritus and rhinorrhea.


Condition Intervention Phase
Rhinitis, Allergic, Seasonal
Drug: GW685698
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Perennial Allergic Rhinitis -Long Term Treatment Study-

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Adverse events and laboratory blood test

Secondary Outcome Measures:
  • Change of nasal symptom score

Enrollment: 65
Study Start Date: June 2005
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: GW685698
    Other Name: GW685698
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Informed consent.
  • Outpatient.
  • Diagnosis of perennial allergic rhinitis with symptoms.
  • Able to comply with study procedures.

Exclusion criteria:

  • Significant concomitant medical condition.
  • Use of corticosteroids/allergy medications.
  • Laboratory abnormality.
  • Positive pregnancy test.
  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: NCT00358475

Locations
Spain
GSK Investigational Site
Unknown, Spain
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00358475     History of Changes
Other Study ID Numbers: FFR100688
Study First Received: July 27, 2006
Last Updated: April 11, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
perennial allergic rhinitis

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

ClinicalTrials.gov processed this record on September 18, 2014