Last updated: 11/07/2018 16:42:39

Study of GW685698X In Patients With Seasonal Allergic Rhinitis

GSK study ID
FFR100652
See study documents
Clinicaltrials.gov ID
NCT00363740
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Clinical Evaluation of GW685698 for Seasonal Allergic Rhinitis -A Placebo-controlled Study to Determine the Non-inferiority of GW685698 over Fluticasone Propionate Using a Double-blind Manner-
Trial description: This study was designed to compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray and commonly used drug 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. Typical symptoms are sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: GW685698X Aqueous Nasal Spray
Enrollment:
38
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Keisuke Masuyama, Yoriko Morioka, Terufumi Hara. Drug Use Investigation on Fluticasone Furoate (Allermist®) 27.5 µg 56 Metered Nasal Spray. Allergol Immunol. 2012;19(12):88-101.
Medical condition
Rhinitis, Allergic, Seasonal
Product
fluticasone furoate
Collaborators
Not applicable
Study date(s)
February 2005 to April 2005
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
16+ years
Accepts healthy volunteers
No
  • Informed consent
  • Outpatient
  • Significant concomitant medical condition
  • Use of corticosteroids/allergy medications
Inclusion and exclusion criteria
Inclusion criteria:
  • Informed consent
  • Outpatient
  • Diagnosis of seasonal 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
  • Allergy to any component of investigational product

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Unknown, Japan
Status
Study Complete
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Study documents

Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-13-04

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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