Last updated: 11/04/2018 06:56:14

Study In Adolescent And Adult Subjects 12 Years Of Age And Older With Seasonal Allergic Rhinitis To Assess Onset of Action

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GSK study ID
FFR101816
See study documents
Clinicaltrials.gov ID
NCT00118729
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: A Randomized, Double Blind, Placebo-Controlled, Single-Dose, Parallel-Group Study to Evaluate the Onset of Action of a Single Dose of Intranasal GW685698X Aqueous Nasal Spray 100mcg in Adolescent and Adult Subjects (12 years of age and older) with Seasonal Allergic Rhinitis Exposed to Ragweed Pollen in an Allergen Challenge Chamber
Trial description: 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. The purpose of this study is to evaluate the onset of action of an investigational nasal spray, GW685698X aqueous nasal spray, versus vehicle placebo nasal spray in the treatment of seasonal allergic rhinitis caused by ragweed following a single dose of treatment in controlled pollen concentrations in an allergen challenge chamber.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Mean change from baseline in subject-rated total nasal symptom score following a single dose of GW685698X aqueous nasal spray during exposure to ragweed pollen over a 12-hour period.

Timeframe: N/A

Secondary outcomes:

Change from baseline in the individual nasal symptom scores of rhinorrhea, nasal congestion, nasal itching and sneezing, assessed hourly during the 12-hour, post-dose exposure period to ragweed pollen in the allergen challenge chamber.

Timeframe: N/A

Interventions:
Drug: GW685698X Aqueous Nasal Spray
Enrollment:
380
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Rhinitis, Allergic, Seasonal
Product
fluticasone furoate
Collaborators
Not applicable
Study date(s)
April 2005 to August 2005
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
  • Informed consent
  • Outpatient
  • Significant concomitant medical condition
  • Use of corticosteroids, allergy medications, or tobacco
Inclusion and exclusion criteria
Inclusion criteria:
  • Informed consent
  • Outpatient
  • Females must use appropriate contraception
  • Diagnosis of seasonal allergic rhinitis
  • Able to comply with study procedures
  • Literate
Exclusion criteria:
  • Significant concomitant medical condition
  • Use of corticosteroids, allergy medications, or tobacco
  • Clinically significant abnormal ECG
  • Laboratory abnormality
  • Positive pregnancy test
  • Allergy to any component of investigational product

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Woodstock, Georgia, United States, 30188
Status
Study Complete
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Study documents

Clinical study report
Available language(s): English
Download document(s)
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
2005-03-08

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

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