Last updated: 11/04/2018 06:36:37
Exploration Of Key Targets And Biomarkers Involved In An Allergic Response In Subjects With Allergic Rhinitis (Hay Fever)
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Study to Validate Key Therapeutic Targets and Biomarkers during Allergen Exposure in Subjects with Allergic Rhinitis
Trial description: This study is aimed at validating key therapeutic targets and biomarkers associated with allergic rhinitis. The therapeutic target expression will be investigated after a 7 day course of corticosteroid treatment followed by allergen challenge.
Primary purpose:
Diagnostic
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: Fluticasone Propionate
Enrollment:
48
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Allergic Rhinitis
Product
fluticasone propionate
Collaborators
Not applicable
Study date(s)
April 2005 to May 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 65 Years
Accepts healthy volunteers
no
- No signs or symptoms of rhinitis outside of the relevant airborne allergen season.
- History or current evidence of an upper or lower respiratory infection or symptoms (including common cold) within 2 weeks of baseline assessments.
- Symptoms of rhinitis at inclusion indicated by total VAS score of >40 for the
Inclusion and exclusion criteria
Inclusion criteria:
- No signs or symptoms of rhinitis outside of the relevant airborne allergen season.
Exclusion criteria:
- History or current evidence of an upper or lower respiratory infection or symptoms (including common cold) within 2 weeks of baseline assessments.
- Symptoms of rhinitis at inclusion indicated by total VAS score of >40 for the combined symptoms scores for blockage, rhinorrhoea, sneezing, itching) or a single symptom with a VAS score >20.
- Subjects not showing a nasal response to allergen concentration =< 10,000 BU/ml.
- Subjects with positive skin prick test for Dust House Mite.
Trial location(s)
Location
GSK Investigational Site
London, London, United Kingdom, WC1X 8DA
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
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
2007-06-05
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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