NCT00331058TerminatedPhase 1
A Study To Validate Key Therapeutic Targets and Characterise Their Response to Corticosteroids in Multiple Asthma Phenotypes
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- GlaxoSmithKline
- Enrollment
- 58
- Locations
- 3
- Primary Endpoint
- evaluate changes in target expression in response to a 2 week course of corticosteroids across the 4 asthma phenotypes
Study Overview
Brief Summary
The primary goal of this study is to compare the expression of key GSK drug targets across the 4 asthma phenotypes and healthy subjects and secondarily to evaluate changes in target expression in response to a 2-week course of corticosteroids across the 4 asthma phenotypes. Each asthmatic subject in this study will undergo two bronchoscopies. Each healthy subject will undergo one bronchoscopy.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
evaluate changes in target expression in response to a 2 week course of corticosteroids across the 4 asthma phenotypes
Time Frame: visits 3 through to and including visit 6
compare key drug targets across 4 asthma phenotypes and healthy subjects
Time Frame: visits 3 through to and including visit 6
Secondary Outcomes
- Cytospins(visits 3 through to and including visit 6)
- Histopathology on bronchial biopsies(visits 3 through to and including visit 6)
- target expression in the blood(visits 3 through to and including visit 6)
- inflammatory markers(visits 3 through to and including visit 6)
- Quality of life (QoL) and symptom scores(visits 3 through to and including visit 6)
- activation state of a signalling pathway(visits 3 through to and including visit 6)
- target protein expression(visits 3 through to and including visit 6)
- Measures of pulmonary inflammation(visits 3 through to and including visit 6)
- Assessments of lung structure(visits 3 through to and including visit 6)
- lung function(visits 3 through to and including visit 6)
- Changes in medication(visits 3 through to and including visit 6)
- new targets and biomarkers(visits 3 through to and including visit 6)
- Radiological Parameters(visits 3 through to and including visit 6)
- Pharmacogenomics from blood samples(visits 3 through to and including visit 6)
- Whole Blood TaqMan and/or transcriptomic analysis(visits 3 through to and including visit 6)
- TaqMan and/or Differential Gene Expression and Proteomics(visits 3 through to and including visit 6)
Investigators
Study Sites (3)
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