Assessment Of Disease Pathology And Key Therapeutic Targets In Severe Asthma
- Registration Number
- NCT00327197
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
To evaluate and compare the expression and change in expression of key severe asthma targets at baseline in mile to moderate asthmatics vs. severe asthmatic subjects.
To evaluate and compare the airway pathology at baseline and changes in airway pathology in relation to asthma severity.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 47
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Severe asthma group Prednisolone Subjects with severe persistent asthma. They will be on either: high inhaled corticosteroid (CS \>=1000 microgram fluticasone daily or equivalent) or on high dose inhaled CS plus oral CS (no more than 20 milligrams predisolone a day). The subjects should have at least one ( if on oral steroids) or two (if only on inhaled steroids) of the following: 1) FEV1\<80% and FEV1/FVC ratio \<70% 2) more than 25% variability in peak expiratory flow 3) daily symptoms ± nocturnal symptoms 4) severe exacerbations of \>= twice a year in at least one of the last two years. Mild to moderate persistent asthmatic group Bronchoscopy Subjects with mild to moderate persistent asthma on low to moderate dose of inhaled corticosteroid (200-500 microgram fluticasone propionate daily or equivalent), an FEV1 \>= 80% predicted (post-bronchodilator), and less than 20% variability in peak expiratory flow. Intermittent mild steroid-naïve asthmatic group Bronchoscopy Asymptomatic subjects receiving only beta-agonist inhaler with predicted FEV1 \>=80% and normal peak expiratory flow between attacks will be included. Healthy subjects group Bronchoscopy Non-asthmatic and non-smokers with FEV1 \> 85% predicted, on no regular medication. Severe asthma group Bronchoscopy Subjects with severe persistent asthma. They will be on either: high inhaled corticosteroid (CS \>=1000 microgram fluticasone daily or equivalent) or on high dose inhaled CS plus oral CS (no more than 20 milligrams predisolone a day). The subjects should have at least one ( if on oral steroids) or two (if only on inhaled steroids) of the following: 1) FEV1\<80% and FEV1/FVC ratio \<70% 2) more than 25% variability in peak expiratory flow 3) daily symptoms ± nocturnal symptoms 4) severe exacerbations of \>= twice a year in at least one of the last two years. Mild to moderate persistent asthmatic group Prednisolone Subjects with mild to moderate persistent asthma on low to moderate dose of inhaled corticosteroid (200-500 microgram fluticasone propionate daily or equivalent), an FEV1 \>= 80% predicted (post-bronchodilator), and less than 20% variability in peak expiratory flow. Intermittent mild steroid-naïve asthmatic group Prednisolone Asymptomatic subjects receiving only beta-agonist inhaler with predicted FEV1 \>=80% and normal peak expiratory flow between attacks will be included.
- Primary Outcome Measures
Name Time Method Airway pathology endpoints Target Validation endpoints Biomarker endpoints Clinical endpoints Through 2 weeks of Prednisolone dosing biomarkers, vital signs, ECG
- Secondary Outcome Measures
Name Time Method Expression of airway and systemic biomarkers. Relationship between changes in target expression and clinical measures of disease activity. Relationship between steady state plasma exposure of prednisolone and pharmacodynamic biomarkers. Through 2 weeks of prednisolone dosing. biomarkers
Trial Locations
- Locations (1)
GSK Investigational Site
🇬🇧Leicester, Leicestershire, United Kingdom