Eosinophilic vs. Non-eosinophilic Asthma: Phenotyping and Gene Expression Profile
- Conditions
- J45Asthma
- Registration Number
- DRKS00004655
- Lead Sponsor
- Koordinationszentrum für klinische Studien
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
• Age: 18–65 years
• Recorded diagnosis (by a pulmonologist) of Asthma
• Signed informed consent
Exclusion Criteria
• Active smoking
• Ex-smokers that stopped smoking less than 12 months prior to inclusion
• COPD (according to GOLD guidelines; http://www.goldcopd.org)
• Treatment with very high doses of ICS (>800 µg/die budesonide equivalent) or systemic steroids at the time of inclusion
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the predictive value (at visit 1) of the VOC (volatile organic compound) profile analysis regarding sputum eosinophilia (= 3%), as assessed by AUC (area unter the curve) of the ROC (Receiver Operator characteristics) curve of the linear discriminant (electronic nose)
- Secondary Outcome Measures
Name Time Method - to analyse the predictive value of the VOC (volatile organic compound) profile analysis (at visit 1) for the clinical course (as measured by the change in ACQ-7) within three months