Studies of induced immune responses in smokers
Phase 1
- Conditions
- Airway inflammation in smokers with and without COPD and / or CBTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2010-023681-45-SE
- Lead Sponsor
- Verksamhetsområde Geriatrik, Lungmedicin och Allergologi vid Sahlgrenska Universitetssjukhuset
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
age 40-75,
smokers / non smokers
no regular medication (except birth control pills and antidepressants)
no chronic disease other than CB or COPD
informed consent
BMI / weight
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
Exclusion Criteria
asthma, atopy, eczema,
cardiovascular disorders
pregnancy,
regular medication
snuff, chewing tobacco
current participation in other studies
chronic disease other than COPD / CB
BMI / weight
diabetes
allergic reaction against ketobemidone, midazolam or lidocaine
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Analyse the immune response caused by local endotoxinexposure in the airways and blood of smokers with and without CB and / or COPD and to identify differences from healthy never-smokers<br>;Secondary Objective: To identify cellular and molecular targets for new drug treatment for chronic respiratory disease<br>;Primary end point(s): Cell content of the BAL fluid, changes in inflammtory cells and mediators in airways <br>;Timepoint(s) of evaluation of this end point: All samples will be analyzed immediately after bronchoscopy 1 and 2.<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Changes in the inflammatory cells and the mediators the blood.<br>;Timepoint(s) of evaluation of this end point: All samples will be analyzed immediately after bronchoscopy 1 and 2.<br>