An observational study to obtain normal values of inflammatory variables in induced sputum, exhaled breath, and bronchial biopsies from healthy smoking and non-smoking individuals
- Conditions
- AsthmaCOPDemphysema10006436
- Registration Number
- NL-OMON33652
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
1. Doctor*s diagnosis of normal pulmonary health
2. Post bronchodilator FEV1/FVC >70%
3. PC20 methacholine >12 mg/ml
4. Reversibility of FEV1% predicted <10%
1. Persons who used inhaled or oral corticosteroids during >5 years, or
within the last 5 years.
2. FEV1 <1.2 L,
3. A subject is not eligible to enter and participate if he does not agree
that we inform his general practicioner about participation in the study and also
about any unexpected finding during the study.
4. Upper respiratory tract infection (e.g. colds), within 2 months.
5. Pregnancy, or the possibility of being pregnant (i.e. women who do not use adequate anticonception as judged by the investigator).
6. Malignancy within the past 5 years (except for squamous or basal cell carcinoma
of the skin that has been treated with no evidence of recurrence).
7. Signs or symptoms of any other concomitant disease that, in the eyes of the
investigator, can interfere with the study results.
8. Known recent substance abuse (drug or alcohol).
9. Claustrophobia
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Parameters for airway inflammation and remodeling in bronchial biopsies. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Parameters for airway inflammation in sputum and blood.<br /><br>HRCT scan<br /><br>symptoms<br /><br>Lung function </p><br>