The treatment of chronic obstructive lung disease
- Conditions
- Chronic Obstructive Pulmonary Disease GOLD 0 is defined as patients with normal spirometry but with chronic symptoms such as cough and/or sputum production.Respiratory
- Registration Number
- ISRCTN16377955
- Lead Sponsor
- niversity Hospital of Basel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 158
Both groups:
1. Able to give informed consent as documented by signature
2. Age =40 years
3. FEV1/FVC =0.70
Intervention group: Current or past smokers
4. =10 pack years
5. At least one symptom from the following: (Cough, Phlegm, Shortness of breath)
Control group: Minimal smoking exposure
6. =1 pack year tobacco-smoking history
Both groups:
1. Pregnant or lactating women
2. Current increased (more than usual) respiratory symptoms
3. Concomitant respiratory disease (eg asthma, ILD) or clinically significant bronchiectasis
4. Unstable cardiovascular disease
5. Inability to follow the procedures of the study, e.g. due to language problems, dementia, etc.
6. Active pulmonary infection or prior pulmonary infection where antibiotic and/or steroid treatment was completed =4 weeks prior to enrolment
7. Enrolment in an interventional clinical trial within last 30 days
8. Severe immunosuppression including manifested AIDS, organ transplantation, ongoing chemotherapy for cancer or neutropenia (<500*10^9/L)
9. Chronic use of oral steroids (>10 mg per day)
Intervention group:
10. Severe allergy to milk proteins
11. Known allergy or intolerance to the study medication
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Sacin/Scond measured using The nitrogen multiple-breath washout (N2MBW) at baseline and 3 months after start of medication<br> 2. R5-19 measured using the force impulse oscillometry at baseline and 3 months after start of medication<br>
- Secondary Outcome Measures
Name Time Method