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
Conditions
Interventions
Intervention group: Demographic and medical history data will be collected. At baseline, participants will undergo lung function testing including body plethysmography and diffusion capacity, FeNO, FO
Sponsors
University Hospital of Basel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 (10 mg per day) Intervention group: 10. Severe allergy to milk proteins 11. Known allergy or intolerance to the study medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Sacin/Scond measured using The nitrogen multiple-breath washout (N2MBW) at baseline and 3 months after start of medication 2. R5-19 measured using the force impulse oscillometry at baseline and 3 months after start of medication | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Lung function (LCI, FEV1, FOT, etc) measured using body plethysmography, at baseline and 3 months after start of medication 2. Walking distance measured using 6MWT, at baseline and 3 months after start of medication 3. Bacteriology measured using in sputum Analyse, at baseline and 3 months after start of medication 4. Rheology measured using body plethysmography and 3 months after start of medication 5. Blood parameters measured using blood samples, at baseline and 3 months after start of medication 6. Radiographic imagery measured using low-dose CT-scan, at baseline and 3 months after start of medication 7. Questionnaire: Severity of symptoms measured using the COPD Assessment Test (CAT) at baseline and 3 months after start of medication. Severity of symptoms measured using the modified Medical Research Council Dyspnea Scale – mMRC, at baseline and 3 months after start of medication. Impact on overall health, daily life, and perceived well-being measured using St. Georges respiratory questionnaire, at baseline and 3 months after start of medication. The Health concepts measured using the Short Form Survey (SF-36). The health-related quality of life measured using EQ-5D. 8. Basic characteristics measured using patient interviews. | — |
Countries
Switzerland
Outcome results
None listed