Chronic obstructive pulmonary disease Respiratory Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
188 patients with COPD, GOLD groups B-D, are recruited within 18 months. Based on the histological analysis of endobronchial biopsies taken by flexible bronchoscopy, patients are divided into two grou
Sponsors
University Hospital Basel
Eligibility
Sex/Gender
All
Age
40 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Age =40 years 2. COPD, as defined by the GOLD Guidelines and categorization in groups B-D 3. No acute exacerbation of COPD or any respiratory infection requiring medical attention or leading to a change in medication within the last 4 weeks 4. Unchanged respiratory medication regimen within the last 8 weeks 5. At least one exacerbation in the previous year 6. Current or ex-smokers with smoking history of = 10 pack-years 7. Willingness to participate in a longitudinal, cohort study 8. Capability to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Rapid fatal disease (with life expectancy less than 3 months) 2. Pulmonary condition other than COPD as the main respiratory disease 3. Current diagnosis of bronchial asthma 4. Severe immune-suppression including HIV, organ transplantation, ongoing chemotherapy for cancer 5. Pregnancy or breastfeeding 6. Chronic use of oral steroids (> 10 mg per day) for COPD 7. Intolerance or contraindication to aclidinium, formoterol or budesonide
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the differences in the mean decrease of post-bronchodilator FEV1 in milliliters measured using a spirometer at 12 months, between patients with low (=20%) and high (>20%) ASMC area and according to whether they received ICS or not | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediately after the run-in phase, at 3, 6, 9 and 12 months after randomization to compare changes in: 1. Modified Medical Research Council (MMRC) dyspnea scale 2. COPD assessment test (CAT) 3. Health-related quality of life, measured using SF-36, SGRQ 4. Pre and post bronchodilator body plethysmography/DLCO 5. Expiratory FeNO 6. Single and multiple-breath N2 wash-out 7. Forced impulse oscillometry 8. 6-minute walking distance (6MWD) 9. Movement patterns, measured using accelerometry 10. Therapy-related side effects (oral candidiasis, tachycardia, tremor, hoarseness, pneumonia) 11. Exacerbations rate 12. Serum biomarkers between patients with low (=20%) and high (>20%) ASMC area and according to whether they received ICS or not | — |
Countries
Switzerland
Contacts
Public ContactVivian Suarez Domenech
Outcome results
None listed