Chronic obstructive pulmonary disease (COPD) Respiratory Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
COPD will be diagnosed according to the GOLD guidelines (forced expiratory volume in one second [FEV1]/forced vital capacity [FVC] ratio below 70% and an absolute reduction of FEV1 below 80% of the pr
Sponsors
University Hospital Basel (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age above 40 years, both men and women 2. Smoking history greater than or equal to 10 pack years 3. Moderate to very severe COPD (Global Initiative for chronic Obstructive Lung Disease [GOLD] II to IV) 4. Currently stable disease (at least 4 weeks after resolution of the last exacerbation) 5. Willingness to participate in a longitudinal, cohort study 6. Willingness of the family physician to have the patient included in a cohort study 7. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Rapid fatal disease 2. Pulmonary condition other than COPD as the main respiratory disease, e.g. bronchiectasis, asthma or pulmonary fibrosis 3. Immunosuppression including human immunodeficiency virus (HIV), organ transplantation or chronic steroid use (more than 10 mg prednisolone-equivalent per day) 4. Patients unable and unwilling to give written informed consent 5. Musculoskeletal process preventing ambulation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical end-points include the following (duration of follow-up: two years): 1. Number of exacerbations, including exacerbations requiring hospitalisation and exacerbations managed by the primary care physicians 2. Number of deaths of any cause 3. Number of respiratory-related deaths 4. Time to next exacerbation, time to next exacerbation requiring hospitalisation and time to death 5. Duration of hospitalisation 6. Admission and length of stay in intensive care unit 7. Need for intubation or non-invasive ventilation 8. Need for oral steroids and antibiotics 9. Lung function and 6-minute walk test changes | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life assessed by Saint Georges Respiratory Questionnaire and the 36-item Short Form Health Survey (SF-36) at every scheduled visits during the follow-up phase (every 6 months) and 4 weeks after an exacerbation 2. Dyspnea and respiratory symptoms as assessed by the Modified Medical Research Council (MMRC) scale and Lower Respiratory Tract Illness - Visual Analogue Scale (LRTI-VAS) at every scheduled visits during the follow-up phase (every 6 months) and 4 weeks after an exacerbation Added 27/10/2010: 3. Measurement of daily physicial activity as assessed by a triaxial accelerometer at stable phase of the disease and exacerbation | — |
Countries
Belgium, Germany, Greece, Italy, Netherlands, Serbia, Spain, Switzerland
Outcome results
None listed