Prospective, multi-centre, non-interventional study to collect findings about the effects of LABA/LAMA (Long Acting Beta2-Agonists / Long Acting Muscarinic Antagonists) combination preparations on COPD (Chronic obstructive pulmonary disease) symptoms and quality of life under real conditions and to find out what types of patients are selected for this therapy by physicians.
Retrospective aspect of documentation: For patients who have already been changed over to a fixed-dose combination, lung function parameters and CAT (COPD Assessment Test™) score from the time prior to the changeover will be documented.
Study Type
OBSERVATIONAL
Enrollment
3,732
Lung function
Assessment of FEV1 (Forced Expiratory Volume), FVC (Forced Vital Capacity)
Time frame: First visit (baseline)
Number of patients with concomitant diseases classified by diagnostic subgroups
Time frame: First visit (baseline)
Number of patients receiving concomitant COPD (Chronic obstructive pulmonary disease) medication classified by therapeutic subgroups
Time frame: First visit (baseline)
Number of patients with exacerbations within the previous 24 months
History of previous exacerbations that will be collected at first observational visit.
Time frame: First visit (baseline)
Change in well-being and quality of life
CAT (COPD Assessment Test™) questionnaire will be completed at each visit, approximately every 3 months.
Time frame: First visit (baseline) to end of observational period at 12 months
Effect on the severity of the shortness of breath
mMRC (modified Medical Research Council Dyspnea Scale) questionnaire will be completed at each visit, approximately every 3 months.
Time frame: First visit (baseline) to end of observational period at 12 months
Change in the night-time and early-morning COPD symptoms
NiSCI/EMSCI (Night-time symptoms of COPD Instrument / Early-morning symptoms of COPD instrument) questionnaire will be completed at each visit, approximately every 3 months.
Time frame: First visit (baseline) to end of observational period at 12 months
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Research Site
Aachen, D6570r00001, Germany
Research Site
Aldenhofen, D6570r00001, Germany
Research Site
Aldenhoven, D6570r00001, Germany
Research Site
Alzey, D6570r00001, Germany
Research Site
Ansbach, D6570r00001, Germany
Research Site
Apolda, D6570r00001, Germany
Research Site
Aschau, D6570r00001, Germany
Research Site
Auerbach, D6570r00001, Germany
Research Site
Augsburg, D6570r00001, Germany
Research Site
Bad Fallingbostel, D6570r00001, Germany
...and 170 more locations
Lung function
Assessment of FEV1, FVC at each visit, approximately every 3 months.
Time frame: First visit (baseline) to end of observational period at 12 months
Number of exacerbations by grade
Number of exacerbations will be collected at each visit, approximately every 3 months
Time frame: First visit (baseline) to end of observational period at 12 months
Adverse events
Adverse events will be collected at each visit, approximately every 3 months.
Time frame: First visit (baseline) to end of observational period at 12 months
Handling of inhaler
Questionnaire regarding handling of inhaler by patient
Time frame: At 12 months