DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Non-interventional Study for Documentation of the Therapeutic Efficacy, Use and Tolerance of the Fixed-Dose Combinations (FDC) Duaklir® Genuair® (Aclidinium/Formoterol), Ultibro® Breezhaler® (Glycopyrronium/Indacaterol) and Anoro® (Umeclidinium/Vilanterol) in the Treatment of COPD Under Real Conditions in the Practices of Pneumologists, Internists, and General Practitioners

Conditions
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Chronic Obstructive Pulmonary Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female/male of at least 40 years of age Patient diagnosed with COPD Patient was changed over within the last 3 months to a fixed-dose combination (FDC) (Aclidinium/Formeterol, Glycopyrronium/Indacaterol or Umeclidinium/Vilanterol), or there is already the intent to change the patient over to a fixed-dose combination (Aclidinium/Formeterol, Glycopyrronium/Indacaterol or Umeclidinium/Vilanterol). Lung function parameters and CAT score from the time prior to the changeover to an FDC are on record (within the last 6 months in the case of patients who have already been changed over) or are determined at the 1st visit (in the case of patients who have not yet been changed over but for whom such a changeover is intended). Signed declaration of consent Exclusion Criteria: The prescribing information for the fixed-dose combinations (Duaklir® Genuair®, Ulibtro® Breezhaler® or Anoro®) list contraindications for the patient. Patient is pregnant, plans to become pregnant, or is nursing during the therapy period. Patient suffers from hypersensitivity to one of the active ingredients of the fixed-dose combinations. Patient is participating in a clinical trial.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients on Duaklir® Genuair®<br>Patients on fixed-dose combination Duaklir® Genuair® (Aclidinium/Formoterol) | |
| Patients on Ultibro® Breezhaler®<br>Patients on fixed-dose combination Ultibro® Breezhaler® (Glycopyrronium/Indacaterol) | |
| Patients on Anoro®<br>Patients on fixed-dose combination Anoro® (Umeclidinium/Vilanterol) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung function | Assessment of FEV1 (Forced Expiratory Volume), FVC (Forced Vital Capacity) | First visit (baseline) | 
| Number of patients with concomitant diseases classified by diagnostic subgroups |  | First visit (baseline) | 
| Number of patients receiving concomitant COPD (Chronic obstructive pulmonary disease) medication classified by therapeutic subgroups |  | 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. | First visit (baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in well-being and quality of life | CAT (COPD Assessment Test™) questionnaire will be completed at each visit, approximately every 3 months. | 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. | 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. | First visit (baseline) to end of observational period at 12 months | 
| Lung function | Assessment of FEV1, FVC at each visit, approximately every 3 months. | 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 | 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. | First visit (baseline) to end of observational period at 12 months | 
| Handling of inhaler | Questionnaire regarding handling of inhaler by patient | At 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Obstructive Pulmonary Disease, Fixed-dose Combination, LAMA/LABA (Long Acting Beta2-Agonists / Long Acting Muscarinic Antagonists), Inhaler, Aclidinium/Formoterol, Glycopyrronium/Indacaterol, Umeclidinium/Vilanterol