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Due to COVID pandemic not feasible to include patients for this study
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This non-interventional study aims to collect information on the patient's quality of life, as well as the quality of sleep when stepping up to a fixed triple maintenance therapy (Trimbow®) as per physicians' decision, independent from study participation, and to assess its effectiveness in daily life, in general practitioner setting.
This non-interventional study assesses the real-life effectiveness, with focus on patient's quality of life, of the fixed triple therapy Trimbow® after stepping up from a dual therapy in clinical practice at first line centres in patients with confirmed chronic obstructive pulmonary disease (COPD). Data will be collected on availability as per usual care at baseline, 3 and 6 months after inclusion.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trimbow | Combination Product | As this is a non-interventional study, all treatment decisions will be made at the discretion of the treating physician prior to enrolment in the study and during the entire period of the study. Treatment will be prescribed according to the product label in the summary of product characteristics. |
| Measure | Description | Time Frame |
|---|---|---|
| COPD symptoms | The patient's COPD symptoms at month 6 (visit 3), compared to baseline. This is measured by the COPD Assessment Test (CAT) questionnaire. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| COPD symptoms | The patient's COPD symptoms at month 3 (visit 2) | 3 months |
| Quality of sleep | The quality of sleep of the patients using the CASIS questionnaire at baseline, month 3 and 6 (visit 2 and 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Moderate/severe exacerbations | Number of moderate/severe exacerbations at baseline and at month 6 | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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The subject population will include adult patients aged 40 years or above diagnosed with COPD confirmed by spirometry (Tiffeneau index <0.7), who are stepping up from dual therapy (ICS/LABA or LABA/LAMA treatment at least 12 weeks prior to enrolment to the study) to a fixed triple maintenance therapy (Trimbow).
Approximately 800 patients are expected to be enrolled at 200 GP practices in Belgium.
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| Name | Affiliation | Role |
|---|---|---|
| Eric Marchand, MD, PhD | CHU Godinne UCL Namur | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General practitioners in the province of East Flanders | Ghent | East Flanders | 9000 | Belgium | ||
| General practitioners in the province of Flemish Brabant |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| 6 months |
| Treatment satisfaction | The patient's treatment satisfaction score using PGI-C at month 3 and 6 (visit 2 and 3) | 6 months |
| Rescue medication | Use of rescue medication at baseline and each follow-up visit (question on the past 7 days) | 6 months |
| Lung function parameters | Lung function parameters (FEV1, FVC) (if available) at baseline and each follow-up visit | 6 months |
| Leuven |
| Flemish Brabant |
| 3000 |
| Belgium |
| General practitioners in the province of Hainaut | Mons | Hainaut | 7000 | Belgium |
| General practitioners in the province of Limburg | Hasselt | Limburg | 3500 | Belgium |
| General practitioners in the province of Luxembourg | Arlon | Luxembourg | 6700 | Belgium |
| General practitioners in the province of Walloon Brabant | Wavre | Walloon Brabant | 1300 | Belgium |
| General practitioners in the province of West Flanders | Bruges | West Flanders | 8000 | Belgium |
| General practitioners in the province of Antwerp | Antwerp | 2000 | Belgium |
| General practitioners in the province of Liège | Liège | 4020 | Belgium |
| CHU-UCL-Namur | Namur | 5000 | Belgium |
| General practitioners in the province of Namur | Namur | 5000 | Belgium |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |