Assessment of Physical Functioning and Handling of Spiolto® Respimat® in Patients With Chronic Obstructive Pulmonary Disease (COPD) Requiring Long-acting Dual Bronchodilation in Routine Clinical Practice

Study Overview
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Brief Summary
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The primary objective of the study is to measure changes in physical functioning - serving as a surrogate for physical activity and exercise capacity - in COPD patients being treated with Spiolto® Respimat® after approximately 6 weeks. A secondary objective is to evaluate the patient¿s general condition (physician¿s evaluation) at visit 1 (baseline visit at the start of the study) and at visit 2 (final visit at the end of the study, approx. 6 weeks after visit 1), as well as patient satisfaction with Spiolto® Respimat® at visit 2.

Official Title
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Assessment of Physical Functioning and Handling of Spiolto® Respimat® in Patients With Chronic Obstructive Pulmonary Disease (COPD) Requiring Long-acting Dual Bronchodilation in Routine Clinical Practice

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: Spiolto Respimat


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Written informed consent prior to participation Female and male patients = 40 years of age Patients diagnosed with COPD and requiring long-acting dual bronchodilation (LAMA + LABA) treatment according to approved Spiolto® Respimat® SmPC and COPD GOLD guideline recommendation Exclusion criteria: Patients with contraindications according to Spiolto® Respimat® SmPC Patients who have been treated with a LABA/LAMA combination (free and fixed dose) in the previous 6 months Patients continuing LABA- Inhalative Corticosteroides (iCS)treatment should not be additionally treated with Spiolto® Respimat® in order to avoid a double dosing of long-acting beta-agonists Patients for whom further follow-up is not possible at the enrolling site during the planned study period of approx. 6 weeks Pregnancy and lactation Patients currently listed for lung transplantation Current participation in any clinical trial or any other non-interventional study of a drug or device

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 |
| --- | --- |
| Spiolto Respimat<br>COPD patients requiring a fixed combination therapy of two long-acting bronchodilators (LAMA + LABA) according to approved Summary of Product Characteristics (SmPC) and Global Initiative for Chronic Obstructive Lung Disease (GOLD)guidelines | Drug: Spiolto Respimat<br>* Tiotropium bromide + Olodaterol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With Therapeutic Success at Week 6 (Approx.) (Visit 2). | Therapeutic success defined as a minimum 10-point increase of Physical functioning questionnaire (PF-10 ) score after approximately 6 weeks of Spiolto® Respimat® treatment The PF-10 used for assessing the primary outcome physical functioning is a sub-domain of the validated Short Form 36 (SF-36) quality of life questionnaire and consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. The total score ranges from 0 to 100. A higher score indicates a better physical functioning. | after approximately 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the PF-10 Score From Visit 1 to Visit 2 | Change in PF-10 score was determined by taking into account the individual change of each patient between Baseline (Visit 1) and Week 6 (approx.) (Visit 2). | baseline and approx. week 6 | 
| General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. | Physician's Global Evaluation (PGE) score documented by physicians at visit 1 (baseline) and at visit 2 (approx. 6 weeks later). the PGE score documented from 1 to 8. The highest value (=8) representing an excellent general condition | Baseline (Visit 1) and Week 6 (approx.) (Visit 2) | 
| Patient Overall Satisfaction With Spiolto® Respimat® at Week 6 (Approx.) (Visit 2). | At Week 6 (approx.) (Visit 2) patients were asked how overall satisfied they were with the Spiolto® Respimat® treatment. | Week 6 (approx.) (Visit 2) | 
| Patient Satisfaction With Inhaling From the Respimat® Device at Week 6 (Approx.) (Visit 2). | At Week 6 (approx.) (Visit 2) patients were asked how satisfied they were by inhaling with the Respimat® device. | Week 6 (approx.) (Visit 2) | 
| Patient Satisfaction With Handling of the Respimat® Inhalation Device at Week 6 (Approx.) (Visit 2). | At Week 6 (approx.) (Visit 2) patients were asked how satisfied they were with handling of the Respimat® inhalation device | Week 6 (approx.) (Visit 2) |