Effectiveness and Handling of Spiolto® Respimat ® in COPD Patients - Italy

Study Overview
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Brief Summary
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The purpose of the study is to measure changes in physical functioning in chronic obstructive pulmonary disease (COPD) patients being treated with Spiolto® Respimat® after approximately 6 weeks in routine clinical practice.

Detailed Description
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Purpose:

Official Title
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Effectiveness and Handling of Spiolto® Respimat ® in COPD Patients - Italy

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 therapeutic plan recommendation Exclusion criteria: Patients with contraindications according to Spiolto® Respimat® Summary of Product Characteristics (SmPC) Patients who have been treated with a LABA/LAMA combination (free and fixed dose) in the previous 6 months Patients continuing LABA-Inhalative Corticosteroids (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>consented COPD patients who will be treated with Spiolto® Respimat® according to the approved SmPC | Drug: Spiolto® Respimat®<br>* observations taken in a period of approximately 6 weeks<br>* Other names: INSPIOLTO, SPIOLTO, STIOLTO, VAHELVA, YANIMO;|

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 Approximately (Approx.) (Visit 2) | Therapeutic success defined as at least 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 ) and consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. Each question of the PF-10 can be answered with yes, limited a lot, yes, limited a little or no, not limited at all, with a score of 1, 2 or 3. The sum of the scores of the 10 questions results in a value between 10 (a patient answering all questions with yes, limited a lot) and 30 (a patient answering all questions with no, not limited at all). The final sum of the individual scores was standardized to a range of 0 to 100 using the following formula: [(sum of scale items - 10) * 100] / 20. Higher scores indicate better physical functioning. | after approximately 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Median Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2 | The 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) and then the median for change from baseline values across all subjects was calculated. | Baseline (visit 1) and after approx. week 6 (visit 2) | 
| Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 | The patient's general condition was evaluated by means of Physician's Global Evaluation (PGE) score. The PGE score is documented on a scale from 1 (poor) to 8 (excellent) at both visits. 1-2: poor; 3-4: satisfactory; 5-6: good; 7-8: excellent | Baseline (visit 1) and after approx.week 6 (visit 2) | 
| Patient Overall Satisfaction With Spiolto® Respimat® | Patients were asked how overall satisfied they were with the Spiolto® Respimat® treatment at Week 6 (approx.) (Visit 2). | After approx. 6 weeks of treatment initiation | 
| Patient Satisfaction With Inhaling From the Respimat® Device | Patients were asked how satisfied they were by inhaling with the Respimat® device at Week 6 (approx.) (Visit 2) | After approx. 6 weeks of treatment initiation | 
| Patient Satisfaction With Handling of the Respimat® Inhalation Device | Patients were asked how satisfied they were with handling of the Respimat® inhalation device at Week 6 (approx.) (Visit 2). | After approx. 6 weeks of treatment initiation |