OTIVACTO Spain Non Interventional Study

Study Overview
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Brief Summary
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This is a self-controlled study design enrolling consented COPD patients who will be treated with Spiolto® Respimat® according to the approved SmPC. Patients will be enrolled consecutively and will be followed over an observational period of approx. 6 weeks.

Detailed Description
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Purpose: Study Design:

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

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Written informed consent prior to participation Female and male patients = or > 40 years of age Patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD) and requiring long-acting dual bronchodilation (Long-acting muscarinic antagonist (LAMA) + Long-acting beta2 agonist (LABA)) treatment according to approved Spiolto® Respimat® Summary of Product Characteristics (SmPC) and COPD Global Initiative for Chronic Obstructive Lung Disease (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 Long-acting beta2 agonist and inhalative corticosteroids (LABA-iCS) treatment should not be additionally treated with Spiolto® Respimat® in order to avoid a double dosing of long-acting beta2 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>QOL measurement of COPD patients taking Spiolto Respimat | |

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 subdomain 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 (visit 2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Mean Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2 | The change in Physical functioning questionnaire (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 mean for change from baseline values across all patients was calculated. The PF-10 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. | 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® at Visit 2 | A patient satisfaction questionnaire on how overall satisfied they were with the Spiolto® Respimat® treatment was also completed during visit 2, using a 7-point ordinal scale, from 1 (very unsatisfied) to 7 (very satisfied). | After approx. 6 weeks (visit 2) of treatment initiation | 
| Patient Satisfaction With Inhaling From the Respimat® Device | A patient satisfaction questionnaire on how satisfied they were by inhaling with the Respimat® device was also completed during visit 2, using a 7-point ordinal scale, from 1 (very unsatisfied) to 7 (very satisfied). | After approx. 6 weeks (visit 2) of treatment initiation | 
| Patient Satisfaction With Handling of the Respimat® Inhalation Device | A patient satisfaction questionnaire on how satisfied they were with handling of the Respimat® inhalation device was also completed during visit 2, using a 7-point ordinal scale, from 1 (very unsatisfied) to 7 (very satisfied). | After approx. 6 weeks (visit 2) of treatment initiation |