A Study on the Control of Chronic Obstructive Pulmonary Disease (COPD) in Patients Taking the Combination of Tiotropium and Olodaterol Using the Respimat® Inhaler

Study Overview
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Brief Summary
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Open-label observational study which includes COPD patients that are receiving treatment with Spiolto® Respimat® for approximately 6 weeks, which is the average time between two medical consultations.

Official Title
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Changes in Clinical Control of COPD Patients Measured by the Clinical COPD Questionnaire During Therapy With Spiolto®Respimat® 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 based upon the investigator's decision requiring a new prescription of Spiolto Respimat® (combination of two long-acting bronchodilators) according to Spiolto® Respimat® SmPC, GOLD COPD Strategy Document 2018 (GOLD COPD groups B to D) and local COPD guidelines Exclusion Criteria: Patients with contraindications according to Spiolto® Respimat® SmPC Patients already on a LABA/LAMA combination (free and fixed dose) in the last 6 weeks before study entry Patients continuing LABA/ICS treatment should not be additionally treated with Spiolto® Respimat® in order to avoid a double dosing of long-acting beta-agonists Pregnancy and lactation 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 |
| --- | --- |
| subjects with COPD<br> | Drug: Spiolto® Respimat®<br>* Drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients With Therapeutic Success of Spiolto® Respimat® Treatment at Visit 2 | Therapeutic success of Spiolto® Respimat® treatment was defined as 0.4 point decrease in the Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire - Clinical COPD Questionnaire (CCQ) score from visit 1 to visit 2. Each of the 10 CCQ questions is scored by the patient on a 7-point scale between 0 (Never/Not limited at all) and 6 (Almost all the time/Totally limited or unable to do) at baseline (Visit 1) and at the end of the observation after approximately 6 weeks (Visit 2). The sum of the scores divided by 10 gives the CCQ score, which measures the health and functional status. A higher CCQ score is indicative of worse status. | At Visit 2 (6 weeks after baseline visit 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the Clinical COPD Questionnaire (CCQ) and the CCQ Symptom, Mental State and Functional State Domain Scores From Visit 1 (Baseline) to Visit 2 | The CCQ questionnaire contained 10 questions about symptoms, functional status and mental status. Each of the 10 CCQ questions was scored by the patient on a 7-point scale between 0 and 6 at baseline and at the end of observation after approximately 6 weeks. The sum of the scores divided by 10 gives the CCQ score which measures the health and functional status. A higher CCQ score is indicative of worse status. Change of the score was calculated as visit 2 minus visit 1. | At baseline visit 1 and 6 weeks thereafter at visit 2 | 
| Physician's Global Evaluation (PGE) Score at Visit 1(Baseline) | PGE score assessed the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent). | At visit 1 | 
| Physician's Global Evaluation (PGE) Score at Visit 2 | PGE score assessed the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent). | At visit 2 (6 weeks after baseline visit 1) | 
| Patient Overall Satisfaction With Spiolto® Respimat® Treatment at Visit 2 | Patient overall satisfaction with Spiolto® Respimat® treatment at visit 2 was reported. | At visit 2 | 
| Patient Satisfaction With Inhaling From the Respimat® Device at Visit 2 | Patient satisfaction with inhaling from the Respimat® device at visit 2 was reported | At visit 2 | 
| Patient Satisfaction With Handling of the Respimat® Inhalation Device at Visit 2 | Patient satisfaction with handling of the Respimat® inhalation device at visit 2 was reported. | At visit 2 | 
| Number of Participants Willing to Continue Treatment With Spiolto® Respimat® at Visit 2 | Number of participants willing to continue treatment with Spiolto® Respimat® at visit 2 was reported. | At visit 2 |