Spiolto® Respimat® (Tiotropium/Olodaterol) Versus Triple Combination Therapy in Everyday Clinical Treatment Practice for Chronic Obstructive Pulmonary Disease (EVELUT®)

Study Overview
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Brief Summary
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Open-label comparative multicentric cohort study in COPD patients with LABA/ICS, switched to either tiotropium/olodaterol and observed for 12 weeks approximately.

Detailed Description
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COPD patients on LABA/ICS maintenance therapy with dyspnea (mMRC ≥ 1) and other symptoms (CATTM ≥ 10), who are switched to either Spiolto® Respimat® in the new reusable inhaler or any triple therapy (LAMA + LABA + ICS) as an open or fixed combination according to approved SmPCs at baseline at the discretion of their attending physician.

Official Title
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EVELUT®: Assessment of Dyspnea and Other Symptoms as Patient Reported Outcomes (PRO) in Patients With Chronic Obstructive Pulmonary Disease (COPD), Symptomatic on LABA/ICS Maintenance Therapy (Now) Treated With Spiolto® Respimat® (Tiotropium/Olodaterol) in Comparison to Open or Fixed Triple Combination Treatment in Routine Clinical Practice

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: Long-acting muscarinic antagonist+ Long-acting beta2 adrenoceptor agonist
* Drug: Triple combination of Free or fixed Long-acting muscarinic antagonist+ Long-acting beta2 adrenoceptor agonist + inhalative corticosteroids


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients can be included if all of the following criteria are met: Diagnosis of COPD Symptomatic (with regard to dyspnea (mMRC Dyspnea score ≥1) AND with regard to symptoms (CAT Score ≥10) at the same time) Patients on LABA/ICS maintenance therapy who are switched to Spiolto® Respimat® in the new reusable inhaler or a free/fixed triple combination of LABA + LAMA + ICS at Visit 1 at the discretion of the treating physician. Adults who are contractually capable and mentally able to understand and follow the instructions of the study personnel Male or female Patients aged ≥40 years of age Written informed consent prior to study participation The patient is willing and able to follow the procedures outlined in the protocol Exclusion Criteria: Patients with contraindications acc. to SmPC Patients not on LABA/ICS maintenance treatment at visit 1, e.g., mono or dual bronchodilation only, ICS only, or a triple combination of LAMA + LABA + ICS (either as a fixed combination product or as separate components) Lack of informed consent Pregnant and/or lactating females Acute exacerbation of COPD (within 4 weeks prior to Visit 1) Frequently exacerbating patients, i. e. patients with ≥2 moderate exacerbations within the last 12 months or ≥1 exacerbation leading to hospitalization within the last 12 months Acute respiratory failure (pH <7,35 and/ or respiratory rate >30/min within 3 months prior to Visit 1) History or current diagnosis of asthma History or current diagnosis of asthma-COPD overlap History or current diagnosis of allergic rhinitis within the last 5 years History or current diagnosis of lung cancer within the last 5 years Participation in a parallel interventional clinical trial mild exacerbation: additional use of short-acting bronchodilators and treated by the patient without consulting a physician moderate exacerbation: treatment includes medical prescription of a systemic corticosteroid and/or antibiotic severe exacerbation: exacerbation leading to hospitalization

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 |
| --- | --- |
| Subject with Chronic Obstructive pulmonary disease<br> | Drug: Long-acting muscarinic antagonist+ Long-acting beta2 adrenoceptor agonist<br>* LAMA+LABA<br>* Other names: Spiolto® Respimat®;Drug: Triple combination of Free or fixed Long-acting muscarinic antagonist+ Long-acting beta2 adrenoceptor agonist + inhalative corticosteroids<br>* (LAMA+LABA+ Inhalative Corticosteroids (ICS)<br>* Other names: LAMA+LABA+ Inhalative Corticosteroids (ICS);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between modified Medical Research Council score at baseline (visit 1) and mMRC score after end of observation | The modified Medical Research Council (mMRC) scale is a 5-point (0-4) scale based on the severity of dyspnoea | 12 weeks | 
| Difference between CAT score at baseline (visit 1) and CATTM score after end after end of observation | The COPD Assessment Test (CAT TM) consists of eight items -cough, phlegm, chest tightness, breathlessness when going up hills/stairs, activity limitations at home, confidence leaving home, sleep and energy. CAT TM is a trademark. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient's general condition according to the Physician's Global Evaluation (PGE) score at baseline and end of the observation period | PGE evaluates the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent) before and approx. 12 weeks after treatment initiation | upto 12 weeks | 
| patient satisfaction with inhaler and therapy at end of observation period according to a seven-point ordinal scale (ranging from very dissatisfied to very satisfied as documented in non-interventional BI studies | A7-item satisfaction scale with divisions from very dissatisfied to very satisfied to measure patient satisfaction with inhaler use, is a Likert-scale without validation status for the intended use | upto 12 weeks | 
| proportion of responders with mMRC ≥1 and the proportion of responders with CAT ≥2 |  | upto 12 weeks |