Changes in Health and Functional Status in Patients With Chronic Obstructive Pulmonary Disease During Therapy With Spiolto® Respimat® (AERIAL®)

Study Overview
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Brief Summary
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The objective of this NIS is to measure changes in health status including functional status using CCQ scores in COPD patients receiving treatment with Spiolto® Respimat® according to label after approximately 6 weeks in routine clinical practice.

Detailed Description
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The objective of this NIS is to measure changes in health status including functional status using CCQ scores in COPD patients receiving treatment with Spiolto® Respimat® according to label after approximately 6 weeks in routine clinical practice. In visit 1, patient data on demographics, smoking status, medical history, breathlessness, general condition, health and functional status and adverse drug reactions will be collected. In visit 2, after approximately 6 weeks, data on smoking status, concomitant diseases and medication, general condition, health and functional status and adverse drug reactions will be collected; additionally data on patient satisfaction, continuation or discontinuation of treatment and the reason in case of discontinuation.

Official Title
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AERIAL®: Changes in Health and Functional Status in Patients With COPD During Therapy With Spiolto® Respimat®

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: Patients can be included if all of the following criteria are met: Written informed consent prior to participation Female and male patients ≥40 years of age Patients diagnosed with COPD and requiring a combination of two long-acting bronchodilators (LAMA + LABA) according to approved SmPC and GOLD COPD guideline recommendation 2017 (GOLD COPD groups B to D) Treatment with Spiolto® Respimat® acc. to SmPC at the discretion of the physician. 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 |
| --- | --- |
| patients treated with Spiolto® Respimat®<br>Patients with COPD | Drug: Spiolto® Respimat®<br>* 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 |
| --- | --- | --- |
| Therapeutic Success | The primary endpoint of the study was therapeutic success at 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. A decrease of 0.4 points is considered to be the minimal clinically important difference (MCID) for both CCQ score and CCQ-4. | Final visit at the end of the study, approximately 6 weeks after start of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Changes in CCQ and CCQ-4 From Visit 1 to Visit 2 | Absolute changes in total CCQ score and CCQ-4 score from baseline visit at the start of the study to final visit at the end of study. The CCQ questionnaire contained 10 questions about symptoms, functional status and mental status. 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. A change of 0.4 points is was considered to be the minimal clinically important difference (MCID) for both CCQ score and CCQ-4. | Final visit at the end of the study, approximately 6 weeks after start of study | 
| General Condition of the Patient | General condition of the patient, evaluated by the physician (Physician's global Evaluation score) at visit 1 and visit 2. The treating physician used the Physician's Global Evaluation (PGE) to evaluate the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent). The modified Medical Research Council (mMRC) scale was used to assess the breathlessness state of the patient before the treatment. | Baseline visit (Visit 1) at the start of the study and final visit at the end of the study (visit 2), approximately 6 weeks after visit 1 | 
| Patient Satisfaction With Spiolto® Respimat® at Visit 2 | A patient satisfaction survey was performed at visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied. The 7-item satisfaction scale is a self-designed Boehringer-Ingelheim scale, without a public source or validation status. | 6 weeks | 
| Number of Participants Willing to Continue Treatment With Spiolto® Respimat® at Visit 2 | To assess the willingness to continue treatment with Spiolto® Respimat® at visit 2 patients were asked a yes/no question if they would continue the treatment. | 6 weeks |