Study in Patients' With Persistent Asthma and Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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The study is to evaluate the percentage of patients with asthma or COPD achieving disease control

Detailed Description
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There are no treatment groups or interventions to which the patients can be randomly assigned. Data will be collected in a routine setting on a single occasion during an otherwise normal visit at the physician's office or clinic. Participating physicians will not perform any medical procedures that are outside of their normal daily clinical practice. All treatment decisions are at the sole discretion of the participating physicians and reflect their current standard of care

Official Title
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A Phase IV Real-World Multi-Country Observational Study on Patients' Disease Control and Self-Reported Outcomes During Fixed Dose Combination Inhaler Treatment for Persistent Asthma and COPD

Conditions
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Asthma, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: Marketed antagonists


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient ≥ 18 years of age who has been diagnosed with persistent asthma or patient ≥ 40 years of age and/or (ex)-smoker with more than 10 pack years of smoking who has been diagnosed with COPD Treatment with a stable dose (no change in dose or change by less than 50% in the last 3 months) of a Inhaled corticosteroid (ICS), Long-acting beta2-agonists (LABA), Fixed dose combination (FDC) administered twice daily by Dry powder inhaler (DPI) for 3 months prior to enrollment in accordance with its approved indication Patient is willing and able to provide written informed consent; Patient agrees to participate in the study and to disclose any medical events to the treating physician; Patient is able to complete the questionnaires. Exclusion Criteria: • Current enrolment or planned enrolment in an interventional study (patients are allowed to participate in other observational or case-control studies).

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Patient Participants<br>Patients are confirmed to have either Persistent Asthma or COPD | Drug: Marketed antagonists<br>* Medication for each patient is determined by the physician based on the patient's individual clinical profile and in accordance with the approved indication and label of the prescribed drug<br>* Other names: as prescribed;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients whose respiratory disease is well controlled | Questionnaires capture descriptive, qualitative responses | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction Score | A 10-point scale (where 1 = not at all satisfied and 10 = extremely satisfied) is used to assess the patients' satisfaction | 1 Day | 
| Proportion of patients who comply with treatment according to Morisky Medication Adherence Scale (MMAS-8) | The 8-item MMAS-8 is a self-reported instrument to measure medication adherence | 1 Day | 
| Most Important Inhaler Features (MIIF) questionnaire | MIIF is a 10-point rating scale (where 1 = not at all easy and 10 = extremely easy) for the 5 most important features | 1 Day | 
| Percentage of Participants with Adverse Events |  | 3 years |