Non-interventional Study Related to Fixed LAMA/LABA/ICS Triple Therapy

Study Overview
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Brief Summary
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This is a prospective non-interventional trial to measure the health related quality of life of patients with chronic obstructive pulmonary disease (COPD) on a fixed LAMA/LABA/ICS triple therapy (Trimbow®) and characterisation of determinants of treatment adherence.

Detailed Description
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The primary goal of COPD therapy is the prevention of exacerbations and clinical deterioration. To achieve these goals, treatment adherence (i.e. taking medication as prescribed) is important. However, non-adherence (not taking medication as prescribed) is common in COPD and can be affected by lifestyle changes or use of multiple inhalers. The effects of Trimbow® on patients' health related quality of life, adherence and clinical outcomes have not been assessed in a UK real-world setting. This non-interventional trial aims to collect data from COPD patients under routine care over a 6 month period, for whom their doctors has decided to prescribe Trimbow® as per the authorised indication. We plan to investigate any changes in quality of life, as well as changes in lung function and the need for any additional therapy over 6 months. We also plan to investigate the adherence or reasons for non-adherence to Trimbow® as used in everyday routine.

Official Title
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A Prospective Non-interventional Trial on COPD Patients' Health Related Quality of Life Under a Fixed LAMA/LABA/ICS Triple Therapy and Characterization of Determinants of Treatment Adherence

Conditions
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COPD

Intervention / Treatment
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* Other: Non-interventional


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with moderate to severe COPD (with and without concomitant asthma) Physician decision to start therapy with Trimbow as per its current marketing authorisation; the treatment decision should be made independently from participation in this Non-Interventional Trial Patients with at least one COPD exacerbation within the previous 12 months Patients willing and able to sign informed consent for use of their pseudonymised clinical data within the present Non-Interventional Trial Exclusion Criteria: Patients hospitalised due to an exacerbation of their COPD within the last 4 weeks prior to enrolment Participation within an interventional clinical trial within 30 days prior to enrolment into the present Non-Interventional Trial

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 100 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 |
| --- | --- |
| COPD patients<br>Trimbow 87/5/9 pMDI for COPD prescribed according to licensed indication | Other: Non-interventional<br>* As this is a Non-interventional trial, only data obtained within the current routine management of COPD at outpatient respiratory centres or GP centres will be documented.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess change in health related quality of life in COPD patients prescribed Trimbow | Change in total CAT score between baseline and after 6 months of treatment. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess adherence to COPD therapy | changes in adherence scores (assessed by means of TAI questionnaire), | 6 months | 
| changes in relevant spirometry parameters | between baseline, e.g. FEV1, FVC | 6 months | 
| incidence of clinical events | e.g. exacerbations | 6 months | 
| Compare requirement of rescue medication and alteration of COPD therapy | incidence of COPD medication changes and rescue medication use medication changes and rescue medication use | 6 months |