COPD
Conditions
Brief summary
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
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.
Interventions
OTHERNon-interventional
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.
Sponsors
Liverpool Heart and Chest Hospital NHS Foundation Trust
Chiesi UK
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
35 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with moderate to severe COPD (with and without concomitant asthma) 2. 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 3. Patients with at least one COPD exacerbation within the previous 12 months 4. Patients willing and able to sign informed consent for use of their pseudonymised clinical data within the present Non-Interventional Trial
Exclusion criteria
1. Patients hospitalised due to an exacerbation of their COPD within the last 4 weeks prior to enrolment 2. Participation within an interventional clinical trial within 30 days prior to enrolment into the present Non-Interventional Trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess change in health related quality of life in COPD patients prescribed Trimbow | 6 months | Change in total CAT score between baseline and after 6 months of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess adherence to COPD therapy | 6 months | changes in adherence scores (assessed by means of TAI questionnaire), |
| changes in relevant spirometry parameters | 6 months | between baseline, e.g. FEV1, FVC |
| incidence of clinical events | 6 months | e.g. exacerbations |
| Compare requirement of rescue medication and alteration of COPD therapy | 6 months | incidence of COPD medication changes and rescue medication use medication changes and rescue medication use |
Countries
United Kingdom
Outcome results
None listed