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| Name | Class |
|---|---|
| Liverpool Heart and Chest Hospital NHS Foundation Trust | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COPD patients | Trimbow 87/5/9 pMDI for COPD prescribed according to licensed indication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-interventional | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will only be included in the Non-Interventional Trial if Trimbow® has been prescribed in line with its current marketing authorisation and the guidance specified in the summary of product characteristics (SmPC).
Physicians are urged to offer enrolment to all of their eligible patients consecutively as they present for their routine visit, and not select patients from their patient database.
Eligible patients may only be included in the NIT after providing written (witnessed, where required by law or regulation), IEC-approved informed consent, or, if incapable of doing so, after such consent has been provided by a legally acceptable representative of the patient.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liverpool Heart and Chest Foundation Trust | Liverpool | L14 3PE | United Kingdom |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| 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 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |