Clinical trial NCT04355546: Non-interventional Study Related to Fixed LAMA/LABA/ICS Triple Therapy
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Lead sponsor: Chiesi UK
Sponsor class: INDUSTRY
Collaborators: name: Liverpool Heart and Chest Hospital NHS Foundation Trust
First posted: 2020-04-21
Enrollment: 94
Sex: ALL
Minimum age (years): 35
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assess change in health related quality of life in COPD patients prescribed Trimbow
timeFrame: 6 months
Secondary outcomes:
measure: Assess adherence to COPD therapy
timeFrame: 6 months
measure: changes in relevant spirometry parameters
timeFrame: 6 months
measure: incidence of clinical events
timeFrame: 6 months
measure: Compare requirement of rescue medication and alteration of COPD therapy
timeFrame: 6 months
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Foundation Trust
Study officials:
References: