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

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

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.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Other: Non-interventional

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.

• Study Type: Observational
• Enrollment (Actual): 94

Contacts and Locations

Study Locations

• United Kingdom
  • Liverpool, United Kingdom, L14 3PE
    • Liverpool Heart and Chest Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COPD patients; Trimbow 87/5/9 pMDI for COPD prescribed according to licensed indication	Other: Non-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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chiesi UK
• Collaborators: Liverpool Heart and Chest Hospital NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2020
• Primary Completion (Actual): June 9, 2022
• Study Completion (Actual): June 9, 2022

Study Registration Dates

• First Submitted: April 20, 2020
• First Submitted That Met QC Criteria: April 20, 2020
• First Posted (Actual): April 21, 2020

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: NIS 004 Pn

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No