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

Completed

• Conditions: COPD
• Interventions: Other: Non-interventional

• Registration Number: NCT04355546
• Lead Sponsor: Chiesi UK

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.

Study Timeline

• Study First Submitted: 2020-04-20
• Study First Submitted QC: 2020-04-20
• Study First Posted: 2020-04-21
• Study Start: 2020-07-15
• Primary Completion: 2022-06-09
• Study Completion: 2022-06-09
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-01
• Last Update Posted: 2023-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COPD patients	Non-interventional	Trimbow 87/5/9 pMDI for COPD prescribed according to licensed indication

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
changes in relevant spirometry parameters	6 months	between baseline, e.g. FEV1, FVC
incidence of clinical events	6 months	e.g. exacerbations
Assess adherence to COPD therapy	6 months	changes in adherence scores (assessed by means of TAI questionnaire),

Trial Locations

Locations (1)

Liverpool Heart and Chest Foundation Trust; 🇬🇧 Liverpool, United Kingdom