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

COPD Clinical Trial

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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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04355546
• Other study ID #: NIS 004 Pn
• Status: Completed
• Start date: July 15, 2020
• Est. completion date: June 9, 2022

Study information

• Verified date: August 2023
• Source: Chiesi UK
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: June 9, 2022
• Est. primary completion date: June 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• COPD

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Liverpool Heart and Chest Foundation Trust	Liverpool

Sponsors (2)

Lead Sponsor	Collaborator
Chiesi UK	Liverpool Heart and Chest Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Assess adherence to COPD therapy	changes in adherence scores (assessed by means of TAI questionnaire),	6 months
Secondary	changes in relevant spirometry parameters	between baseline, e.g. FEV1, FVC	6 months
Secondary	incidence of clinical events	e.g. exacerbations	6 months
Secondary	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