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Completed

NCT Number: NCT04355546

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

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.

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Key information

Age range

35 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Liverpool Heart and Chest Foundation Trust

Liverpool, L14 3PE, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with moderate to severe COPD (with and without concomitant asthma)
  • 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
  • Patients with at least one COPD exacerbation within the previous 12 months
  • Patients willing and able to sign informed consent for use of their pseudonymised clinical data within the present Non-Interventional Trial

Exclusion criteria

  • Patients hospitalised due to an exacerbation of their COPD within the last 4 weeks prior to enrolment
  • Participation within an interventional clinical trial within 30 days prior to enrolment into the present Non-Interventional Trial

Treatment and study plan

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.

Primary outcomes

  1. Assess change in health related quality of life in COPD patients prescribed Trimbow

    Time frame: 6 months

    Change in total CAT score between baseline and after 6 months of treatment.

Secondary outcomes

  1. Assess adherence to COPD therapy

    Time frame: 6 months

    changes in adherence scores (assessed by means of TAI questionnaire),

  2. changes in relevant spirometry parameters

    Time frame: 6 months

    between baseline, e.g. FEV1, FVC

  3. incidence of clinical events

    Time frame: 6 months

    e.g. exacerbations

  4. Compare requirement of rescue medication and alteration of COPD therapy

    Time frame: 6 months

    incidence of COPD medication changes and rescue medication use medication changes and rescue medication use

Sponsors and collaborators

Lead sponsor

Chiesi UK

Industry

Collaborators

  • Liverpool Heart and Chest Hospital NHS Foundation Trust

Registry information

Official study 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

Acronym: TriOptimize

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 21, 2020
Registry last updated
Aug 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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