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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

94 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-15

Study Completion Date

2022-06-09

Brief Summary

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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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Detailed Description

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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.

Conditions

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COPD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COPD patients

Trimbow 87/5/9 pMDI for COPD prescribed according to licensed indication

Non-interventional

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No