Study identification

PURI

https://redirect.ema.europa.eu/resource/104157

EU PAS number

EUPAS104156

Study ID

104157

Official title and acronym

Real-world use of Breztri/Trixeo for the management of COPD in a UK primary care population

DARWIN EU® study

No

Study countries

United Kingdom

Study description

Background/Rationale: The current, stepwise management approach of patients with stable chronic obstructive pulmonary disease (COPD) involves the use of long-acting beta-agonists (LABA), long-acting muscarinic antagonists (LAMA), and/or inhaled corticosteroids (ICS) depending on patients’ disease severity and symptomatology. In particular, dual therapies, namely LAMA+LABA or ICS+LABA, are recommended for highly symptomatic patients with moderate to severe COPD. Nonetheless, some patients remain symptomatic and suffer from exacerbations despite using dual therapies. Hence, recent years have seen the emergence of triple therapies (LABA+LAMA+ICS), such as budesonide/glycopyrrolate/formoterol (Breztri/Trixeo). Following demonstration of efficacy by randomized controlled trials, Breztri/Trixeo has been approved by the United States’ Food and Drug Administration on 23rd July 2020,7 and by the European Medicines Agency on 9th December 2020. Nevertheless, as a new medication, real-life evidence underlying the safety, acceptability, and efficacy of Breztri/Trixeo is lacking. Given that findings from randomized controlled trials may only be applicable to a subset of patients in real life, this study seeks to investigate the patient acceptability and describe clinical outcomes of Breztri/Trixeo amongst patients with COPD in the early period after launch using a large general practice database in the United Kingdom. Objective: To describe the acceptability and clinical outcomes of Breztri/Trixeo amongst patients with COPD.

Study status

Planned
Research institutions and networks

Institutions

Contact details

David Price

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Astra Zeneca
Study protocol
Initial protocol

Protocol v6.2

English (2.04 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable