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

Study identification

• 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

Observational & Pragmatic Research Institute Pte (OPRI)

United Kingdom

Study timelines

Date when funding contract was signed

Actual:24/10/2022

Study start date

Planned:01/11/2022

Data analysis start date

Planned:07/11/2022

Date of final study report

Planned:31/03/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Astra Zeneca

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

OPRI-2202, D5980R00073