Comparative effectiveness of triple therapy in COPD: A new-user cohort study

Study identification

• EU PAS number:
  EUPAS26211
• Study ID:
  28740
• Official title and acronym:
  Comparative effectiveness of triple therapy in COPD: A new-user cohort study
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  The treatment of COPD involves multiple therapies, including long-acting bronchodilators (LAMAs and LABAs) and inhaled corticosteroids (ICS), with dual combinations of these drugs now formulated into single inhalers. Recently, several single-inhaler triple therapies involving an LABA-LAMA-ICS combination are being developed and being tested for effectiveness in randomized trials. The TRILOGY and TRINITY trials compared a single-inhaler triple therapy with an LABA-ICS and a LAMA respectively and found greater benefit with triple therapy. The TRIBUTE trial and ongoing IMPACT trial also compare triple therapy with a dual long-acting bronchodilator regimen (LABA-LAMA). These trials, however, have methodological issues related to the deleterious effect of withdrawal of maintenance treatment at randomization, the use of run-in periods and the truncated follow-up at treatment discontinuation. Moreover, they represent a limited view of the patients who could potentially use these treatments, so that a real-world study of patients who are representative of clinical practice is of interest.As many of these drugs have been in use in separate inhalers for many years, an observational study of the comparative effectiveness of triple therapy is feasible and would provide useful data on the relative benefits of different combinations in the treatment of COPD. The intended audience is payers and prescribers. The results from the study will be published in the scientific literature.
• Study status:
  Ongoing

Research institutions and networks

Institutions

McGill University

Center for Clinical Epidemiology

Study timelines

Date when funding contract was signed

Planned:23/01/2017

Actual:23/01/2017

Study start date

Planned:10/11/2018

Actual:10/11/2018

Data analysis start date

Planned:12/11/2018

Actual:12/11/2018

Date of final study report

Planned:31/05/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim International GmbH

Regulatory

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