Comparative effectiveness of combination therapies in COPD

Study identification

• EU PAS number:
  EUPAS21699
• Study ID:
  28232
• Official title and acronym:
  Comparative effectiveness of combination therapies in COPD
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  The treatment of COPD increasingly involves multiple therapies, including long-acting bronchodilators (LAMAs and LABAs) and inhaled corticosteroids (ICS), with combinations of these drugs now formulated into single inhalers. The use of ICS has increased disproportionately with respect to COPD treatment guidelines and may be inappropriate in a subset of these users. New evidence suggests that patients can be safely weaned off ICS, including the WISDOM trial that observed no difference in the risk of moderate or severe exacerbations between patients who discontinued ICS and those who continued receiving ICS. Moreover, discontinuation of ICS has been associated with a reduction in the risk of pneumonia. While most trials of the combination treatments have been conducted against the respective mono components or placebo, very few head-to-head trials versus other combinations have been performed to date. For example, the recent FLAME randomized trial reported that patients receiving the LABA-LAMA combination had fewer exacerbations than those receiving the LABA-ICS combination over a one-year follow-up period. Also, the ENERGITO trial reported significant improvements in lung function with a LAMA/LABA combination versus LABA/ICS in GOLD 2-3 patients after 6 weeks of treatment. These trials, however, represent a limited view of the patients who could potentially use these treatments, with many exclusion criteria based on for example stage of disease, lung function and exacerbation history, as well as exclusions of many patients during the screening and run-in periods. Thus, a real-world study of patients who are representative of clinical practice is of interest.
• Study status:
  Finalised

Research institutions and networks

Institutions

McGill University

Study timelines

Date when funding contract was signed

Planned:23/01/2017

Actual:23/01/2017

Study start date

Planned:01/12/2017

Actual:01/12/2017

Date of final study report

Planned:31/08/2018

Actual:01/10/2018

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

Other study registration identification numbers and links

0205-0538
NCT03376295