MulTinational database cohoRt study to assess adverse cardIovascular and cereBrovascular outcomes in patiEnts (TRIBE) with chronic obstructive pulmonary disease

Study identification

• EU PAS number:
  EUPAS47420
• Study ID:
  47421
• Official title and acronym:
  MulTinational database cohoRt study to assess adverse cardIovascular and cereBrovascular outcomes in patiEnts (TRIBE) with chronic obstructive pulmonary disease
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Finland

  Germany

  Netherlands

  Norway

  Sweden

  United Kingdom
• Study description:
  TRIBE is a non-interventional, multicountry post-authorization safety study (PASS) based on retrospectively collected data. The study will be conducted to investigate the incidence of adverse cardiovascular and cerebrovascular events among patients with chronic obstructive pulmonary disease (COPD) treated Fixed triple therapy containing beclometasone dipropionate, formoterol fumarate and glycopyrronium administered via DPI (drug of interest), and with patients treated with Fixed triple therapy containing beclometasone dipropionate, formoterol fumarate and glycopyrronium administered via pMDI (comparator). All data will be collected from pre-existing large longitudinal healthcare databases from 7 countries with secondary use of data. The study will start from the date of the first launch of Fixed triple therapy containing beclometasone dipropionate, formoterol fumarate and glycopyrronium administered via DPI within the study countries and will continue for up to end of 2026. Interim and progress reports will be produced yearly until the end of 2027 when final study report will be delivered.
• Study status:
  Planned

Research institutions and networks

Institutions

IQVIA

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 01/06/2021

Actual: 01/06/2021

Study start date

Planned: 31/12/2022

Data analysis start date

Planned: 31/12/2023

Date of interim report, if expected

Planned: 31/05/2023

Date of final study report

Planned: 31/12/2027

Sources of funding

Other

More details on funding

Chiesi Farmaceutici S.p.A

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)