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

Ongoing
Research institutions and networks

Institutions

IQVIA
United Kingdom
First published:
22/04/2024
Institution Non-Pharmaceutical company ENCePP partner

Contact details

Fabian Hoti

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
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)