Study identification

EU PAS number

EUPAS6559

Study ID

39222

Official title and acronym

Aclidinium Bromide Drug Utilisation Post-Authorisation Safety Studies (DUS): Common Protocol for Aclidinium (DUS1) and Aclidinium/Formoterol Fixed-Dose Combination (DUS2)

DARWIN EU® study

No

Study countries

Denmark
Germany
United Kingdom

Study description

Aclidinium bromide is a long-acting antagonist of lung M3 receptors used as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD. For a post-authorization safety study, a multinational database drug utilisation study (DUS1) in a cohort of new users of aclidinium bromide and new users of other inhaled medications frequently used by patients with COPD will be implemented. DUS2 will begin when the fixed-dose combination of aclidinium bromide/formoterol fumarate becomes available. DUS1/DUS2 objectives are: • To describe the characteristics and patterns of use of new users of aclidinium bromide (monotherapy or in combination with formoterol) and new users of other COPD medications. • To evaluate the potential off-label use of aclidinium bromide • To describe users of aclidinium bromide in subgroups of patients for whom there is missing information in the RMP • To establish a core cohort of new users of aclidinium bromide for the future evaluation of safety concerns described in the RMP The study is planned in the Clinical Practice Research Datalink, the German Pharmacoepidemiological Database, and the national health databases in Denmark. DUS1/DUS2 are non-interventional cohort studies of new users of aclidinium bromide (monotherapy or in combination, respectively), tiotropium, LABA, and LABA+ICS who will be characterised 1) at the index date according to prior clinical information and prior and concurrent use of medications and 2) during the year following the index date to assess patterns of use. All available new users of aclidinium bromide or of the fixed-dose combination of aclidinium/formoterol at study initiation in each database will be included. The estimated study target is 1,500-2,000 new users of aclidinium bromide (for DUS1,the fixed-dose combination of aclidinium/formoterol for DUS2) and a sample of 2,000 new users of each comparator in each country-specific database.

Study status

Finalised
Research institutions and networks

Institutions

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
13/03/2025
Institution Not-for-profit ENCePP partner
Multiple centres: 3 centres are involved in the study

Contact details

Cristina Rebordosa

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
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Data analysis start date

Planned:
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Date of interim report, if expected

Planned:
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Date of final study report

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Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Almirall, S.A./AstraZeneca AB
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)