Study identification

PURI

https://redirect.ema.europa.eu/resource/42316

EU PAS number

EUPAS13616

Study ID

42316

Official title and acronym

Aclidinium Bromide Post-Authorisation Safety Study to Evaluate the Risk of Cardiovascular Endpoints

DARWIN EU® study

No

Study countries

United Kingdom

Study description

Aclidinium bromide is a long-acting and potent antagonist of lung M3 receptors indicated as a maintenance bronchodilator treatment to relieve symptoms in adults age 40 or older with chronic obstructive pulmonary disease (COPD). To evaluate potential cardiovascular safety concerns and all-cause mortality identified in the European risk management plan for aclidinium bromide, a PASS will be conducted through sequential studies for the endpoints of interest. Specific aims are: --To compare the risk of congestive heart failure, acute myocardial infarction, stroke, and all-cause mortality in patients with COPD initiating treatment with aclidinium bromide (monotherapy or combination therapy with formoterol (not fixed-dose and fixed-dose) and other COPD medications with the risk in patients with COPD initiating treatment with long-acting beta-agonists (LABAs). --To compare the risk of the study endpoints of interest in patients with COPD initiating treatment with aclidinium bromide (monotherapy or combination with formoterol, not fixed-dose and fixed-dose) with the risk in patients with COPD initiating treatment with other COPD medications. --To evaluate the effect of dose and duration of each study medication on the risk of each study outcome. --To compare the risk of cardiac arrhythmias in patients with COPD between: 1) New users of fixed-dose combination of aclidinium and formoterol and other fixed-dose combination COPD medications with new users of LABA, 2) New users of fixed-dose combination of aclidinium and formoterol with new users of each of the other fixed-dose combination COPD medications. The first and second nested case-control and cohort studies, initiated in March 2016 and February 2017, evaluate the risk of all-cause mortality and congestive heart failure. Sample size considerations will trigger the start of three additional cohort studies evaluating the risk of acute myocardial infarction, stroke, and cardiac arrhythmias

Study status

Ongoing
Research institution and networks

Institutions

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
19/02/2024
Institution
Not-for-profitENCePP partner

Contact details

Cristina Rebordosa

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Start date of data analysis

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

AstraZeneca
Study protocol
Initial protocol

PASS_PROTOCOL_COMBO_2Jun2015_V 2.2_Redacted2

English (1.72 MB - PDF)View document
Updated protocol

D6560R00004 PASS protocol v4 signed_redacted

English (1.87 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 1 (imposed as condition of marketing authorisation)