Status: Ongoing First registered on: 27/05/2016
Last updated on: 08/12/2020
1. Study identification
EU PAS Register NumberEUPAS13616
Official titleAclidinium Bromide Post-Authorisation Safety Study to Evaluate the Risk of Cardiovascular Endpoints
Study title acronym
Study typeObservational study
Brief description of the studyAclidinium 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
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 1 (imposed as condition of marketing authorisation)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableD6560R00004
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsRTI-HS
Department/Research groupPharmacoepidemiology & Risk Management
Organisation/affiliationRTI Health Solutions
Website/Homepagehttps://www.rtihs.org/services/pharmacoepidemiology-and-risk-management
Details of (Primary) lead investigator
Title Dr
Last name Rebordosa
First name Cristina
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed29/02/201610/03/2016
Start date of data collection31/10/201627/01/2017
Start date of data analysis31/10/201716/10/2017
Date of interim report, if expected28/06/201906/06/2019
Date of final study report30/06/2023
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstraZeneca100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Rebordosa
First name Cristina
Address line 1Av. Diagonal 605, 9-1
Address line 2 
Address line 3 
CityBarcelona 
Postcode08028 
CountrySpain
Phone number (incl. country code)34932417763 
Alternative phone number 
Fax number (incl. country code)34937608507 
Email address crebordosa@rti.org
Public Enquiries
Title Dr 
Last name Rebordosa 
First name Cristina 
Address line 1Av. Diagonal 605, 9-1 
Address line 2 
Address line 3 
CityBarcelona 
Postcode08028 
CountrySpain 
Phone number (incl. country code)34932417763 
Alternative phone number 
Fax number (incl. country code)34937608507 
Email address crebordosa@rti.org 
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