Status: Finalised First registered on: 15/05/2014
Last updated on: 26/01/2021
1. Study identification
EU PAS Register NumberEUPAS6559
Official titleAclidinium Bromide Drug Utilisation Post-Authorisation Safety Studies (DUS): Common Protocol for Aclidinium (DUS1) and Aclidinium/Formoterol Fixed-Dose Combination (DUS2)
Study title acronym
Study typeObservational study
Brief description of the studyAclidinium 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.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableD6560R00005 (DUS1 - Eklira), and D6570R00002 (DUS2- Duaklir)
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/Homepagewww.rtihs.org
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
Multiple centres

In total how many centres are involved in this Study?3

Countries in which this study is being conducted
International study

Denmark
Germany
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed02/12/201310/01/2014
Start date of data collection30/06/201506/07/2015
Start date of data analysis14/07/201526/08/2015
Date of interim report, if expected31/03/201718/05/2017
Date of final study report29/05/202012/03/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAlmirall, S.A./AstraZeneca AB100
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)34933622807 
Alternative phone number 
Fax number (incl. country code)34934142610 
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)34933622807 
Alternative phone number 
Fax number (incl. country code)34934142610 
Email address crebordosa@rti.org 
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