Status:
COMPLETED
A Drug Utilisation Post-authorisation Study of New Users of Aclidinium Bromide (Monotherapy or in Combination)
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
RTI Health Solutions
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
Brief Summary
DUS1 and DUS2 are descriptive drug utilisation studies in new users of aclidinium bromide in Europe. The objectives of DUS1 and DUS2 are to describe the characteristics and patterns of use of new use...
Detailed Description
DUS1 will be conducted when the target number of new users of aclidinium monotherapy is reached, and DUS2 when the target number of new users of aclidinium fixed-dose combination with formoterol is re...
Eligibility Criteria
Inclusion
- Patients in the study will be required to meet the following criteria, as ascertained from each of the automated databases:
- To have at least 1 year of enrolment in the database (DUS1 and DUS2).
- To have not been prescribed aclidinium bromide as monotherapy or with concomitant use of formoterol during the 6 months before the date of first prescription of aclidinium bromide (index date) in DUS1
- To have not been prescribed aclidinium bromide as monotherapy, with concomitant use of formoterol, or as aclidinium/formoterol during the 6 months before the date of first prescription of aclidinium bromide (index date) in DUS2
- The same inclusion criteria will be applied for each of the comparator drugs.
Exclusion
- No age restrictions or exclusion criteria will be applied. This will allow for the characterisation of all users of aclidinium bromide and comparator drugs irrespective of the indication for which these medications are used. Identification of potential off-label use of aclidinium bromide in the paediatric and adult populations is one of the specific objectives of this DUS.
Key Trial Info
Start Date :
July 6 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2017
Estimated Enrollment :
22155 Patients enrolled
Trial Details
Trial ID
NCT03333018
Start Date
July 6 2015
End Date
February 28 2017
Last Update
February 22 2018
Active Locations (3)
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1
National Health Database Denmark, Southern Denmark University
Odense, Denmark
2
German Pharmacoepidemiological Research Database
Bremen, Germany
3
Clinical Practice Research Datalink
London, United Kingdom