A drug utilisation post-authorisation study of new users of aclidinium bromide (monotherapy or in combination) - DUS1/DUS2
Study identifier:D6560R00005
ClinicalTrials.gov identifier:NCT03333018
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
Aclidinium Bromide Drug Utilisation Post-Authorisation Safety Studies (DUS): Common Protocol for Aclidinium (DUS1) and Aclidinium/Formoterol Fixed-Dose Combination (DUS2)
Medical condition
Pulmonary Disease, Chronic Obstructive
Phase
N/A
Healthy volunteers
No
Study drug
Aclidinium bromide, Aclidinium bromide/formoterol, Other COPD medication
Sex
All
Actual Enrollment
22155
Study type
Observational
Age
N/A
Date
Study Start Date: 06 Jul 2015
Primary Completion Date: 28 Feb 2017
Study Completion Date: 28 Feb 2017
Study design
Allocation: -
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verification:
Verified 01 Feb 2018 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
RTI Health Solutions
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Aclidinium bromide monotherapy In DUS1, all new users of aclidinium either on monotherapy or with concomitant formoterol will be included. In addition, in DUS2, all new users of the fixed-dose combination of aclidinium/formoterol and any other new fixed-dose combinations of LAMAs and LABAs that become available during the study and that are captured in each database will be included. | Drug: Aclidinium bromide Administered as monotherapy, prescribed as recorded in the database. |
| Aclidinium bromide and formoterol In DUS1, all new users of aclidinium either on monotherapy or with concomitant formoterol will be included. In addition, in DUS2, all new users of the fixed-dose combination of aclidinium/formoterol and any other new fixed-dose combinations of LAMAs and LABAs that become available during the study and that are captured in each database will be included. | Drug: Aclidinium bromide/formoterol Administered in combination with formoterol fumarate (concomitant or as a fixed-dose combination), prescribed as recorded in the database. |
| New users of other COPD medication New users of other COPD medications (tiotropium, other LAMAs, LABA, LABA/ICS, LAMA/LABA), prescribed as recorded in the database. | Drug: Other COPD medication Other COPD medication including: tiotropium; other long-acting anticholinergic (LAMAs; lycopyrronium bromide, umeclidinium); LABA (formoterol, salmeterol, indacaterol); LABA/ICS (formoterol/budesonide, formoterol/beclometasone, formoterol/mometasone, formoterol/fluticasone, salmeterol/fluticasone propionate, and vilanterol/fluticasone); LAMA/LABA (approved or under regulatory review or in development; glycopyrrolate/formoterol, glycopyrronium/indacaterol, tiotropium/olodaterol, umeclidinium/vilanterol), prescribed as recorded in the database. |
Contacts
Investigators
Principal Investigator
Jordi Castellsague
RTI Health Solutions
