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

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

Collaborators

RTI Health Solutions

Inclusion and exclusion criteria

Location

Clinical Practice Research Datalink

London, United Kingdom

Location

National Health Database Denmark, Southern Denmark University

Odense, Denmark

Location

German Pharmacoepidemiological Research Database

Bremen, Germany

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.

Documents available

CSR Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

Jordi Castellsague

RTI Health Solutions

A drug utilisation post-authorisation study of new users of aclidinium bromide (monotherapy or in combination) - DUS1/DUS2

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Clinical Practice Research Datalink

National Health Database Denmark, Southern Denmark University

German Pharmacoepidemiological Research Database

Documents available

CSR Synopsis

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator