Aclidinium Bromide Post-Authorisation Safety Study to Evaluate the Risk of Cardiovascular Endpoints - PASS
Study identifier:D6560R00004
ClinicalTrials.gov identifier:NCT03290287
EudraCT identifier:N/A
CTIS identifier:N/A
Recruiting
Official Title
Aclidinium Bromide Post-Authorisation Safety Study to Evaluate the Risk of Cardiovascular Endpoints: Common Study Protocol
Medical condition
Pulmonary Disease, Chronic Obstructive
Phase
N/A
Healthy volunteers
No
Study drug
Aclidinium bromide, Other COPD medication
Sex
All
Estimated Enrollment
31881
Study type
Observational
Age
40 Years - n/a
Date
Study Start Date: 01 Mar 2017
Estimated Primary Completion Date: 30 Dec 2022
Estimated Study Completion Date: 30 Dec 2022
Study design
Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verification:
Verified 01 Dec 2022 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
RTI Health Solutions
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| New users of aclidinium bromide This nested cohort will be composed of patients aged 40 years or older who have previously been diagnosed with COPD and who are new users of aclidinium bromide (monotherapy; concomitant with formoterol not in fixed-dose combination; and aclidinium/formoterol) | Drug: Aclidinium bromide Administered as monotherapy, concomitant with formoterol not in fixed-dose combination, or fixed-dose aclidinium/formoterol |
| New users of other COPD medication This nested cohort will include patients aged 40 years or older who have previously been diagnosed with COPD and who are new users of other COPD medication: tiotropium, other LAMAs, LABA, LABA/ICS and LAMA/LABA. | Drug: Other COPD medication Users of the following COPD medications: Tiotropium Other long-acting anticholinergic (LAMAs): glycopyrronium bromide, umeclidinium LABA: formoterol, salmeterol, indacaterol LABA/ICS (LABA in fixed-dose combinations with ICS): formoterol/budesonide, formoterol/beclometasone, formoterol/mometasone, formoterol/fluticasone, salmeterol/fluticasone, and vilanterol/fluticasone. LAMA/LABA (approved or under regulatory review or in development): glycopyrrolate/formoterol, glycopyrronium/indacaterol, tiotropium/olodaterol, umeclidinium/vilanterol |
