Study type

Study type

Non-interventional study

Scope of the study

Drug utilisation
Safety study (incl. comparative)
Non-interventional study

Non-interventional study design

Case-control
Study drug and medical condition

Name of medicine

Bretaris
Bretaris Genuair 400 µg - Inhalation powder, pre-dispensed
Brimica
Brimica Genuair 340 µg + 12 µg - Inhalation powder
Duaklir
Duaklir Genuair 340 µg + 12 µg - Inhalation powder
Eklira
Eklira Genuair 322 µg - Inhalation powder, pre-dispensed

Study drug International non-proprietary name (INN) or common name

ACLIDINIUM BROMIDE
FORMOTEROL FUMARATE DIHYDRATE

Anatomical Therapeutic Chemical (ATC) code

(R03AC12) salmeterol
(R03AC13) formoterol
(R03AC18) indacaterol
(R03AC19) olodaterol
(R03AK06) salmeterol and fluticasone
(R03AK07) formoterol and budesonide
(R03AK07) formoterol and budesonide
(R03AL03) vilanterol and umeclidinium bromide
(R03AL04) indacaterol and glycopyrronium bromide
(R03AL05) formoterol and aclidinium bromide
(R03AL06) olodaterol and tiotropium bromide
(R03AL07) formoterol and glycopyrronium bromide
(R03BB04) tiotropium bromide
(R03BB05) aclidinium bromide
(R03BB06) glycopyrronium bromide
(R03BB07) umeclidinium bromide

Medical condition to be studied

Chronic obstructive pulmonary disease
Population studied

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

105000
Study design details

Main study objective

To compare the risk of all-cause mortality, congestive heart failure, acute myocardial infarction, stroke, and cardiac arrhythmias in patients with COPD initiating treatment with aclidinium bromide with the risk in patients with COPD initiating other treatments for COPD.

Outcomes

All-cause mortality, congestive heart failure, acute myocardial infarction, stroke, and cardiac arrhythmias.

Data analysis plan

A descriptive analysis of the study cohorts will be performed. Crude and age and sex- standardized incidence rates will be estimated for each study cohort. A cohort analysis will be performed to estimate crude and adjusted relative risks (RRs) and 95% CIs for each study endpoint using conditional multiple logistic regression to compare:--Current, recent, and past use of aclidinium and of each study medication with current use of LABAs--Current single use of aclidinium and of each study medication with current single use of LABAs--Current single use of aclidinium with current single use of each study medication. Analyses will also be performed stratified by specific subgroups of patients (e.g. by COPD severity, age groups, or history of cardiovascular disease) among current users of the study medications. The effect of dose and duration of use will be estimated among current single users of each study medication.
Documents
Study publications
A Cohort Study to Evaluate the Risk of Hospitalisation for Congestive Heart Fai…
Are you really dead? Validation of death and date of death in patients with COP…
Hospitalization for heart failure among patients using aclidinium bromide and o…
Use of aclidinium did not increase the risk of death in a noninterventional coh…
A validation exercise: identifying hospitalizations for heart failure among pat…