Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Aclidinium Bromide Drug Utilisation Post-Authorisation Safety Studies (DUS): Common Protocol for Aclidinium (DUS1) and Aclidinium/Formoterol Fixed-Dose Combination (DUS2)
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 users of aclidinium bromide (monotherapy or in combination) and new users of other
medications for chronic obstructive pulmonary disease (COPD); to evaluate the potential
off-label use of aclidinium bromide; to describe users of aclidinium bromide in subgroups of
patients for whom there is missing information in the risk management plan (RMP); and to
establish a core cohort of new users of aclidinium bromide for the future evaluation of
safety concerns described in the RMP.
The data source for these studies will be the CRPD in the UK, the GePaRD in Germany, and
national health databases in Denmark.
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 reached.
As this was a descriptive study no primary or secondary endpoints were specified.
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