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A Drug Utilisation Post-authorisation Study of New Users of Aclidinium Bromide (Monotherapy or in Combination)

NCT03333018 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 22155

Last updated 2018-02-22

No results posted yet for this study

Summary

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.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Aclidinium bromide

Administered as monotherapy, prescribed as recorded in the database.

DRUG

Aclidinium bromide/formoterol

Administered in combination with formoterol fumarate (concomitant or as a fixed-dose combination), 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.

Sponsors & Collaborators

  • RTI Health Solutions

    collaborator OTHER

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Jordi Castellsague, MD, MPH · RTI Health Solutions

  • Susana Perez-Gutthann, MD, PhD · RTI Health Solutions

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-06
Primary Completion
2017-02-28
Completion
2017-02-28

Countries

  • Denmark
  • Germany
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03333018 on ClinicalTrials.gov