Aclidinium Bromide Post-Authorisation Safety Study to Evaluate the Risk of Cardiovascular Endpoints (PASS)

  • STATUS
    Recruiting
  • End date
    Jan 31, 2023
  • participants needed
    31881
  • sponsor
    AstraZeneca
Updated on 8 June 2022
bromide
aclidinium bromide

Summary

The purpose of this study is to evaluate the potential cardiovascular safety concerns and all-cause mortality described in the risk management plan for aclidinium bromide, through sequential, nested case-control studies for each endpoint of interest

Description

This is a post-authorisation safety study (PASS) of new users of aclidinium bromide, fixed dose aclidinium bromide/formoterol fumarate dihydrate, and other inhaled medications frequently used by patients with COPD.

The plan is for the PASS study to be conducted on one population-based automated health database; the initial candidate database is the CRPD in the United Kingdom.

Details
Condition Pulmonary Disease, Chronic Obstructive
Treatment Aclidinium bromide, Other COPD medication
Clinical Study IdentifierNCT03290287
SponsorAstraZeneca
Last Modified on8 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Have at least 1 year of enrolment in the electronic database. In the CPRD, only patients with permanent registration status in "up to standard" participant general practices will be included in the cohort
Be aged 40 years or older
Have a recorded diagnosis of COPD
Have not been prescribed a study medication of interest during the 6 months before the date of the first prescription for that specific study medication

Exclusion Criteria

Patients with cancer or other serious, non-cardiovascular, life-threatening conditions or indicators of severe comorbidity will be excluded from the study cohort
Subjects who will be potentially excluded are those with the following conditions recorded in the database at any time before the date of cohort entry: cancer, HIV, respiratory failure, end-stage renal disease or dialysis, organ transplantation, drug or alcohol abuse, coma, congenital abnormalities of the heart or great arteries
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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