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Long-term Observational Study of the Safety of Roflumilast

NCT03381573 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 135856

Last updated 2023-09-26

No results posted yet for this study

Summary

This is a retrospective cohort study comparing COPD patients aged 40 years and older with new exposure to roflumilast with up to 5 unexposed (ie, not roflumilast-exposed) COPD controls matched by propensity score (PS), age, sex, and year of cohort entry. The study is using electronic healthcare databases in the US (Military Health System database), Germany (GER) (German Pharmacoepidemiological Research Database), and Sweden (SWE) (national databases including healthcare, death, and demographics data). The main objective of this study is to evaluate the long-term safety of roflumilast in the treatment of COPD with main focus on the primary outcome of all-cause mortality and evaluation of potential safety issues identified during the clinical trials of roflumilast. Crude mortality and incidence rates will be compared between roflumilast exposed and unexposed COPD patients and adjusted hazard ratios (HRs) of the primary and secondary outcomes will be calculated.

Conditions

Interventions

DRUG

Roflumilast

Roflumilast

Sponsors & Collaborators

Principal Investigators

  • Edeltraut Garbe, Dr. med. · Leibniz Inst for Prevention & Epidemiology - BIPS GmbH

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-15
Primary Completion
2022-09-16
Completion
2022-09-16

Countries

  • United States
  • Germany
  • Norway
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT03381573 on ClinicalTrials.gov