Long-term Observational Study of the Safety of Roflumilast

Part of paid clinical trials in Cambridge, Massachusetts.

Sponsor: AstraZeneca
Study ID: NCT03381573
Status: Completed

Conditions

COPD

Eligibility Criteria

Sex: ALL
Age: 40 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Roflumilast — DRUG
Roflumilast

Study Details

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.