Long-term Observational Study of the Safety of Roflumilast

NCT03381573 | Completed

• 2 other identifiers: D7120R00003EUPAS14852
• Study Type: observational
• Target: 135,856
• Locations: 4 countries
• Sites: 4

Brief 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

COPD

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  Safety objective to estimate 5-year all-cause mortality

  up to 5 years

Secondary Outcomes (10)

• death by suicide or hospitalization for suicide attempt

  up to 5 years

• hospitalization for any cause

  up to 5 years

• Major cardiovascular events

  up to 5 years

• Respiratory disease related hospitalization

  up to 5 years

• New diagnoses of depression

  up to 5 years

Study Arms (2)

Roflumilast exposed

Patients with COPD ever exposed to Roflumilast

Drug: Roflumilast

Roflumilast unexposed

Patients with COPD never exposed to Roflumilast

Interventions

Roflumilast DRUG

Roflumilast

Roflumilast exposed

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

unselected COPD patients aged 40 years and older, reflecting the use of roflumilast in a real-life setting.

You may qualify if:

• Have one or more prescription(s) of roflumilast with the date of first prescription/dispensation defined as the Cohort Entry Date
• Have active data in the respective database(s) for at least 1 year prior to the Cohort Entry Date
• Be at least 40 years old at Cohort Entry Date
• Have a diagnosis of COPD or chronic bronchitis prior to the Cohort Entry Date (databases with outpatient diagnoses) or (databases without outpatient diagnoses) either a hospital diagnosis of COPD or chronic bronchitis prior to the Cohort Entry Date or a proxy for such indication based on prescription data.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (4)

Research Site

Cambridge, Massachusetts, 02139, United States

Location

Research Site

Bremen, Germany

Location

Research Site

Oslo, 0483, Norway

Location

Research Site

Solna, Sweden

Location

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Roflumilast

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Edeltraut Garbe, Dr. med.

  Leibniz Inst for Prevention & Epidemiology - BIPS GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: December 22, 2017
• Study Start: December 15, 2013
• Primary Completion: September 16, 2022
• Study Completion: September 16, 2022
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); SE (1); US (1); NO (1)