Status:
COMPLETED
Long-term Observational Study of the Safety of Roflumilast
Lead Sponsor:
AstraZeneca
Conditions:
COPD
Eligibility:
All Genders
40+ years
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 prop...
Detailed Description
Rationale and background Roflumilast is licensed (i) for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with...
Eligibility Criteria
Inclusion
- Exposed Cohort selection
- Inclusion Criteria:
- 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.
- Non-Exposed Cohort selection Patients meeting the following inclusion criteria belong in the Non-Exposed Cohort and are eligible as Matched Non-Exposed controls. Each patient in the Non-exposed Cohort selected as matched exposed patient is assigned as a Cohort Entry Date the date of the first roflumilast prescription of the matched exposed patient.
Exclusion
Key Trial Info
Start Date :
December 15 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 16 2022
Estimated Enrollment :
135856 Patients enrolled
Trial Details
Trial ID
NCT03381573
Start Date
December 15 2013
End Date
September 16 2022
Last Update
September 26 2023
Active Locations (4)
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1
Research Site
Cambridge, Massachusetts, United States, 02139
2
Research Site
Bremen, Germany
3
Research Site
Oslo, Norway, 0483
4
Research Site
Solna, Sweden