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Patient Registry of Roflumilast In Real Life

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AstraZeneca

Status

Completed

Conditions

Chronic Obstructive Pulmonary Disease

Study type

Observational

Funder types

Industry

Identifiers

NCT02015767
RO-2455-407-RD
U1111-1146-5619 (Other Identifier)

Details and patient eligibility

About

A patient registry to capture real life data and demonstrate the performance of roflumilast (Daxas®) in a standard clinical practice.

Full description

The drug being tested in this observational study design is called roflumilast, but not as an therapeutic intervention. Roflumilast is approved for and marketed globally for maintenance treatment of severe Chronic Obstructive Pulmonary Disease (COPD) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment.

This study will capture real life data and demonstrate the performance of roflumilast in a standard clinical practice. The study will enroll approximately 1350 (EU)+600(North Asia) patients. This multi-centre trial will be conducted in at least 4 EU and 2 North Asian countries.

The overall time to participate in this study is 12 months. No visits, diagnostic procedures or monitoring will take place, which would not happen had the patient not been included in the study.

Participants will be followed according to usual practice and data recorded approximately at 6 months and at 12 months of roflumilast treatment.

Enrollment

1,950 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Signed informed consent to the data collection
  • Roflumilast (Daxas®) treatment initiated in Roflumilast (Daxas®) naïve patients at the time of registry

Exclusion criteria

There are no exclusion criteria per se. However it is expected that patients are treated according to locally approved marketing authorisation.

Trial design

1,950 participants in 1 patient group

Roflumilast
Description:
Participants prescribed roflumilast (Daxas®) according to local guidelines and marketing authorization.

Trial contacts and locations

52

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Data sourced from clinicaltrials.gov

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