Overview

This trial is active, not recruiting.

Condition chronic obstructive pulmonary disease
Sponsor Takeda
Start date February 2013
End date March 2016
Trial size 1950 participants
Trial identifier NCT02015767, RO-2455-407-RD, U1111-1146-5619

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Participants prescribed roflumilast (Daxas®) according to local guidelines and marketing authorization.

Primary Outcomes

Measure
Number of observed exacerbations
time frame: 12 months

Secondary Outcomes

Measure
Severity of exacerbations
time frame: 12 months
Seasonal variation of exacerbation
time frame: 12 months
Number of hospitalizations due to COPD exacerbations
time frame: 12 months
Change from Baseline in lung function parameters (FEV1 and FEV1/FVC)
time frame: Baseline and Month 12
Change from Baseline in blood oxygen saturation
time frame: Baseline and Month 12
Percentage of compliance to treatment
time frame: 12 months
Changes in concomitant administration of COPD maintenance treatments
time frame: 12 months
Health status using the COPD Assessment Questionnaire (CAT)
time frame: Baseline, Month 6 and Month 12
Change from Baseline in breathlessness
time frame: Baseline and Month 12
Number of Participants with adverse Drug Reactions (ADRs)
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Patient Registry of Roflumilast In Real Life
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Takeda.