Abstract
Introduction: Roflumilast (ROF) is approved by the European Medicines Agency for maintenance treatment of severe COPD associated with chronic bronchitis and a history of frequent exacerbations as add on to inhalation treatment. The aim of the Patient registry of ROFlumilast In real LifE (PROFILE) study was to capture real-world data on the use of ROF in standard clinical practice.
Methods: PROFILE (ClinicalTrials.gov:NCT02015767) was an observational, non-interventional, non-comparative, prospective patient registry study. Patients initiating ROF were identified and followed for 1 year according to usual clinical practice. Data were collected at 3-monthly intervals. The primary outcome was the incidence and frequency of COPD exacerbations over 1 year.
Results: 1473 patients were enrolled from 5 European countries (Bulgaria, Germany, Greece, Norway and Slovakia), of whom 1222 had valid records. Patients were of median age 67 years, predominantly male (71.4%), had severe/very severe airflow limitation (71.4%/10.5%) and experienced a median of 2 COPD exacerbations (5–95% percentile 0–8) in the prior year. The most common reasons for starting ROF were COPD progression (62.7%), high exacerbation rate (56.5%) and inadequate response to therapy (46.4%). During the 1-year follow-up, 214 (17.5%) patients had 316 COPD exacerbations (69 had >1 exacerbation); the median number of exacerbations was 0 (5–95% percentile 0–2). There were no significant differences in exacerbation rate between COPD phenotypes (emphysema, chronic bronchitis and combined phenotype).
Conclusions: These results suggest that the use of ROF in standard clinical practice may reduce the frequency of COPD exacerbations.
- Copyright ©the authors 2017
