Pneumologie 2013; 67 - P407
DOI: 10.1055/s-0033-1334738

Symptom assessment by means of the COPD-Assessment Test (CAT) in patients treated with Roflumilast – a 6 month non-interventional study

P Kardos 1, TD Bethke 2, C Vogelmeier 3
  • 1Private Practice, Frankfurt a.M.
  • 2Medidata GmbH
  • 3Universitätsklinikum Marburg, Zentrum für Innere Medizin

Background: Symptom improvement is important in patients with chronic obstructive pulmonary disease (COPD). The purpose of this prospective, single-arm non-interventional study was to investigate the effects of the anti-inflammatory PDE-4 inhibitor roflumilast 500 µg once daily on symptoms of COPD in routine clinical care. For this purpose, the COPD Assessment Test™ (CAT) was used.

Methods: 3597 patients (male: 65.2%; mean age: 65.5 ± 9.9 years; mean BMI 27.3 ± 5.7 kg/m2) were enrolled in 739 study centres in Germany in the year 2011 and treated with roflumilast 500 µg once daily for up to 6 months (intention-to-treat, ITT). Eligible patients had to suffer from severe COPD (post-bronchodilator FEV1 < 50% predicted) associated with chronic bronchitis and a history of frequent exacerbations. Roflumilast was given as add-on therapy to bronchodilators. CAT was analysed in 3143 ITT patients at the start of the study (V1), in 1895 patients after 3 months (V2), and in 1791 patients after 6 months (V3). A per-protocol (PP) population was also evaluated (V1: N = 891; V2: N = 685; V3: N = 756).

Results: Mean (± SD) post-bronchodilator lung function data at V1 indicated predominantly severe COPD: FEV1 44.7%± 15.8% (N = 2093), FEV1/FVC 57.4 ± 16.5% (N = 1990). At baseline (V1), the mean CAT scores were 25.4 ± 6.9 (ITT) and 26.4 ± 6.5 (PP), indicating relevant health status impairment. After 3 months, the mean changes in CAT score were -3.7 ± 5.8 (ITT) and -4.2 ± 5.7 (PP); after 6 months, the mean changes in CAT score were -5.8 ± 7.3 (ITT) and -6.4 ± 7.3 (PP). All changes were statistically significant from baseline (p < 0.001, ITT and PP; Wilcoxon signed rank test).

Conclusions: Under add-on therapy with roflumilast, COPD symptoms measured by the CAT improved significantly in a real-life patient population with COPD after 3 months and more pronounced after 6 months. Non-interventional studies have well known limitations, but reflect routine medical care in daily practice.