RT Journal Article
SR Electronic
T1 Health and functional status of tiotropium/olodaterol-treated patients with COPD: results from the AERIAL® non-interventional study
JF ERJ Open Research
JO erjor
FD European Respiratory Society
SP 00004-2021
DO 10.1183/23120541.00004-2021
A1 Adrian Gillissen
A1 Andrea Marseille
A1 Dirk Skowasch
A1 John Ritz
A1 Muriel Mattiucci-Guehlke
A1 Stefan Pabst
A1 Timm Greulic
A1 Rembert Koczulla
YR 2021
UL http://openres.ersjournals.com/content/early/2021/06/25/23120541.00004-2021.abstract
AB Patients with chronic obstructive pulmonary disease (COPD) often have reduced physical activity, which can impair health status. Real-world data can provide valuable information on the health and functional status of patients with COPD treated with tiotropium/olodaterol.AERIAL® (NCT03165045) was a German, non-interventional study of patients with COPD receiving treatment with tiotropium/olodaterol under real-world conditions for approximately 6 weeks. The primary endpoint was the proportion of patients achieving a decrease of ≥0.4 points in Clinical COPD Questionnaire (CCQ) score. The CCQ-4 subdomain was used to assess functional status, and the Physician's Global Evaluation (PGE) scale to assess the patients’ general condition. Safety was also assessed, as well as patient satisfaction and willingness to continue treatment.Of 1351 screened patients, 1322 were treated and 1140 comprised the full analysis set. The primary endpoint was met: 66.3% of patients achieved a ≥0.4-point decrease in overall CCQ score (mean decrease±standard deviation [sd] 0.78±0.95). Mean decrease ±sd in CCQ symptoms and functional state subdomains were 0.84±1.06 and 0.75±1.05 points, respectively. PGE scores improved. One fatality (not treatment-related) and 23 drug-related adverse events were recorded, most commonly nausea and vertigo. Over 85% of patients were satisfied/very satisfied with tiotropium/olodaterol overall and with the Respimat device, both in terms of inhalation and handling. Most patients (95.2%) expressed willingness to continue treatment.Patients with COPD treated with tiotropium/olodaterol via Respimat in routine clinical practice had clinically relevant improvements in health and functional status compared with baseline.FootnotesThis manuscript has recently been accepted for publication in the ERJ Open Research. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJOR online. Please open or download the PDF to view this article.Conflict of interest: Dr. Gillissen reports non-financial support from Boehringer Ingelheim, during the conduct of the study.Conflict of interest: Dr. Marseille reports other from Boehringer Ingelheim during the conduct of the study.Conflict of interest: Dr. Skowasch reports personal fees from Boehringer Ingelheim, personal fees from AstraZeneca, personal fees from Berlin-Chemie, personal fees from GSK, personal fees from Grifols, personal fees from Novartis, outside the submitted work.Conflict of interest: Dr. Ritz reports other from Boehringer Ingelheim, during the conduct of the study.Conflict of interest: Dr. Mattiucci-Guehlke is an employee of Boehringer Ingelheim.Conflict of interest: Dr. Pabst has nothing to disclose.Conflict of interest: Dr. Greulich reports personal fees from AstraZeneca, personal fees from Berlin-Chemie, personal fees from Boehringer-Ingelheim, personal fees from Chiesi, grants and personal fees from CSL-Behring, grants and personal fees from Grifols, personal fees from GSK, personal fees from Novartis, personal fees from Roche, outside the submitted work.Conflict of interest: Dr. Koczulla has nothing to disclose.