Pneumologie 2020; 74(S 01): 45
DOI: 10.1055/s-0039-3403162
Posterbegehung (PO08) – Sektion Klinische Pneumologie
Klinische Studien bei COPD und Asthma
Georg Thieme Verlag KG Stuttgart · New York

Changes in health and functional status in patients with COPD during therapy with Spiolto® Respimat®

B Schmorell
1   Praxis Dr. Schmorell
,
H Ingerl
2   Praxis Hermann Ingerl
,
W Gams
3   Praxis Dr. Med. Werner Gams
,
M Mattiucci-Gühlke
4   Boehringer Ingelheim Pharma GmbH & Co. Kg
,
A Marseille
4   Boehringer Ingelheim Pharma GmbH & Co. Kg
,
J Ritz
5   Boehringer Ingelheim Pharmaceuticals, Inc
,
A Gillissen
6   Med. Klinik III, Kreiskliniken Reutlingen/Ermstalsklinik Reutlingen-Bad Urach
› Author Affiliations
Further Information

Publication History

Publication Date:
28 February 2020 (online)

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    Aim: This non interventional study aimed to investigate health and functional status, satisfaction and willingness to continue treatment after study end in COPD patients treated with Spiolto® Respimat® in routine clinical practice.

    Method: This was an open-label observational study with COPD patients (GOLD group B – D) from mainly non-hospital sites in Germany treated with Spiolto® Respimat® for approximately 6 weeks. Health and functional status were assessed with the Clinical COPD Questionnaire (CCQ) with its subdomains symptoms, functional status (CCQ-4) and mental status. The primary endpoint was the proportion of patients achieving “therapeutic success”, defined as a 0.4 point decrease in the total CCQ score between baseline (visit 1) and visit 2 after approximately six weeks. Secondary endpoints were changes in total CCQ and CCQ-4 from visit 1 to visit 2, the patientʼs general condition at both visits assessed by Physicianʼs Global Evaluation (PGE) as well as willingness to continue Spiolto® Respimat® at visit 2 and patient satisfaction with the therapy.

    Results: 1351 patients were enrolled in 114 sites in Germany, the full analysis set consisted of 1140 GOLD group B – D patients. The total CCQ score decreased from visit 1 to visit 2 with a median absolute change of 0.7 points, “therapeutic success” was achieved in 66.3% of the patients. Regarding the CCQ subdomains the largest improvements were observed in the domains symptoms and functional status both with median absolute decreases of 0.75 points. The general condition of the patients also improved from visit 1 to visit 2. Most of the patients (> 85%) were satisfied or very satisfied with the treatment with Spiolto® Respimat® as well as with inhaling from and handling of the Respimat® device. Nearly all patients (95.2%) at visit 2 declared a willingness to continue the treatment after study end.

    Conclusion: COPD patients treated with Spiolto® Respimat® in routine clinical practice had clinically relevant improvements of their health and functional status (compared to baseline) with the majority being satisfied/very satisfied with the drug treatment and the device itself.


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