Health and functional status of tiotropium/olodaterol-treated patients with COPD: results from the AERIAL® non-interventional study

Abstract

Patients with 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® (ClinicalTrials.gov NCT03165045) was a German, non-interventional study of patients with COPD receiving treatment with tiotropium/olodaterol under real-world conditions for ∼6 weeks. The primary end-point 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 was used to assess the patients' general condition. Safety was assessed, as well as patient satisfaction and willingness to continue treatment. Out of 1351 screened patients, 1322 were treated and 1140 comprised the full analysis set. The primary end-point was met: 66.3% of patients achieved a ≥0.4-point decrease in overall CCQ score (mean±sd decrease 0.78±0.95). Mean±sd decreases 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. >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.

Conflict of interest statement

Conflict of interest: A. Gillissen reports nonfinancial support from Boehringer Ingelheim during the conduct of the study. Conflict of interest: A. Marseille is an employee of Boehringer Ingelheim. Conflict of interest: D. Skowasch reports personal fees from Boehringer Ingelheim, AstraZeneca, Berlin-Chemie, GSK, Grifols and Novartis, outside the submitted work. Conflict of interest: J. Ritz is an employee of Boehringer Ingelheim. Conflict of interest: M. Mattiucci-Guehlke is an employee of Boehringer Ingelheim. Conflict of interest: S. Pabst has nothing to disclose. Conflict of interest: T. Greulich reports personal fees from AstraZeneca, Berlin-Chemie, Boehringer Ingelheim, GSK, Novartis, Roche and Chiesi, and grants and personal fees from CSL Behring and Grifols, outside the submitted work. Conflict of interest: R. Koczulla has nothing to disclose.

Copyright ©The authors 2021.

Figures

FIGURE 1

Patient disposition. Of the nine patients who were not registered, the reasons were violation of inclusion criterion 2 (n=2), allocation to Global Initiative for Chronic Obstructive Lung Disease COPD group A (n=3), meeting an exclusion criterion (unspecified, n=1), ongoing combined long-acting β2-agonist (LABA) + inhaled corticosteroid therapy (n=1) or LABA/long-acting muscarinic antagonist therapy (n=2). There were no protocol violations due to informed consent. CCQ: Clinical COPD Questionnaire.

FIGURE 2

Proportion of patients achieving therapeutic success at visit 2. Therapeutic success was defined as a 0.4-point decrease in Clinical COPD Questionnaire score between visit 1 and visit 2. LABA: long-acting β2-agonist; LAMA: long-acting muscarinic antagonist; ICS: inhaled corticosteroid; GOLD: Global Initiative for Chronic Obstructive Lung Disease.

FIGURE 3

Absolute change in Clinical COPD Questionnaire (CCQ) score from visit 1 to visit 2. Data are presented as mean±sd.

FIGURE 4

Patients’ general condition (Physician's Global Evaluation (PGE) score) at visits 1 and 2. PGE score 1–2=poor, 3–4=satisfactory, 5–6=good, 7–8=excellent.

FIGURE 5

Patient satisfaction with tiotropium/olodaterol treatment overall, and in terms of inhaling from, and handling of the device at visit 2. Visit 2 was ∼6 weeks after visit 1 (baseline).