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

Abstract

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.

EVELUT®: A Real-World, Observational Study Assessing Dyspnoea and Symptom Burden in COPD Patients Switched from LABA/ICS to LAMA/LABA or LAMA/LABA/ICS

“…The EVELUT study builds upon this evidence base by providing data from a longer follow-up period (~ 12 weeks). High levels of patient satisfaction with the inhaler device and with treatment overall were reported in both arms after 12 weeks, consistent with previous non-interventional studies reporting patient-reported outcomes for Tio/Olo [ 12 , 13 , 15 , 16 ]. Patients using ≥ 2 products for TT had the highest levels of satisfaction, suggesting that, contrary to previous studies [ 17 , 18 ], patients may not necessarily prefer to use a single device and may prefer to use devices that they are familiar with to manage their COPD.…”

“…Regarding safety, the ADRs reported in the Tio/Olo arm were mostly in line with the known safety profile, as listed in the Summary of Product Characteristics for Spiolto Respimat [ 19 ]. The percentage of ADRs in the Tio/Olo arm was slightly higher than in other non-interventional studies of Tio/Olo, in which ~ 1% of patients typically report ADRs [ 12 , 13 , 20 ], but was lower than in clinical trials (~ 6% treatment-related adverse events) [ 21 , 22 ].…”

Monthly Follow-Ups of Functional Status in People with COPD: A Longitudinal Study

“…Moreover, a causal relationship could not be established, since we could not control for all possible factors explaining this improvement. For instance, it was not possible to study in detail the physical activity levels, type of comorbidities, and medication, which might have potential effects in functional status [ 4 , 48 ]. Therefore, more research is needed to corroborate our findings and establish an adequate frequency for clinical monitoring of people with COPD [ 49 ].…”