Therapeutic Success of Tiotropium/Olodaterol, Measured Using the Clinical COPD Questionnaire (CCQ), in Routine Clinical Practice: A Multinational Non-Interventional Study

Abstract

Background The Clinical COPD Questionnaire (CCQ) is a simple patient-reported tool to measure clinical control of chronic obstructive pulmonary disease (COPD). Objective This open-label, single-arm, non-interventional study (NCT03663569) investigated changes in CCQ score during treatment with tiotropium/olodaterol in clinical practice. Methods Data were included from consenting COPD patients, enrolled in Bulgaria, Czech Republic, Hungary, Israel, Lithuania, Poland, Romania, Russia, Slovenia, Switzerland and Ukraine, who were receiving a new prescription for tiotropium/olodaterol according to the treating physician in a real-world environment. The primary endpoint was the occurrence of therapeutic success, defined as a 0.4-point decrease in CCQ score after treatment with tiotropium/olodaterol for approximately 6 weeks. Results Overall, 4819 patients were treated; baseline and Week 6 CCQ scores were available for 4700 patients, mostly classified as Global Initiative for Chronic Obstructive Lung Disease (GOLD) B (51.6%) or D (42.7%). After 6 weeks’ treatment, 81.4% (95% confidence interval [95% CI] 80.24–82.49) of patients achieved therapeutic success; mean improvement in overall CCQ score was 1.02 points (95% CI 1.00–1.05). Improved CCQ score was seen in 92.2% of patients (95% CI 91.43–92.98), 2.5% had no change and 5.3% showed a worsening. When stratified by prior treatment, the greatest benefit was seen in treatment-naïve patients, with 85.7% achieving therapeutic success, compared with 79.5% of those pretreated with long-acting β 2 -agonist (LABA)/inhaled corticosteroid (ICS) and 74.2% of those pretreated with LABA or long-acting muscarinic antagonist (LAMA) monotherapy. Overall, rescue medication decreased by 1.25 puffs/day (95% CI 1.19–1.31) versus baseline. In total, 29 patients (0.6%) reported drug-related adverse events and 7 patients reported serious adverse events (0.15%). Conclusion In 4700 COPD patients, 6 weeks’ treatment with tiotropium/olodaterol, as initial treatment or follow-up to LAMA or LABA monotherapy or LABA/ICS, improved CCQ and decreased rescue medication use. The adverse event profile was consistent with the known safety profile of tiotropium/olodaterol.

An Observational Study Assessing Changes in Health and Functional Status in Patients with Chronic Obstructive Pulmonary Disease (COPD) During Therapy with Spiolto® Respimat® in Everyday Clinical Practice: The Greek ELLACTO Study

“…Indeed, our study extends the previously reported findings by demonstrating that tiotropium/olodaterol Respimat has a beneficial effect not only in patients’ physical functioning (a potential surrogate for health status) but also in the overall health status of patients with COPD. To our knowledge, this study, together with a recent multinational study conducted by Valipour and colleagues [ 22 ] are the first observational studies assessing the effectiveness of tiotropium/olodaterol Respimat in improving the overall health status of COPD, both demonstrating consistent results in terms of clinically meaningful improvements on health status over a similar treatment period [ 22 ].…”

“…The severity of dyspnea was measured via the modified Medical Research Council Dyspnea scale (mMRC). The mMRC is an ordinal four-point scale (grades 0–4) based on degrees of various physical activities that precipitate dyspnea, with grade 4 representing the most severe category [ 22 ]. mMRC together with exacerbation history, and GOLD spirometric classification of airflow limitation (if available) were also used to automatically calculate the GOLD patient group (B, C or D) within the electronic Case Report form (eCRF).…”

Therapeutic Success in Swiss COPD Patients Receiving Dual Bronchodilation Therapy as COPD Maintenance Treatment

“…Clinical studies regarding COPD treatment with the Spiolto Respimat ® inhaler have shown significant improvements in lung function, respiratory symptoms, HRQoL, and exercise capacity [ 15 , 16 , 17 , 18 , 19 ]. In a recently published, real-world, observational study of Valipour et al, treatment with tiotropium–olodaterol via a Spiolto Respimat ® inhaler confirmed those results as an improvement in self-reported HRQoL, as assessed by the Clinical COPD Questionnaire (CCQ) [ 20 ].…”

“…This non-interventional study was an open-label, self-controlled, single-arm, observational study enrolling male and female patients aged ≥40 years with confirmed diagnosis of COPD receiving tiotropium–olodaterol delivered via Spiolto Respimat ® soft mist inhaler. A detailed description of the study design has been published previously by Valipour et al [ 20 ]. Briefly, GOLD patients from group B, C, or D (GOLD COPD Strategy Document 2018) [ 1 ] were consecutively enrolled upon the decision of their treating physician and in accordance with approved summary of product characteristics (SmPC) [ 25 ].…”

“…Up to now, data from COPD patients receiving medical therapy in Swiss clinical practice are limited [ 24 ]. In the current study, we analysed data obtained during the OTIVACTO study of Valipour et al [ 20 ] which focusses on the results of the Swiss patients. Results of the Swiss cohort were compared to the patients from the other participating countries for a better understanding of the clinical outcomes in the subgroup of Swiss COPD patients treated with inhaled tiotropium–olodaterol in comparison to the whole OTIVACTO data.…”