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

• Published in: International journal of chronic obstructive pulmonary disease Vol. 16; pp. 615 - 628
• Main Authors: Valipour, Arschang, Avdeev, Sergey, Barczyk, Adam, Bayer, Valentina, Fridlender, Zvi, Georgieva, Mariela, Kudela, Ondřej, Medvedchikov, Alexey, Miron, Ramona, Sanzharovskaya, Maria, Šileikienė, Virginija, Šorli, Jurij, Spielmanns, Marc, Szalai, Zsuzsanna
• Format: Journal Article
• Language: English
• Published: New Zealand Dove Medical Press Limited 01.01.2021; Dove Medical Press Ltd; Dove; Dove Medical Press
• Subjects: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists - adverse effects; Benzoxazines - therapeutic use; Bronchodilator Agents - adverse effects; Bulgaria; Care and treatment; ccq; Chronic obstructive pulmonary disease; clinical copd questionnaire; Clinical medicine; Clinical Trial Report; copd; Cost control; Czech Republic; Drug Combinations; Drug dosages; Health aspects; Humans; Hungary; Informed consent; Inhalers; Israel; Lung diseases, Obstructive; Muscarinic Antagonists - adverse effects; non-interventional study; olodaterol; Outdoor air quality; Patient satisfaction; Pharmaceutical industry; Poland; Pulmonary Disease, Chronic Obstructive - diagnosis; Pulmonary Disease, Chronic Obstructive - drug therapy; Quality of life; Questionnaires; Romania; Russia; Success; Surveys; Surveys and Questionnaires; Switzerland; Tiotropium; Tiotropium Bromide - adverse effects; Treatment Outcome; Czech Republic; Romania; Hungary; Poland; Israel; Bulgaria; Switzerland; Russia; Ukraine; United Kingdom; Finland; Slovenia; Lithuania; Germany; CCQ; Clinical COPD Questionnaire; non-interventional study; COPD; olodaterol; tiotropium
• ISSN: 1178-2005; 1176-9106; 1178-2005
• DOI: 10.2147/COPD.S291920

The Clinical COPD Questionnaire (CCQ) is a simple patient-reported tool to measure clinical control of chronic obstructive pulmonary disease (COPD). This open-label, single-arm, non-interventional study (NCT03663569) investigated changes in CCQ score during treatment with tiotropium/olodaterol in clinical practice. 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. 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 -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%). 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.