BACKGROUND: Reduced physical activity is associated with increased morbidity and mortality in patients with COPD. Studies suggest that treatment with the long-acting muscarinic antagonist tiotropium and the long-acting β2-agonist olodaterol increases exercise capacity. This study assessed the effects of a fixed-dose combination (FDC) of tiotropium/olodaterol (delivered via Respimat®) on physical functioning in patients with stable COPD in a "real-world setting". METHODS: An international, open-label, single-arm, non-interventional study conducted in nine countries measuring changes in self-reported physical functioning in COPD patients treated with tiotropium/olodaterol 5/5 μg FDC for approximately 6 weeks. The primary endpoint was therapeutic success, defined as a minimum 10-point increase in the 10-question Physical Functioning Questionnaire (PF-10) score. Secondary endpoints included absolute change in PF-10 from Visit 1 to Visit 2, patient general condition (measured by Physician's Global Evaluation score) and patient satisfaction with the treatment and device (assessed by Patient Satisfaction Questionnaire at the end of the study period). RESULTS: Therapeutic success was observed in 67.8% of 7218 patients (95% CI 66.7, 68.8) in the final analysis set after approximately 6 weeks of treatment with tiotropium/olodaterol. Mean change in PF-10 score between Visit 1 and Visit 2 was 16.6 points (95% CI 16.2, 17.0). Therapeutic success was 64.3% (95% CI 63.0-65.6%) in patients with infrequent (≤1) and 76.1% (95% CI 74.3-77.9%) in patients with frequent (≥2) exacerbations (p<0.0001). Patient general condition improved as indicated by an improvement in Physician's Global Evaluation scores between visits. Most patients were very satisfied or satisfied with tiotropium/olodaterol treatment in general (81%), reported inhalation satisfaction (85%), and satisfactory handling of the device (84%). 1.3% of patients reported an investigator-defined drug-related adverse event. CONCLUSION: Treatment with tiotropium/olodaterol led to an improvement in self-reported physical functioning in patients with COPD.

• Klíčová slova
• COPD, chronic obstructive pulmonary disease, non-interventional study, olodaterol, physical functioning, tiotropium,
• MeSH
• benzoxaziny terapeutické užití   MeSH
• chronická obstrukční plicní nemoc farmakoterapie   patofyziologie   MeSH
• cvičení fyziologie   MeSH
• fixní kombinace léků MeSH
• lidé středního věku MeSH
• lidé MeSH
• senioři MeSH
• tiotropium bromid terapeutické užití   MeSH
• zpráva o sobě * MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• pozorovací studie MeSH
• Geografické názvy
• Evropa MeSH
• Názvy látek
• benzoxaziny MeSH
• fixní kombinace léků MeSH
• tiotropium bromid MeSH
• tiotropium-olodaterol MeSH Prohlížeč

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 β2-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.

• Klíčová slova
• CCQ *, COPD *, Clinical COPD Questionnaire *, non-interventional study *, olodaterol *, tiotropium *,
• MeSH
• agonisté beta-2-adrenergních receptorů škodlivé účinky   MeSH
• antagonisté muskarinových receptorů škodlivé účinky   MeSH
• aplikace inhalační MeSH
• benzoxaziny terapeutické užití   MeSH
• bronchodilatancia škodlivé účinky   MeSH
• chronická obstrukční plicní nemoc * diagnóza   farmakoterapie   MeSH
• fixní kombinace léků MeSH
• lidé MeSH
• průzkumy a dotazníky MeSH
• tiotropium bromid škodlivé účinky   MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• kazuistiky MeSH
• klinické zkoušky MeSH
• Geografické názvy
• Bulharsko MeSH
• Česká republika MeSH
• Izrael MeSH
• Maďarsko MeSH
• Polsko MeSH
• Rumunsko MeSH
• Rusko MeSH
• Švýcarsko MeSH
• Názvy látek
• agonisté beta-2-adrenergních receptorů MeSH
• antagonisté muskarinových receptorů MeSH
• benzoxaziny MeSH
• bronchodilatancia MeSH
• fixní kombinace léků MeSH
• olodaterol MeSH Prohlížeč
• tiotropium bromid MeSH

COPD is a serious pulmonary disease with rising global socioeconomic impact. From the perspective of the Czech Republic COPD was responsible for 21 000 acute hospitalizations and 3 500 deaths, mortality reaches 33/100 000 in 2015. Early stages of disease may be associated with a significant reduction of exercise capacity and the reduction of activities of daily living. Moreover early stages of bronchial obstruction are associated with the fastest lung function decline. Finally, early elimination of the risk of inhalation exposure is able to influence the course of the disease and to reduce its mortality. Most current treatment strategies and national recommendations attributed central role to bronchodilator drugs. Long-acting bronchodilators (LAMA and LABA) creates an essential component of the treatment of symptomatic individuals in the Czech COPD guidelines as well. Actual version of this document constitutes as standard therapy: long-lasting inhaled bronchodilators, targeted efforts to eliminate inhalation risk, vaccination, regular exercise, repeated inhalation technique training, identification, and treatment of relevant comorbidities. All other drugs (inhaled-corticosteroids, mucoactive medication, roflumilast, antibiotics), and non-pharmacological (lung volume reductions, nutrition support, long-term oxygen, home non-invasive ventilation, lung transplantation, palliative care) procedures are intended for a specific subgroups of patients only. The newest type of bronchodilator therapy is represented by a fixed dual bronchodilation. Currently we can use four original drug combinations: titropium + olodaterol, glycopyrronium + indacaterol, umeklidinium + vilanterol and aclidinium + formoterol in the Czech Republic. This area is an enterprising research. For example comprehensive scientific program covering eight studies on 15 000 COPD patients (TOviTO) assess the therapeutic benefits of tiotropium + olodaterolu in terms of lung function, quality of life, exercise tolerance, daily physical activity and the incidence of acute exacerbations. Meanwhile the published results of analyzed studies TONADO, OTEMTO, VIVACITO, and the first results of the study DYNAGITO have showed that fixed dual bronchodilation should be a mandatory treatment to all the symptomatic COPD patients. Unfortunately "face to face" comparison of different drug combinations is still missing. However, the treatment with tiotropium + olodaterol combination has been demonstrated to significantly (35 %) reduce the occurrence of clinically significant deterioration, which may lead to the stabilization of this multicomponent disease.Key words: COPD - hospitalizations - inhaled bronchodilators - mortality - treatment.

• MeSH
• agonisté beta-2-adrenergních receptorů terapeutické užití   MeSH
• antagonisté muskarinových receptorů aplikace a dávkování   MeSH
• aplikace inhalační MeSH
• benzoxaziny terapeutické užití   MeSH
• bronchodilatancia terapeutické užití   MeSH
• chronická obstrukční plicní nemoc farmakoterapie   MeSH
• hormony kůry nadledvin terapeutické užití   MeSH
• kvalita života MeSH
• lidé MeSH
• rozvrh dávkování léků MeSH
• tiotropium bromid terapeutické užití   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• přehledy MeSH
• Geografické názvy
• Česká republika MeSH
• Názvy látek
• agonisté beta-2-adrenergních receptorů MeSH
• antagonisté muskarinových receptorů MeSH
• benzoxaziny MeSH
• bronchodilatancia MeSH
• hormony kůry nadledvin MeSH
• olodaterol MeSH Prohlížeč
• tiotropium bromid MeSH