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
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
