Improvement In Self-Reported Physical Functioning With Tiotropium/Olodaterol In Central And Eastern European COPD Patients.
- Valipour A Department of Respiratory and Critical Care Medicine, Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology, Krankenhaus Nord - Klinik Floridsdorf, Vienna, Austria.
- Tamm M Lung Centre/Pneumology Department, University Hospital Basel, Basel, Switzerland.
- Kociánová J Pneumological Outpatient Department, MephaCentrum, a.s., Ostrava-Poruba, Czech Republic.
- Bayer V Biostatistics and Data Sciences, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.
- Sanzharovskaya M Respiratory TA, Boehringer Ingelheim RCV GmbH & Co. KG, Vienna, Austria.
- Medvedchikov A Medical Affairs Regional Center, Boehringer Ingelheim RCV GmbH & Co. KG, Vienna, Austria.
- Haaksma-Herczegh M Medical Affairs Regional Center, Boehringer Ingelheim RCV GmbH & Co. KG, Vienna, Austria.
- Mucsi J Elizabeth Nursing Home, Gödöllő, Hungary.
- Fridlender Z Department of Internal Medicine, Hebrew University Hadassah Medical School, Jerusalem, Israel.
- Toma C Department of Pneumology, Institute of Pneumatology "Marius Nasta", Bucharest, Romania.
- Belevskiy A Department of Pulmonology, Pirogov Russian National Research Medical University, Pletnev Hospital, Moscow, Russian Federation.
- Matula B Department of Functional Diagnostics, Specialized Hospital of Saint Zoerardus, Teaching Facility of the Slovak Medical University, Nitra, Slovakia.
- Šorli J Topolšica Hospital, Topolšica, Slovenia.
- 2019-10-22
Published in:
- International journal of chronic obstructive pulmonary disease. - 2019
COPD
chronic obstructive pulmonary disease
non-interventional study
olodaterol
physical functioning
tiotropium
Aged
Benzoxazines
Drug Combinations
Europe
Exercise
Female
Humans
Male
Middle Aged
Pulmonary Disease, Chronic Obstructive
Self Report
Tiotropium Bromide
English
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.
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.
- Language
-
- English
- Open access status
- gold
- Identifiers
-
- DOI 10.2147/COPD.S204388
- PMID 31632003
- Persistent URL
- https://sonar.ch/global/documents/73308
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