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Observational Study
. 2019 Oct 11:14:2343-2354.
doi: 10.2147/COPD.S204388. eCollection 2019.

Improvement In Self-Reported Physical Functioning With Tiotropium/Olodaterol In Central And Eastern European COPD Patients

Arschang Valipour  1 , Michael Tamm  2 , Jana Kociánová  3 , Valentina Bayer  4 , Maria Sanzharovskaya  5 , Alexey Medvedchikov  6 , Monika Haaksma-Herczegh  6 , János Mucsi  7 , Zvi Fridlender  8 , Claudia Toma  9   10 , Andrey Belevskiy  11 , Bohumil Matula  12 , Jurij Šorli  13
Affiliations
Observational Study

Improvement In Self-Reported Physical Functioning With Tiotropium/Olodaterol In Central And Eastern European COPD Patients

Arschang Valipour et al. Int J Chron Obstruct Pulmon Dis. .

Abstract

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.

Keywords: COPD; chronic obstructive pulmonary disease; non-interventional study; olodaterol; physical functioning; tiotropium.

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Conflict of interest statement

Dr Arschang Valipour reports personal fees, non-financial support from Boehringer Ingelheim, personal fees from Novartis, Chiesi, and AstraZeneca, during the conduct of the study. Dr Valentina Bayer, Dr Maria Sanzharovskaya, Dr Alexey Medvedchikov are employees of Boehringer Ingelheim. Prof. Dr Zvi Fridlender reports personal fees and institutional support from Boehringer Ingelheim, during the conduct of the study. Prof Dr. Zvi Fridlender also reports personal fees from GSK, Novartis, AstraZeneca, Boehringer Ingelheim, Teva, and Rafa, outside the submitted work. Dr Claudia Toma reports grants, personal fees from Boehringer Ingelheim, during the conduct of the study, personal fees, non-financial support from AstraZeneca, Berlin Chemie, Boehringer Ingelheim, Novartis, Roche, Sandoz and Chiesi, personal fees from Amring, Bayer Pharma, Cipla, and Bristol Myers Squibb, and non-financial support from Actelion, Angelini, and Terapia, from outside the submitted work. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
Patient flow chart. Abbreviations: FAS, full analysis set; PF-10, 10-question Physical Functioning Questionnaire; TS, treated set.
Figure 2
Figure 2
General patient condition: Physician’s Global Evaluation score.
Figure 3
Figure 3
Patient overall satisfaction with treatment.
See this image and copyright information in PMC

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