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

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:

• tiotropium
• olodaterol
• chronic obstructive pulmonary disease
• COPD
• physical functioning
• non-interventional study

Acknowledgments

This work was supported by Boehringer Ingelheim International GmbH. Medical writing assistance was provided by Martina Stagno d’Alcontres, PhD, CMPP of MediTech Media Ltd., who was contracted and compensated by Boehringer Ingelheim International GmbH. The abstract of this paper was presented at the ERS International Congress, Paris 2018 as a poster presentation with interim findings. The poster’s abstract was published in “Poster Abstracts” in European Respiratory Journal: https://erj.ersjournals.com/content/52/suppl_62/PA912.

Abbreviations

AE, adverse event; FAS, full analysis set; FDC, fixed-dose combination; ICS, inhaled corticosteroid; LABA, long-acting β₂-agonist; LAMA, long-acting muscarinic antagonist; PF-10, 10-question Physical Functioning Questionnaire; PGE, Physician’s Global Evaluation; SF-36, 36-item Short Form Health Survey; SGRQ, St. George’s Respiratory Questionnaire; TS, treated set.

Author contributions

The authors meet criteria for authorship as recommended by the International Committee of Medical Journal Editors. They take full responsibility for the scope, direction, content of, and editorial decisions relating to, the manuscript, were involved at all stages of development, and have approved the submitted manuscript. All authors contributed to data analysis, drafting and revising the article, gave final approval of the version to be published, and agree to be accountable for all aspects of the work.

Disclosure

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.