The impact of indacaterol/glycopyrronium fixed-dose combination versus tiotropium monotherapy on lung function and treatment preference: a randomized crossover study – the FAVOR study

Abstract

Background

The objective of the FAVOR study was to evaluate the effect of indacaterol/glycopyrronium (IND/GLY) versus tiotropium on peak forced expiratory volume in 1 s (FEV₁) and also to investigate patient satisfaction and treatment preference.

Methods

Patients with moderate-to-severe airflow limitation (FEV₁/forced vital capacity ratio of <0.70), those with a COPD assessment test score of ≥10, and those who were maintained on tiotropium HandiHaler^® therapy prior to enrollment were recruited for the study, and randomized (1:1) to receive either 4 weeks open-label IND/GLY (110/50 μg) once daily followed by 4 weeks of tiotropium (18 μg) once daily or vice versa. The primary endpoint was FEV₁ 1 h post-inhalation after 4 weeks of treatment. Other endpoints included patient’s and physician’s preference for treatment, patient’s satisfaction evaluated using a study-specific questionnaire and the abbreviated Treatment Satisfaction Questionnaire for Medication, and safety and tolerability.

Results

Eighty-seven out of 88 randomized patients completed the study and showed significantly higher FEV₁ 1 h post-inhalation after 4 weeks of treatment with IND/GLY versus tiotropium (treatment difference =0.081 L; p=0.0017). IND/GLY was preferred over tiotropium among the patients (69.4% versus 30.6%, p=0.0004) and the physicians (81.6% versus 18.4%, p<0.0001). A higher proportion of the patients stated they were very satisfied or satisfied with IND/GLY versus tiotropium with regard to dyspnea reduction (79.3% versus 58.0%, respectively) and reduction of dyspnea on exertion (72.4% versus 43.2%, respectively). Patients treated with IND/GLY showed significant improvement in Treatment Satisfaction Questionnaire for Medication domain scores versus tiotropium. IND/GLY demonstrated a good safety and tolerability profile.

Conclusion

This study indicated that, beyond FEV₁, important patient-reported outcomes improved with the open-label dual bronchodilator IND/GLY when compared with tiotropium. This study suggests that individual patients felt the lung function benefits with IND/GLY compared with tiotropium, which, in turn, may also have contributed to the preference for IND/GLY.

Keywords:

• COPD
• dual bronchodilators
• FEV₁
• indacaterol/glycopyrronium
• treatment preference
• treatment choice

Acknowledgments

The authors thank patients and investigators who participated in the study. They also thank Ananya Chikramane, PhD, and David Bergin, PhD (professional medical writers; Novartis) for assistance in the preparation of this paper. Writing support was funded by Novartis Pharma GmbH, Germany. This study was funded and supported by Novartis Pharma GmbH, Germany.

Disclosure

Dr Peter Kardos reports personal fees and study honoraria for his practice from Novartis during the conduct of the study; personal fees and other from AstraZeneca and Boehringer Ingelheim; and personal fees from Chiesi, GSK, Menarini, and Teva, outside the submitted work. Dr Ina Hagedorn-Peinz is an employee of Novartis Pharma GmbH and was in a medical role during the study conduct and in a commercial role during the manuscript development. The authors report no other conflicts of interest in this work.