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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.

Authors+Show Affiliations

Pulmonary Department, Respiratory and Sleep Medicine at Red Cross Maingau Hospital, Group Practice Allergy, Frankfurt, Germany.Novartis Pharma GmbH, Nuremberg, Germany.

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

29317812

Citation

Kardos, Peter, and Ina Hagedorn-Peinz. "The Impact of Indacaterol/glycopyrronium Fixed-dose Combination Versus Tiotropium Monotherapy On Lung Function and Treatment Preference: a Randomized Crossover Study - the FAVOR Study." International Journal of Chronic Obstructive Pulmonary Disease, vol. 13, 2018, pp. 69-77.
Kardos P, Hagedorn-Peinz I. The impact of indacaterol/glycopyrronium fixed-dose combination versus tiotropium monotherapy on lung function and treatment preference: a randomized crossover study - the FAVOR study. Int J Chron Obstruct Pulmon Dis. 2018;13:69-77.
Kardos, P., & Hagedorn-Peinz, I. (2018). The impact of indacaterol/glycopyrronium fixed-dose combination versus tiotropium monotherapy on lung function and treatment preference: a randomized crossover study - the FAVOR study. International Journal of Chronic Obstructive Pulmonary Disease, 13, 69-77. https://doi.org/10.2147/COPD.S146189
Kardos P, Hagedorn-Peinz I. The Impact of Indacaterol/glycopyrronium Fixed-dose Combination Versus Tiotropium Monotherapy On Lung Function and Treatment Preference: a Randomized Crossover Study - the FAVOR Study. Int J Chron Obstruct Pulmon Dis. 2018;13:69-77. PubMed PMID: 29317812.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The impact of indacaterol/glycopyrronium fixed-dose combination versus tiotropium monotherapy on lung function and treatment preference: a randomized crossover study - the FAVOR study. AU - Kardos,Peter, AU - Hagedorn-Peinz,Ina, Y1 - 2017/12/22/ PY - 2018/1/11/entrez PY - 2018/1/11/pubmed PY - 2018/9/18/medline KW - COPD KW - FEV1 KW - dual bronchodilators KW - indacaterol/glycopyrronium KW - treatment choice KW - treatment preference SP - 69 EP - 77 JF - International journal of chronic obstructive pulmonary disease JO - Int J Chron Obstruct Pulmon Dis VL - 13 N2 - 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. SN - 1178-2005 UR - https://www.unboundmedicine.com/medline/citation/29317812/The_impact_of_indacaterol/glycopyrronium_fixed_dose_combination_versus_tiotropium_monotherapy_on_lung_function_and_treatment_preference:_a_randomized_crossover_study___the_FAVOR_study_ L2 - https://dx.doi.org/10.2147/COPD.S146189 DB - PRIME DP - Unbound Medicine ER -