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Randomized Controlled Trial
. 2017 Dec 22:13:69-77.
doi: 10.2147/COPD.S146189. eCollection 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

Peter Kardos  1 , Ina Hagedorn-Peinz  2
Affiliations
Randomized Controlled Trial

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

Peter Kardos et al. Int J Chron Obstruct Pulmon Dis. .

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; FEV1; dual bronchodilators; indacaterol/glycopyrronium; treatment choice; treatment preference.

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Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Study design. Notes: During screening, patients received their current COPD treatment and were instructed to abstain from tiotropium inhalation on visit 3 (randomization). Inhaled corticosteroids were allowed to be taken throughout the study when started 30 days prior to screening visit. Abbreviations: IND/GLY, indacaterol/glycopyrronium; o.d., once daily; V, visit.
Figure 2
Figure 2
Patient disposition (full analysis set). Notes: aForty-three patients were randomized into the sequence 1 (IND/GLY – tiotropium) and 45 patients were randomized into sequence 2 (tiotropium – IND/GLY). Three patients randomized to the IND/GLY – tiotropium group were treated vice-versa (ie, tiotropium – IND/GLY). bOne patient discontinued due to adverse event in tiotropium – IND/GLY group after start of treatment period 2. Abbreviation: IND/GLY, indacaterol/glycopyrronium.
Figure 3
Figure 3
FEV1 (L) 1 h post-inhalation after 4 weeks of each treatment (full analysis set). Note: Data are least square means ±95% CI. Abbreviations: FEV1, forced expiratory volume in 1 s; IND/GLY, indacaterol/glycopyrronium.
Figure 4
Figure 4
Very important/important subjective reasons cited by patients and physicians for a preference for IND/GLY or tiotropium (full analysis set). Notes: Data are displayed as percentage of patients/physicians that rated the provided reasons from a 5-item scale (very important, important, neutral, unimportant, and very unimportant) as very important or important. Two patients and 1 physician did not answer the questionnaire. Abbreviation: IND/GLY, indacaterol/glycopyrronium.
Figure 5
Figure 5
Patients very satisfied/satisfied with their treatment (full analysis set). Notes: Data are displayed as percentage of patients that were very satisfied or satisfied with the medication in terms of the provided items. All patients answered the questionnaire with exception of 1 patient who discontinued the study. Abbreviation: IND/GLY, indacaterol/glycopyrronium.
Figure 6
Figure 6
TSQM-9 questionnaire results by domain (full analysis set). Notes: Data are least square mean (±95% CI) of TSQM-9 total scores by domain (effectiveness, convenience, and global satisfaction) determined after 4 weeks of treatment. *p=0.0001, **p=0.0035. All patients answered the questionnaire with exception of 1 patient who discontinued the study. Abbreviations: IND/GLY, indacaterol/glycopyrronium; TSQM-9, Treatment Satisfaction Questionnaire for Medication.
Figure 7
Figure 7
Improvement in FEV1 (L) 1 h post-inhalation based on medication preference (full analysis set). Note: Data are in least square mean ±95% CI. Abbreviations: FEV1, forced expiratory volume in 1 s; IND/GLY, indacaterol/glycopyrronium.
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