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Clinical Trial
. 2018 Dec 6:13:3923-3936.
doi: 10.2147/COPD.S179293. eCollection 2018.

Indacaterol acetate/mometasone furoate provides sustained improvements in lung function compared with salmeterol xinafoate/fluticasone propionate in patients with moderate-to-very-severe COPD: results from a Phase II randomized, double-blind 12-week study

Kai Michael Beeh  1 , Anne-Marie Kirsten  2 , Ana-Maria Tanase  3 , Alexia Richard  3 , Weihua Cao  4 , Bettina Hederer  3 , Jutta Beier  1 , Oliver Kornmann  5 , Richard N van Zyl-Smit  6
Affiliations
Clinical Trial

Indacaterol acetate/mometasone furoate provides sustained improvements in lung function compared with salmeterol xinafoate/fluticasone propionate in patients with moderate-to-very-severe COPD: results from a Phase II randomized, double-blind 12-week study

Kai Michael Beeh et al. Int J Chron Obstruct Pulmon Dis. .

Abstract

Background and purpose: Fixed-dose combinations of a long-acting beta agonist and an inhaled corticosteroid are more effective than the individual components in COPD. The primary study objective was to demonstrate that the combination indacaterol acetate/mometasone furoate (IND/MF [QMF149]) was non-inferior to the twice-daily combination salmeterol xinafoate/fluticasone propionate (Sal/Flu) in terms of trough FEV1 at week 12 (day 85). Secondary objectives were to compare the efficacy of IND/MF (QMF149) vs Sal/Flu with respect to other lung function parameters, COPD exacerbations, symptoms and dyspnea, health status/health-related quality of life, and rescue medication use.

Materials and methods: This was a 12-week multicenter, randomized, double-blind, double-dummy, parallel-group, Phase II study in patients with moderate-to-very-severe COPD, who were randomized (1:1) to IND/MF (QMF149) (150/160 µg once daily; n=316) or Sal/Flu (50/500 µg twice daily; n=313).

Results: Over 90% of patients completed the study: 94.6% in the IND/MF (QMF149) group and 92.0% in the Sal/Flu group. The primary objective of non-inferiority of IND/MF (QMF149) to Sal/Flu for trough FEV1 at week 12 (day 85) was met: the lower limit of the CI (95% CI: 27.7, 83.3 mL) was greater than -60 mL. The analysis for superiority of IND/MF (QMF149) to Sal/Flu demonstrated superiority of IND/MF (QMF149), with a difference of 56 mL (P<0.001). In addition, IND/MF (QMF149) treatment significantly improved COPD exacerbation-related parameters during the 12-week period. Other significant improvements with IND/MF (QMF 149) vs Sal/Flu were noted for dyspnea at week 12 and other COPD symptoms and COPD rescue medication use over the 12 weeks. The safety and tolerability profiles of both the treatments were similar.

Conclusion: IND/MF (QMF149) (150/160 µg once daily) offered superior lung function and symptom efficacy and a favorable safety profile compared with Sal/Flu (50/500 µg twice daily) in patients with moderate-to-very severe COPD.

Keywords: COPD; LABA/ICS combinations; fixed-combination inhalers; indacaterol; mometasone; once-daily inhalers.

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Conflict of interest statement

Disclosure AMT, BH and AR are employees of Novartis Pharma AG. WC is an employee of Novartis Pharmaceuticals Corporation. KMB declares that no personal payments were received from any pharmaceutical entity in the past 5 years. KMB and JB are full-time employees of Insaf Respiratory Research Institute. AMK is an employee of the Pulmonary Research Institute at LungClinic Grosshansdorf. AMK received speaking honoraria, honoraria for participation in advisory board meetings, and travel support for attending congresses in respiratory medicine from Boehringer Ingelheim, AstraZeneca, and Novartis. RNVZS has received honoraria for academic work from Novartis, AZ, CIPLA, ASPEN, Pfizer, GSK, and MSD. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
Study design. Notes: Throughout the run-in phase, all patients received a LABA bid and SAMA (ipratropium) qid. At the start of the run-in period, patients were required to discontinue any previous ICS medication and qd bronchodilators (LABA and LAMA; patients receiving these treatments had to be switched at the screening visit to LABA bid or SAMA qid, respectively). Indacaterol (LABA qd) had to be switched at the screening visit to LABA bid. A minimum of a 48-hour washout period for LABA bid and 8 hours for SAMA prior to the spirometry assessment at the run-in and randomization visits were maintained. Patients were contacted for safety evaluations during the 30 days following the last study visit or following the last administration of study treatment if there were post-treatment follow-up visits (whichever was later), including a final contact at the 30-day point. Abbreviations: qd, once-daily; bid, twice-daily; qid, four times daily; LABA, long-acting beta agonist; LAMA, long-acting muscarinic antagonist; SAMA, short-acting muscarinic antagonist; IND/MF, indacaterol acetate/mometasone furoate; Sal/Flu, salmeterol xinafoate/fluticasone propionate.
Figure 2
Figure 2
Summary of patient disposition. Abbreviations: IND/MF, indacaterol acetate/mometasone furoate; Sal/Flu, salmeterol xinafoate/fluticasone propionate.
Figure 3
Figure 3
Absolute value of trough FEV1 over 12 weeks of treatment (FAS). Abbreviations: FAS, full analysis set; IND/MF, indacaterol acetate/mometasone furoate; LS, least squares; Sal/Flu, salmeterol xinafoate/fluticasone propionate.
Figure 4
Figure 4
Four-hour profile of FEV1 on day 1 of treatment, from 5 minutes to 4 hours post-dose (FAS). Abbreviations: FAS, full analysis set; IND/MF, indacaterol acetate/mometasone furoate; LS, least squares; Sal/Flu, salmeterol xinafoate/fluticasone propionate.
Figure 5
Figure 5
Time to first moderate or severe COPD exacerbation (FAS). Abbreviations: FAS, full analysis set; IND/MF, indacaterol acetate/mometasone furoate; Sal/Flu, salmeterol xinafoate/fluticasone propionate.
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