PT  - JOURNAL ARTICLE
AU  - Rainard Fuhr
AU  - Soniya Vaidya
AU  - Sanjeev Khindri
AU  - Nicole Calder
AU  - Surendra Machineni
AU  - Salvatore Febbraro
AU  - Ralph Woessner
TI  - Pharmacokinetics (PK) of indacaterol acetate and mometasone furoate delivered alone or in combination following once daily inhalation in healthy subjects
DP  - 2014 Sep 01
TA  - European Respiratory Journal
PG  - P903
VI  - 44
IP  - Suppl 58
4099  - http://erj.ersjournals.com/content/44/Suppl_58/P903.short
4100  - http://erj.ersjournals.com/content/44/Suppl_58/P903.full
SO  - Eur Respir J2014 Sep 01; 44
AB  - QMF149 is an investigational inhaled fixed-dose combination (FDC) of long-acting β2-agonist indacaterol (IND) acetate and corticosteroid mometasone furoate (MF) delivered via the Breezhaler® device for maintenance treatment of asthma and COPD.Objective: To evaluate steady-state plasma PK of MF and IND acetate following once daily inhalation via the Breezhaler® device, either alone or in free or fixed combination.Methods: This randomized, open-label, four-way crossover study recruited 64 healthy subjects to receive IND 150 µg, MF 320 µg, free combination (IND 150 µg + MF 320 µg) or FDC QMF149 150/320μg (IND/MF) once daily for 14 days in each period, with a washout of at least 7 days between periods. PK was characterized on Day 14 up to 168h post-dose.Results: For IND, geometric mean ratios [90% CI] for QMF149 vs. IND alone comparison for AUC0-24h,ss and Cmax,ss were 1.13 [1.09, 1.17] and 1.18 [1.12, 1.25], respectively. For MF, geometric mean ratios [90% CI] for QMF149 vs. MF alone comparison for AUC0-24h,ss and Cmax,ss were 1.14 [1.09, 1.20] and 1.19 [1.13, 1.26], respectively. Similar observations were noted for the FDC vs. free combination comparison. Similar systemic exposure (treatment ratios between 0.99 and 1.11) was noted for the free vs. mono comparison for both analytes, indicating a lack of PK interaction. Multiple inhaled doses of IND and MF, when administered alone, in free or fixed combination were well tolerated.Conclusion: No clinically relevant differences were found in the systemic exposure of IND or MF when administered as QMF149. These data support further development of QMF149 without dose adjustment.