Source: International Congress 2015 – New data on established treatments for asthma, COPD and bronchiectasis
Disease area: Airway diseases

Abstract

Background: As part of the development program for an inhaled triple combination (CHF 5993 pMDI) as a twice-daily therapy for the treatment of COPD and asthma, with extrafine inhaled corticosteroid, Glycopyrronium bromide (GB), and Formoterol Fumarate (FF), this study investigated the pharmacokinetic (PK) interaction between GB and formoterol, the bronchodilator components of the combination.Methods: This was a randomized, open-label, placebo controlled, single-dose, 4-way cross-over study in healthy volunteers. They received a single dose of GB (total dose 100 mg) and FF (total dose 24 mg, Atimos^®) as free combination (Test) or as single components (References).Results: 44 subjects, mean age (range) 42.3 years (20-65), 39% males, were randomised.GB had no impact on Formoterol exposure since the 90% CI of the geometric mean ratio for Formoterol C_max and AUC_t were within the equivalence interval of 80-125%.Similarly, the 90% CI for GB AUC_t was within the pre-defined range. Higher maximum GB exposure (Cmax P.E. 119%, 90% CI 105%-134%) was observed after administration of the free combination in comparison with GB alone. However the higher exposure to GB immediately after inhalation was transient as indicated by the AUC_0-30min confidence intervals which were within the 80-125% equivalence limits. In addition comparable cardiovascular profiles between treatments were observed.Conclusion: Study results supported the absence of clinically relevant pharmacokinetic interactions between extrafine GB and FF. The administered treatments were safe and well tolerated.


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Fabrizia Mariotti (Parma, Italy), Sara Collarini, Anna Compagnoni, Dario Cuomo, Fabrizia Mariotti, Annamaria Muraro, Daniela Acerbi. Pharmacokinetic interaction of glycopyrronium bromide pMDI and formoterol pMDI: A randomized, open-label, single-dose, 4-way cross-over study. Eur Respir J 2015; 46: Suppl. 59, 2961

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