Mometasone/Indacaterol/Glycopyrronium (MF/IND/GLY) and MF/IND at Different MF Strengths versus Fluticasone Propionate/Salmeterol Xinafoate (FLU/SAL) and FLU/SAL+ Tiotropium in Patients with Asthma

Background Once-daily, single-inhaler mometasone furoate/indacaterol acetate/glycopyrronium bromide (MF/IND/GLY, an ICS/LABA/LAMA) and MF/IND (an ICS/LABA) via Breezhaler® have been approved for the maintenance treatment of patients with asthma inadequately controlled with medium-or high-dose ICS or medium-or high-dose ICS/LABA treatment. Objective Once-daily (o.d.) formulations of MF/IND/GLY and MF/IND at different MF dose strengths have been compared with twice-daily (b.i.d.) fluticasone propionate/salmeterol xinafoate (FLU/SAL), and b.i.d. FLU/SAL+ o.d. tiotropium (TIO) in the PALLADIUM, IRIDIUM and ARGON studies. Methods The similarity in study design and consistent outcomes in these studies prompted the pooling of data in this review to better characterise these novel once-daily controller formulations. Results Pooled data from PALLADIUM and IRIDIUM studies showed comparable or greater efficacy with o.d. MF/IND formulations versus b.i.d. FLU/SAL. The o.d. MF/IND/GLY was superior to b.i.d. FLU/SAL in the IRIDIUM study, and similar to, if not more efficacious than b.i.d. FLU/SAL + o.d. TIO in the ARGON study. Conclusion These formulations therefore provide novel once-daily treatment options for patients across asthma severity and flexibility for clinicians to step-up or step-down the treatment using the same device and formulations.

[1]  Rajesh Venkitakrishnan,et al.  Inhaled steroid - Long acting beta two agonist (ICS-LABA) combinations in asthma: Are all formulations the same? , 2021, The Indian journal of tuberculosis.

[2]  N. Scichilone,et al.  Indacaterol/glycopyrronium/mometasone fixed dose combination for uncontrolled asthma , 2021, Expert review of respiratory medicine.

[3]  D. Hinds,et al.  A systematic literature review of burden of illness in adults with uncontrolled moderate/severe asthma. , 2021, Respiratory medicine.

[4]  H. Kerstjens,et al.  Evaluating contributions of mometasone (MF), indacaterol (IND) and glycopyrronium (GLY) to reduction of exacerbations in patients with inadequately controlled asthma: Results from the IRIDIUM study , 2021, Airway pharmacology and treatment.

[5]  H. Kerstjens,et al.  One time a day mometasone/indacaterol fixed-dose combination versus two times a day fluticasone/salmeterol in patients with inadequately controlled asthma: pooled analysis from PALLADIUM and IRIDIUM studies , 2021, BMJ Open Respiratory Research.

[6]  H. Inoue,et al.  Uncontrolled asthma: a retrospective cohort study in Japanese patients newly prescribed with medium-/high-dose ICS/LABA , 2021, npj Primary Care Respiratory Medicine.

[7]  H. Kerstjens,et al.  Corresponding doses of mometasone furoate (MF) in once-daily inhaled fixed-dose combination (FDC) of indacaterol/mometasone furoate (IND/MF) and indacaterol/glycopyrronium/mometasone furoate (IND/GLY/MF): results from randomized clinical studies , 2021 .

[8]  O. Heudi,et al.  Pharmacokinetics of indacaterol, glycopyrronium and mometasone furoate administered as an inhaled fixed-dose combination in Japanese and Caucasian healthy subjects , 2021, BMC Pulmonary Medicine.

[9]  O. Heudi,et al.  Pharmacokinetics of indacaterol, glycopyrronium and mometasone furoate following once-daily inhalation as a combination in healthy subjects. , 2020, Pulmonary pharmacology & therapeutics.

[10]  I. Pavord,et al.  Efficacy and safety of once-daily single-inhaler triple therapy (FF/UMEC/VI) versus FF/VI in patients with inadequately controlled asthma (CAPTAIN): a double-blind, randomised, phase 3A trial. , 2020, The Lancet. Respiratory medicine.

[11]  C. Gessner,et al.  Fixed-dose combination of indacaterol/glycopyrronium/mometasone furoate once-daily versus salmeterol/fluticasone twice-daily plus tiotropium once-daily in patients with uncontrolled asthma: A randomised, Phase IIIb, non-inferiority study (ARGON). , 2020, Respiratory medicine.

[12]  H. Kerstjens,et al.  Once-daily, single-inhaler mometasone-indacaterol-glycopyrronium versus mometasone-indacaterol or twice-daily fluticasone-salmeterol in patients with inadequately controlled asthma (IRIDIUM): a randomised, double-blind, controlled phase 3 study. , 2020, The Lancet. Respiratory medicine.

[13]  Y. Gon,et al.  Once-daily mometasone plus indacaterol versus mometasone or twice-daily fluticasone plus salmeterol in patients with inadequately controlled asthma (PALLADIUM): a randomised, double-blind, triple-dummy, controlled phase 3 study. , 2020, The Lancet. Respiratory medicine.

[14]  H. Watz,et al.  Letter to the editor: indacaterol/glycopyrronium/mometasone furoate compared with salmeterol/fluticasone propionate in patients with asthma: a randomized controlled cross-over study , 2020, Respiratory Research.

[15]  A. Ismaila,et al.  Impact of Single Combination Inhaler versus Multiple Inhalers to Deliver the Same Medications for Patients with Asthma or COPD: A Systematic Literature Review , 2020, International journal of chronic obstructive pulmonary disease.

[16]  P. D’Andrea,et al.  Efficacy and safety of inhaled once-daily low-dose indacaterol acetate/mometasone furoate in patients with inadequately controlled asthma: Phase III randomised QUARTZ study findings. , 2020, Respiratory medicine.

[17]  J. Virchow,et al.  Single inhaler extrafine triple therapy in uncontrolled asthma (TRIMARAN and TRIGGER): two double-blind, parallel-group, randomised, controlled phase 3 trials , 2019, The Lancet.

[18]  R. Stanford,et al.  Medication adherence in patients with asthma using once-daily versus twice-daily ICS/LABAs , 2019, The Journal of asthma : official journal of the Association for the Care of Asthma.

[19]  M. Adachi,et al.  Prevalence, disease burden, and treatment reality of patients with severe, uncontrolled asthma in Japan. , 2019, Allergology international : official journal of the Japanese Society of Allergology.

[20]  R. D. Dal Negro,et al.  Fluticasone furoate/Vilanterol 92/22 μg once-a-day vs Beclomethasone dipropionate/Formoterol 100/6 μg b.I.D.: a 12-month comparison of outcomes in mild-to-moderate asthma , 2018, Multidisciplinary Respiratory Medicine.

[21]  K. Greive,et al.  Comparative safety and efficacy of topical mometasone furoate with other topical corticosteroids , 2018, The Australasian journal of dermatology.

[22]  F. Güldaval,et al.  Assessment of osteoporosis using the FRAX method and the importance of vitamin D levels in COPD patients , 2018, Multidisciplinary Respiratory Medicine.

[23]  M. Cazzola,et al.  Fixed-Dose Combination Inhalers. , 2016, Handbook of experimental pharmacology.

[24]  H. Nelson,et al.  Effect of once-daily indacaterol maleate/mometasone furoate on exacerbation risk in adolescent and adult asthma: a double-blind randomised controlled trial , 2015, BMJ Open.

[25]  R. Dahl,et al.  Turning a Molecule into a Medicine: the Development of Indacaterol as a Novel Once-Daily Bronchodilator Treatment for Patients with COPD , 2014, Drugs.

[26]  Michael Engel,et al.  Tiotropium in asthma poorly controlled with standard combination therapy. , 2012, The New England journal of medicine.

[27]  S. Keam,et al.  Salmeterol/Fluticasone Propionate , 2012, Drugs.

[28]  R. Leigh,et al.  Mometasone furoate: an inhaled glucocorticoid for the management of asthma in adults and children , 2009, Expert opinion on pharmacotherapy.

[29]  A. van As,et al.  Indacaterol, a novel inhaled β2-agonist, provides sustained 24-h bronchodilation in asthma , 2007, European Respiratory Journal.

[30]  H. Derendorf,et al.  Comparative pharmacology, bioavailability, pharmacokinetics, and pharmacodynamics of inhaled glucocorticosteroids. , 2005, Immunology and allergy clinics of North America.

[31]  H. Nelson,et al.  Enhanced synergy between fluticasone propionate and salmeterol inhaled from a single inhaler versus separate inhalers. , 2003, The Journal of allergy and clinical immunology.

[32]  O. Zetterström,et al.  Improved asthma control with budesonide/formoterol in a single inhaler, compared with budesonide alone. , 2001, The European respiratory journal.

[33]  R. Pauwels,et al.  GLOBAL STRATEGY FOR ASTHMA MANAGEMENT AND PREVENTION , 1996 .