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Efficacy of once-daily, single-inhaler, fixed-dose combination of mometasone/indacaterol/glycopyrronium in patients with asthma with or without persistent airflow limitation: Post hoc analysis from the IRIDIUM study.
Van Zyl-Smit, Richard N; Kerstjens, Huib Am; Maspero, Jorge F; Kostikas, Konstantinos; Hosoe, Motoi; Tanase, Ana-Maria; D'Andrea, Peter; Mezzi, Karen; Brittain, Dominic; Lawrence, David; Chapman, Kenneth R.
Afiliación
  • Van Zyl-Smit RN; Division of Pulmonology and UCT Lung Institute, Department of Medicine, University of Cape Town, Cape Town, South Africa. Electronic address: richard.vanzyl-smit@uct.ac.za.
  • Kerstjens HA; Department of Pulmonology, University of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD, Groningen, the Netherlands.
  • Maspero JF; Allergy and Respiratory Research Unit, Fundación Centro Investigacion de Enfermedades Alergicas y Respiratorias, Buenos Aires, Argentina.
  • Kostikas K; Respiratory Medicine Department, University of Ioannina, Ioannina, Greece.
  • Hosoe M; Novartis Pharma AG, Basel, Switzerland.
  • Tanase AM; Novartis Pharma AG, Basel, Switzerland.
  • D'Andrea P; Novartis Pharmaceuticals Corporation, East Hanover, USA.
  • Mezzi K; Novartis Pharma AG, Basel, Switzerland.
  • Brittain D; Novartis Pharma AG, Basel, Switzerland.
  • Lawrence D; Novartis Pharma AG, Basel, Switzerland.
  • Chapman KR; Division of Respiratory Medicine, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
Respir Med ; 211: 107172, 2023 05.
Article en En | MEDLINE | ID: mdl-36906187
BACKGROUND: A novel, once-daily, fixed-dose combination of mometasone furoate/indacaterol acetate/glycopyrronium bromide (MF/IND/GLY) delivered via Breezhaler® is the first inhaled corticosteroid/long-acting ꞵ2-agonist/long-acting muscarinic antagonist (ICS/LABA/LAMA) therapy approved for the maintenance treatment of asthma in adults inadequately controlled on ICS/LABA combination. In patients with asthma and persistent airflow limitation (PAL), maximal treatment, especially with combination is suggested. This post hoc analysis of data from the IRIDIUM study assessed the efficacy of MF/IND/GLY in asthma patients with and without PAL. METHODS: Patients with post-bronchodilator FEV1 ≤80% of predicted and FEV1/FVC ratio of ≤0.7 were categorised as PAL subgroup and the remaining as the non-PAL subgroup. Lung function parameters (FEV1, PEF, and FEF25%-75%) and annualised asthma exacerbations rates were evaluated in both subgroups across the treatment arms: once-daily high-dose MF/IND/GLY (160/150/50 µg), high-dose MF/IND (320/150 µg) and twice-daily high-dose fluticasone/salmeterol (FLU/SAL; 500/50 µg). RESULTS: Of the 3092 randomised patients, 64% (n = 1981) met the criteria for PAL. Overall, there was no evidence of treatment difference between PAL and non-PAL subgroups (interaction P-value for FEV1, FEF25%-75%, PEF, moderate or severe exacerbations, severe exacerbations and all exacerbations were 0.42, 0.08, 0.43 0.29, 0.35 and 0.12, respectively). In the PAL subgroup, high-dose MF/IND/GLY versus high-dose MF/IND and high-dose FLU/SAL improved trough FEV1 (mean difference: 102 mL [P < 0.0001] and 137 mL [P < 0.0001]) and reduced moderate or severe (16% and 32%), severe (25% and 39%) and all exacerbations (19% and 38%), respectively. CONCLUSIONS: Once-daily fixed-dose MF/IND/GLY was efficacious in asthma patients with and without persistent airflow limitation.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Asma / Enfermedad Pulmonar Obstructiva Crónica Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Adult / Humans Idioma: En Revista: Respir Med Año: 2023 Tipo del documento: Article Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Asma / Enfermedad Pulmonar Obstructiva Crónica Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Adult / Humans Idioma: En Revista: Respir Med Año: 2023 Tipo del documento: Article Pais de publicación: Reino Unido