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Journal of Experimental Pharmacology Volume 14, 2022 - Issue
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Commentary

Clinical Interpretation of Efficacy Outcomes in Pharmacological Studies on Triple Fixed-Dose Combination Therapy for Uncontrolled Asthma: Assessment of IRIDIUM and ARGON Studies

Paola Rogliani1 Unit of Respiratory Medicine, Department of Experimental Medicine, University of Rome “Tor Vergata”, Rome, ItalyCorrespondence[email protected]
ORCID Iconhttps://orcid.org/0000-0001-7801-5040
ORCID Icon &
Luigino Calzetta2 Department of Medicine and Surgery, Respiratory Disease and Lung Function Unit, University of Parma, Parma, ItalyORCID Iconhttps://orcid.org/0000-0003-0456-069X
ORCID Icon
Pages 1-5 | Published online: 11 Jan 2022

References

  • Chan KBY, Man-Son-Hing M, Molnar FJ, et al. How well is the clinical importance of study results reported? An assessment of randomized controlled trials. Can Med Assoc J. 2001;165:1197.
  • Jaeschke R, Singer J, Guyatt GH. Measurement of health status: ascertaining the minimal clinically important difference. Control Clin Trials. 1989;10(4):407–415. doi:10.1016/0197-2456(89)90005-6
  • Calzetta L, Ritondo BL, Coppola A, et al. Factors influencing the efficacy of COVID-19 vaccines: a quantitative synthesis of Phase III trials. Vaccines. 2021;9:341. doi:10.3390/vaccines9040341
  • GINA. 2021 GINA main report | Global Initiative for Asthma [Internet]; 2021 [cited July 22, 2021]. Available from: https://ginasthma.org/wp-content/uploads/2021/05/GINA-Main-Report-2021-V2-WMS.pdf. Accessed December 29, 2021.
  • Kerstjens HAM, Maspero J, Chapman KR, 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. Lancet Respir Med. 2020;8:1000–1012. doi:10.1016/S2213-2600(20)30190-9
  • Gessner C, Kornmann O, Maspero J, 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). Respir Med. 2020;170:106021. doi:10.1016/j.rmed.2020.106021
  • NICE. National Institute for Health and Care Excellence (NICE). Inhaled corticosteroid doses for NICE’s asthma guideline; 2018. Available from: www.nice.org.uk/guidance/ng80/resources/inhaled-corticosteroid-doses-pdf-4731528781. Accessed January 16, 2020.
  • Virchow JC. Assessing the benefits of triple versus dual fixed-dose combinations for the treatment of severe asthma. Lancet Respir Med. 2020;8:937–939. doi:10.1016/S2213-2600(20)30303-9
  • Bonini M, Di Paolo M, Bagnasco D, et al. Minimal clinically important difference for asthma endpoints: an expert consensus report. Eur Respir Rev. 2020;29:1–14. doi:10.1183/16000617.0137-2019
  • Parulekar A, Alobaidy A, Hanania N. Asthma outcomes revisited. Curr Opin Pulm Med. 2013;19:6–12. doi:10.1097/MCP.0b013e32835b11f6
  • Pellegrino R, Viegi G, Brusasco V, et al. Interpretative strategies for lung function tests. Eur Respir J. 2005;26:948–968. doi:10.1183/09031936.05.00035205
  • Santanello N, Zhang J, Seidenberg B, et al. What are minimal important changes for asthma measures in a clinical trial? Eur Respir J. 1999;14:23–27. doi:10.1034/j.1399-3003.1999.14a06.x
  • Bateman E. Lack of clinically relevant differences between combination therapy and monotherapy in COPD. Eur Respir J. 2014;43:1204–1205. doi:10.1183/09031936.00156313
  • Validity of outcome measures; 2016 [cited July 20, 2021]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK409867/. Accessed December 29, 2021.
  • Jones PW. St. George’s respiratory questionnaire: MCID. COPD. 2005;2:75–79. doi:10.1081/COPD-200050513
  • Human medicines: highlights of 2020 | European Medicines Agency [Internet]; [cited July 20, 2021]. Available from: https://www.ema.europa.eu/en/news/human-medicines-highlights-2020. Accessed December 29, 2021.
  • Rogliani P, Ritondo BL, Facciolo F, et al. Indacaterol, glycopyrronium, and mometasone: pharmacological interaction and anti-inflammatory profile in hyperresponsive airways. Pharmacol Res. 2021;172:105801. doi:10.1016/j.phrs.2021.105801

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