Triple Therapy with Mometasone/Indacaterol/Glycopyrronium or Doubling the ICS/LABA Dose in GINA Step 4: IRIDIUM Analyses
| dc.contributor.author | van Zyl-Smit, Richard N. | |
| dc.contributor.author | Kerstjens, Huib A. M. | |
| dc.contributor.author | Maspero, Jorge | |
| dc.contributor.author | Tanase, Ana-Maria | |
| dc.contributor.author | Lawrence, David | |
| dc.contributor.author | Mezzi, Karen | |
| dc.contributor.author | D’Andrea, Peter | |
| dc.contributor.author | Chapman, Kenneth R. | |
| dc.date.accessioned | 2023-08-08T06:48:48Z | |
| dc.date.available | 2023-08-08T06:48:48Z | |
| dc.date.issued | 2023-08-01 | |
| dc.date.updated | 2023-08-06T03:14:16Z | |
| dc.description.abstract | Abstract Introduction GINA guidelines recommend increasing the dose of inhaled corticosteroids (ICS) as a step-up option for patients with inadequately controlled asthma at GINA step 4 [inadequately controlled asthma on medium-dose ICS/long-acting beta-2 agonist (LABA)]. The aim of this study was to compare the efficacy and safety of long-acting muscarinic antagonists (LAMA) add-on to medium-dose ICS/LABA in patients at GINA 2022 step 4. Methods This post hoc analysis of the IRIDIUM study evaluated the change from baseline in trough forced expiratory volume (FEV1 ) in patients receiving medium-dose MF/IND/GLY versus high-dose MF/IND and high-dose FLU/SAL at Week 26. Other outcomes included improvement in lung functions [peak expiratory flow (PEF), forced vital capacity (FVC), forced expiratory flow between 25% and 75% of the FVC (FEF)25–75%)], asthma control [Asthma Control Questionnaire (ACQ-7)], responder analysis (≥ 0.5 unit improvement in ACQ-7), and reduction in asthma exacerbations at Weeks 26 and 52. Results A total of 1930 patients were included in this analysis. Medium-dose MF/IND/GLY improved trough FEV1 versus high-dose MF/IND (Δ 41 mL; 95% CI – 7–90) and high-dose FLU/SAL (Δ 88 mL; 95% CI 39–137) at Week 26 which were sustained until Week 52. Exacerbation rates were 16% lower with medium-dose MF/IND/GLY versus high-dose MF/IND for all (mild, moderate, and severe) exacerbations and 21–30% lower versus high-dose FLU/SAL for all (mild, moderate, and severe), moderate or severe, and severe exacerbations over 52 weeks. Further improvements in other lung functions were observed with medium-dose MF/IND/GLY. No new safety signals were identified. Conclusion Medium-dose MF/IND/GLY improved lung function and reduced asthma exacerbations compared to high-dose ICS/LABA and may be an undervalued option in patients at GINA 2022 step 4. Trial Registration ClinicalTrials.gov Identifier: NCT02571777. | |
| dc.identifier.apacitation | van Zyl-Smit, Richard N., Kerstjens, Huib A. M., Maspero, J., Tanase, A., Lawrence, D., Mezzi, K., ... Chapman, Kenneth R. (2023). Triple Therapy with Mometasone/Indacaterol/Glycopyrronium or Doubling the ICS/LABA Dose in GINA Step 4: IRIDIUM Analyses. http://hdl.handle.net/11427/38211 | en_ZA |
| dc.identifier.chicagocitation | van Zyl-Smit, Richard N., Huib A. M. Kerstjens, Jorge Maspero, Ana-Maria Tanase, David Lawrence, Karen Mezzi, , and Kenneth R. Chapman "Triple Therapy with Mometasone/Indacaterol/Glycopyrronium or Doubling the ICS/LABA Dose in GINA Step 4: IRIDIUM Analyses." (2023) http://hdl.handle.net/11427/38211 | en_ZA |
| dc.identifier.citation | van Zyl-Smit, Richard N., Kerstjens, Huib A. M., Maspero, J., Tanase, A., Lawrence, D., Mezzi, K., & Chapman, Kenneth R. et al. 2023. Triple Therapy with Mometasone/Indacaterol/Glycopyrronium or Doubling the ICS/LABA Dose in GINA Step 4: IRIDIUM Analyses. http://hdl.handle.net/11427/38211 | en_ZA |
| dc.identifier.ris | TY - Journal Article AU - van Zyl-Smit, Richard N. AU - Kerstjens, Huib A. M. AU - Maspero, Jorge AU - Tanase, Ana-Maria AU - Lawrence, David AU - Mezzi, Karen AU - D’Andrea, Peter AU - Chapman, Kenneth R. AB - Abstract Introduction GINA guidelines recommend increasing the dose of inhaled corticosteroids (ICS) as a step-up option for patients with inadequately controlled asthma at GINA step 4 [inadequately controlled asthma on medium-dose ICS/long-acting beta-2 agonist (LABA)]. The aim of this study was to compare the efficacy and safety of long-acting muscarinic antagonists (LAMA) add-on to medium-dose ICS/LABA in patients at GINA 2022 step 4. Methods This post hoc analysis of the IRIDIUM study evaluated the change from baseline in trough forced expiratory volume (FEV1 ) in patients receiving medium-dose MF/IND/GLY versus high-dose MF/IND and high-dose FLU/SAL at Week 26. Other outcomes included improvement in lung functions [peak expiratory flow (PEF), forced vital capacity (FVC), forced expiratory flow between 25% and 75% of the FVC (FEF)25–75%)], asthma control [Asthma Control Questionnaire (ACQ-7)], responder analysis (≥ 0.5 unit improvement in ACQ-7), and reduction in asthma exacerbations at Weeks 26 and 52. Results A total of 1930 patients were included in this analysis. Medium-dose MF/IND/GLY improved trough FEV1 versus high-dose MF/IND (Δ 41 mL; 95% CI – 7–90) and high-dose FLU/SAL (Δ 88 mL; 95% CI 39–137) at Week 26 which were sustained until Week 52. Exacerbation rates were 16% lower with medium-dose MF/IND/GLY versus high-dose MF/IND for all (mild, moderate, and severe) exacerbations and 21–30% lower versus high-dose FLU/SAL for all (mild, moderate, and severe), moderate or severe, and severe exacerbations over 52 weeks. Further improvements in other lung functions were observed with medium-dose MF/IND/GLY. No new safety signals were identified. Conclusion Medium-dose MF/IND/GLY improved lung function and reduced asthma exacerbations compared to high-dose ICS/LABA and may be an undervalued option in patients at GINA 2022 step 4. Trial Registration ClinicalTrials.gov Identifier: NCT02571777. DA - 2023-08-01 DB - OpenUCT DP - University of Cape Town KW - Asthma exacerbations KW - Glycopyrronium KW - GINA step 4 KW - IRIDIUM KW - Inadequately controlled asthma KW - ICS/LABA KW - LAMA add-on KW - Lung function LK - https://open.uct.ac.za PY - 2023 T1 - Triple Therapy with Mometasone/Indacaterol/Glycopyrronium or Doubling the ICS/LABA Dose in GINA Step 4: IRIDIUM Analyses TI - Triple Therapy with Mometasone/Indacaterol/Glycopyrronium or Doubling the ICS/LABA Dose in GINA Step 4: IRIDIUM Analyses UR - http://hdl.handle.net/11427/38211 ER - | en_ZA |
| dc.identifier.uri | https://doi.org/10.1007/s41030-023-00234-y | |
| dc.identifier.uri | http://hdl.handle.net/11427/38211 | |
| dc.identifier.vancouvercitation | van Zyl-Smit Richard N, Kerstjens Huib A M, Maspero J, Tanase A, Lawrence D, Mezzi K, et al. Triple Therapy with Mometasone/Indacaterol/Glycopyrronium or Doubling the ICS/LABA Dose in GINA Step 4: IRIDIUM Analyses. 2023; http://hdl.handle.net/11427/38211. | en_ZA |
| dc.language.rfc3066 | en | |
| dc.publisher | Springer Healthcare | |
| dc.rights.holder | The Author(s) | |
| dc.subject | Asthma exacerbations | |
| dc.subject | Glycopyrronium | |
| dc.subject | GINA step 4 | |
| dc.subject | IRIDIUM | |
| dc.subject | Inadequately controlled asthma | |
| dc.subject | ICS/LABA | |
| dc.subject | LAMA add-on | |
| dc.subject | Lung function | |
| dc.title | Triple Therapy with Mometasone/Indacaterol/Glycopyrronium or Doubling the ICS/LABA Dose in GINA Step 4: IRIDIUM Analyses | |
| dc.type | Journal Article |