AM/PM dosing of LAMA for COPD: a randomized controlled trial protocol using digital recruitment and registries
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AM/PM dosing of LAMA for COPD : a randomized controlled trial protocol using digital recruitment and registries. / Sivapalan, Pradeesh; Rømer, Valdemar; Klausen, Tobias Wirenfeldt; Johansen, Niklas Dyrby; Pareek, Manan; Modin, Daniel; Mathioudakis, Alexander; Vestbo, Jørgen; Eklöf, Josefin; Jordan, Alexander; Hurst, John R.; Biering-Sørensen, Tor; Jensen, Jens Ulrik.
I: Frontiers in Medicine, Bind 11, 1430169, 2024.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - AM/PM dosing of LAMA for COPD
T2 - a randomized controlled trial protocol using digital recruitment and registries
AU - Sivapalan, Pradeesh
AU - Rømer, Valdemar
AU - Klausen, Tobias Wirenfeldt
AU - Johansen, Niklas Dyrby
AU - Pareek, Manan
AU - Modin, Daniel
AU - Mathioudakis, Alexander
AU - Vestbo, Jørgen
AU - Eklöf, Josefin
AU - Jordan, Alexander
AU - Hurst, John R.
AU - Biering-Sørensen, Tor
AU - Jensen, Jens Ulrik
N1 - Publisher Copyright: Copyright © 2024 Sivapalan, Rømer, Wirenfeldt Klausen, Dyrby Johansen, Pareek, Modin, Mathioudakis, Vestbo, Eklöf, Jordan, Hurst, Biering-Sørensen and Jensen.
PY - 2024
Y1 - 2024
N2 - Rationale: Long-acting muscarinic antagonists (LAMAs) reduce the risk of acute exacerbations of chronic obstructive pulmonary disease (AECOPD), usually taken once daily in the morning. However, the circadian activity of autonomic regulation suggests that the highest need for anticholinergic therapy may be in the late night/early morning. This is supported by evidence that AECOPD most often begins in the morning. Furthermore, the trough spirometry effect of LAMA is lower than the peak effect, which further argues that evening dosing may be more optimal than morning dosing. This trial aims to determine whether evening administration of LAMA reduces hospitalization-requiring AECOPD or death from all causes within 1 year as compared to morning administration of the same LAMA. Methods: Randomized controlled open-label trial. Persons aged 30 years or older with a once-daily LAMA prescription and a confirmed COPD diagnosis were recruited. Participants were randomized in a 1:1 ratio to either morning or evening LAMA administration. Complete follow-up for the primary outcome, hospitalization-requiring AECOPD, or death from all causes within 1 year was captured from the Danish National Health Register, as were patient-reported outcome assessments at 6 and 12 months. Results: A total of 10,013 participants were randomized, and the recruitment process started on 9 March 2023. Secondary outcomes include (i) moderate COPD exacerbations; (ii) all-cause hospitalization; (iii) ICU admission; (iv) need for non-invasive ventilation; and (v) all-cause mortality, among others. All outcomes will be evaluated 12 months after recruitment. Clinical trial registration:ClinicalTrials.gov, NCT05563675.
AB - Rationale: Long-acting muscarinic antagonists (LAMAs) reduce the risk of acute exacerbations of chronic obstructive pulmonary disease (AECOPD), usually taken once daily in the morning. However, the circadian activity of autonomic regulation suggests that the highest need for anticholinergic therapy may be in the late night/early morning. This is supported by evidence that AECOPD most often begins in the morning. Furthermore, the trough spirometry effect of LAMA is lower than the peak effect, which further argues that evening dosing may be more optimal than morning dosing. This trial aims to determine whether evening administration of LAMA reduces hospitalization-requiring AECOPD or death from all causes within 1 year as compared to morning administration of the same LAMA. Methods: Randomized controlled open-label trial. Persons aged 30 years or older with a once-daily LAMA prescription and a confirmed COPD diagnosis were recruited. Participants were randomized in a 1:1 ratio to either morning or evening LAMA administration. Complete follow-up for the primary outcome, hospitalization-requiring AECOPD, or death from all causes within 1 year was captured from the Danish National Health Register, as were patient-reported outcome assessments at 6 and 12 months. Results: A total of 10,013 participants were randomized, and the recruitment process started on 9 March 2023. Secondary outcomes include (i) moderate COPD exacerbations; (ii) all-cause hospitalization; (iii) ICU admission; (iv) need for non-invasive ventilation; and (v) all-cause mortality, among others. All outcomes will be evaluated 12 months after recruitment. Clinical trial registration:ClinicalTrials.gov, NCT05563675.
KW - all-cause mortality
KW - chronic obstructive pulmonary disease
KW - COPD exacerbation
KW - intensive care admission
KW - long-acting muscarinic antagonists
U2 - 10.3389/fmed.2024.1430169
DO - 10.3389/fmed.2024.1430169
M3 - Journal article
C2 - 39165373
AN - SCOPUS:85201527816
VL - 11
JO - Frontiers in Medicine
JF - Frontiers in Medicine
SN - 2296-858X
M1 - 1430169
ER -
ID: 402678036