Trial reportBMC pulmonary medicine2025
Evening administration of long-acting muscarinic antagonists in COPD - a randomized controlled trial.
Trial report in BMC pulmonary medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05563675 (Comparing Morning and Evening Dosing of Inhaled Long-Acting Muscarinic Antagonists for the Prevention of Hospitalization Requiring AECOPD or Death from All Causes - the LAMA by Night Study Utilizing a Comprehensive Nationwide Digital Platform for Recruitment Into a Pragmatic Randomized Controlled Trial Integrated with National Registries to Follow Outcomes), which is not on this map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Comparing Morning and Evening Dosing of Inhaled Long-Acting Muscarinic Antagonists for the Prevention of Hospitalization Requiring AECOPD or Death from All Causes - the LAMA by Night Study Utilizing a Comprehensive Nationwide Digital Platform for Recruitment Into a Pragmatic Randomized Controlled Trial Integrated with National Registries to Follow Outcomes
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Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundNight-time parasympathetic activation, diminished effect of long-acting muscarinic antagonists (LAMA) closer to end of the dosing period, and frequent exacerbations in chronic obstructive pulmonary disease (COPD) during night suggests greater benefits of evening administration of once-daily LAMA.
methodsWe electronically invited 172,852 Danish COPD patients who used once-daily LAMA (including dual/triple therapy) to participate in a randomized controlled, digital platform, pragmatic trial comparing evening with morning LAMA administration. Of these, 10,011 patients consented and were randomized. National health registries were the main source for follow-up data. The primary endpoint was a composite of COPD exacerbations requiring hospitalization or all-cause death within one year. Secondary endpoints were moderate COPD exacerbations, all-cause hospitalization, intensive-care admission, non-invasive ventilation, all-cause mortality, and consumption of short-acting beta-2-agonists.
resultsA total of 10,011 COPD patients were randomized to evening (n=4,983) or morning (n=5,028) LAMA administration. We had complete (100%) follow-up on the primary and secondary outcomes. In the evening-LAMA group, 245 persons (5%) met the primary outcome compared with 249 persons (5%) in the morning-LAMA group (P=0.93). There were 61 (1%) intensive-care admissions in the evening-LAMA group versus 95 (2%) in the morning-LAMA group (P=0.046). Other secondary outcomes were neutral. Administration-time adherence was low in the evening-LAMA group being 73% at 6 months and 66% at 12 months among survey responders (65% and 63%, respectively).
conclusionsEvening administration of LAMA did not reduce the incidence of COPD exacerbations requiring hospitalization or all-cause death. Poor adherence may have contributed to the negative study outcome. The trial serves as a proof-of-concept for decentralized digital trials.
trial registrationClinicaltrials.gov: NCT05563675, registered 28/09/2022 https://clinicaltrials.gov/study/NCT0556367 .
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