Once Daily Long-Acting Muscarinic Antagonists Administered in the Evening for Prevention of Chronic Obstructive Pulmonary Disease Exacerbations Requiring Hospitalization or Death from Any Cause

NCT05563675 | Completed Phase 4 DMC

• 1 other identifier: Protocol_LAMA
• Study Type: interventional
• Target: 10,011
• Locations: 1 country
• Sites: 1

Brief Summary

To examine, among once-daily LAMA using COPD patients, whether evening administration of LAMA is superior with respect to the incidence of hospitalization requiring AECOPD or death from all causes than the more conventional morning administration.

Conditions

COPD Exacerbation

Keywords

LAMA; Bedtime administration

Outcome Measures

Primary Outcomes (2)

• COPD-related hospitalization-requiring (severe) exacerbations

  12 months from randomization

• All-cause mortality

  12 months from randomization

Secondary Outcomes (8)

• Moderate, non-hospitalization-requiring COPD exacerbations

  12 months from randomization

• Number of admissions for all causes

  12 months from randomization

• Number of admissions in the intensive care unit (ICU) for all causes

  12 months from randomization

• Number of admissions requiring non-invasive ventilation (NIV) treatment

  12 months from randomization

• Mortality (all-cause)

  12 months from randomization

Study Arms (2)

Morning administration of LAMA

NO INTERVENTION

Participants randomized to this group (with or without the combination of ICS and/or LABA) will be instructed to take their LAMA as usual in the morning between 6 and 12am.

Bedtime administration of LAMA

EXPERIMENTAL

Participants randomized to this group (with or without the combination of inhaled corticosteroids (ICS) and/or long-acting beta2-agonists (LABA)) will be instructed to take their LAMA-containing inhalation between 8pm. and 2am.

Drug: Long acting muscarinic antagonists (LAMAs) in the evening

Interventions

Long acting muscarinic antagonists (LAMAs) in the evening DRUG

LAMAs administered at bedtime (8pm - 2am)

Bedtime administration of LAMA

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age more than or equal to 30 years
• Current treatment with LAMA once daily (as recorded in the Danish National Prescription Registry and confirmed by the participant via questionnaire)
• Self-reported COPD

You may not qualify if:

• \. Patients who decline to participate.

Sponsors & Collaborators

• Chronic Obstructive Pulmonary Disease Trial Network, Denmark: lead

Study Sites (1)

Herlev-Gentofte Hospital

Copenhagen, Denmark

Location

Related Publications (2)

• Sivapalan P, Romer V, Jordan A, Johansen ND, Pareek M, Modin D, Mathioudakis AG, Vestbo J, Vognsen AK, Eklof J, Hurst JR, Klausen TW, Biering-Sorensen T, Jensen JS. Evening administration of long-acting muscarinic antagonists in COPD - a randomized controlled trial. BMC Pulm Med. 2025 Dec 3;25(1):552. doi: 10.1186/s12890-025-03952-y.

  PMID: 41340061 DERIVED

• Sivapalan P, Romer V, Wirenfeldt Klausen T, Dyrby Johansen N, Pareek M, Modin D, Mathioudakis A, Vestbo J, Eklof J, Jordan A, Hurst JR, Biering-Sorensen T, Jensen JU. AM/PM dosing of LAMA for COPD: a randomized controlled trial protocol using digital recruitment and registries. Front Med (Lausanne). 2024 Aug 6;11:1430169. doi: 10.3389/fmed.2024.1430169. eCollection 2024.

  PMID: 39165373 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators will be blinded for the treatment allocation, but the trial participants will not be blinded. However, since all endpoints are assessed using prespecified registry-based definitions, bias should be negligible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized 1:1 to one of two treatment strategies by computer-generated allocation, to either LAMA administration in the morning or evening. Randomization groups will be allocated according to a computer-generated randomization. Data will be entered by participants directly into REDCap questionnaires. Consent and randomization will take place on day 0. The result of the randomization will be shown directly to the participant on their screen and sent to the participant's official electronic mailbox.

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: October 3, 2022
• Study Start: January 27, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)