Eosinophil-driven Corticotherapy for Patients Hospitalized for COPD

Status Recruiting

Clinical Trial Summary

The primary objective of this study is to compare treatment failure rates between a group of eosinophilic (eosinophilia > 2% on day 1 of hospitalization) patients hospitalised for a COPD exacerbation treated via corticotherapy versus a similar group treated via placebo. Secondarily, treatment failure rates will also be compared between a group of non-eosinophilic patients hospitalised for a COPD exacerbation treated via corticotherapy versus a similar group treated via placebo. Study arms will also be compared for additional aspects of efficacy and safety: - speed of recovery during the initial hospitalization; - corticosteroid side effects / induced comorbidities; - changes in symptoms and episodes of exacerbation; - pulmonary function, oxygen use and ventilation; - patient trajectories and resource use (e.g. survival, consults, episodes of hospitalization, medications); - drug consumption (especially as relates to COPD management, exacerbations and induced comorbidities); - health status, quality of life, activity/disability; - patient safety / adverse events in general. Eosinophilia thresholds optimizing the prediction of corticosteroid response and COPD outcomes will be re-evaluated. The relationships between corticosteroid response and key biomarkers (e.g. infectious groups) will be thoroughly explored, including within eosinophil strata. Potential gender subgroups differences will also be evaluated. Finally, in prevision of further exploratory studies, a biological collection and an imaging library will be created in association with this protocol. The biological collection will be used to explore the genetic basis and physiology linked with treatment response, gender and patient trajectories. The image library will be used as a platform for the exploration of new imaging markers developed, for example, via machine learning and affiliated techniques.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

COPD Exacerbation
Pulmonary Disease, Chronic Obstructive

Clinical Trial Details

NCT number	NCT04234360
Study type	Interventional
Source	University Hospital, Montpellier
Contact	Arnaud BOURDIN
Phone	0033467336126
Email	a-bourdin@chu-montpellier.fr
Status	Recruiting
Phase	Phase 3
Start date	October 12, 2021
Completion date	January 12, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Eosinophil-driven Corticotherapy for Patients Hospitalized for COPD Exacerbation — eo-Drive

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms