Dupilumab
DrugPharmaceutical form:Solution for injection-Route of administration:SC injection
Other names: SAR231893, Dupixent
NCT Number: NCT07053423
LPS18583 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 4 study with 2 treatment groups. The purpose of this study is to assess the effect of dupilumab compared with placebo on airway inflammation, resistance, and remodeling including mucus plugging and its association with improvement on lung function, exacerbations, and quality of life improvement in participants aged 40 years of age up to 85 years of age (inclusive).
Study details include:
The study duration will be up to 40 weeks. The treatment duration will be up to 24 weeks. The number of visits will be 9.
Interested in participating?
Request Info40 year–85 year
All sexes
Interventional
Phase 4
Investigational Site Number : 0320001, San Miguel de Tucumán, Tucumán Province, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Participants with a physician diagnosis of Chronic Obstructive Pulmonary Disease (COPD) who meet the following criteria at screening:
Exclusion criteria
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Pharmaceutical form:Solution for injection-Route of administration:SC injection
Other names: SAR231893, Dupixent
Pharmaceutical form:Solution for injection-Route of administration:SC injection
Time frame: Baseline to Week 24
The score is calculated by counting the number of bronchopulmonary segments which on CT scans contain at least one mucus plugs. The score ranges from 0 up to a maximum score of 18 corresponding to the 18 bronchopulmonary segments present in most people. In this system, a mucus plug is defined as a complete occlusion of the airway imaged at Total Lung Capacity (TLC). Higher scores indicate worse outcome.
Time frame: Baseline to Week 24
Time frame: Baseline to Week 24
Time frame: Baseline to Week 24
Time frame: Baseline to Week 24
Time frame: Baseline to Week 36
Contact information is provided by the study sponsor or research team.
Sanofi
Industry
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Dupilumab on Airway Inflammation Through Assessments of Mucus Plugging and Other Lung Imaging Parameters in Patients With Chronic Obstructive Pulmonary Disease.
Acronym: AEOLUS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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