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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 (AEOLUS)

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521268-37-00
Acronym
LPS18583
Enrollment
184
Registered
2025-09-29
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory tract diseases

Brief summary

Change from baseline to Week 24 in global lung mucus score (UCSF mucus scoring)

Detailed description

Change from baseline to Week 24 in mucus volume for global lung by High-resolution Computed Tomography (HRCT), Change from baseline to Week 24 in trimmed distal airway wall thickness at TLC by HRCT, Change from baseline to Week 24 in airway resistance from R5 to R20 measured by Forced Oscillation Technique (FOT), Change from baseline to Week 24 in Reactance area (AX) measured by FOT, Incidence of Treatment-Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Adverse Event of Special Interest (AESI) including potentially clinically significant abnormalities

Interventions

Sponsors

Sanofi-Aventis Recherche & Developpement
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change from baseline to Week 24 in global lung mucus score (UCSF mucus scoring)

Secondary

MeasureTime frame
Change from baseline to Week 24 in mucus volume for global lung by High-resolution Computed Tomography (HRCT), Change from baseline to Week 24 in trimmed distal airway wall thickness at TLC by HRCT, Change from baseline to Week 24 in airway resistance from R5 to R20 measured by Forced Oscillation Technique (FOT), Change from baseline to Week 24 in Reactance area (AX) measured by FOT, Incidence of Treatment-Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Adverse Event of Special Interest (AESI) including potentially clinically significant abnormalities

Countries

Austria, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026