Language: BG BG
← Back to results
Active (not recruiting) Phase 4 2025-521268-37-00

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)

Phase 4 – monitoring after market approval
Conditions: Respiratory tract diseases

Sponsor: Sanofi-Aventis Recherche & Developpement

trial.available_in: БГ
Overview
Trial status: Authorised 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 Change from baseline to Week 24 in global lung mucus score (UCSF mucus scoring)
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
Who can participate
Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 184 participants
Interventions
Dupilumab
Drug
matched placebo for test product
Drug
Ventolin Evohaler 100 micrograms
Drug
Locations 10
Austria (1)
Denmark (1)
France (1)
Germany (1)
Hungary (1)
Italy (1)
Netherlands (1)
Poland (1)
Spain (1)
Sweden (1)
Technical details
Status
Active (not recruiting)
Phase
Phase 4
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
29.09.2025
Registry ID
2025-521268-37-00
Source
euclinicaltrials.eu
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.