AEOLUS - COPD (LPS18583)

• Research type

  Research Study

• Full title

  A randomised, 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.

• IRAS ID

  1012199

• Contact name

  Patrick Maury

• Contact email

  patrick.maury@sanofi.com

• Sponsor organisation

  Sanofi-Aventis Recherche and Développement

• Eudract number

  2025-521268-37

• Research summary

  This study examines how dupilumab affects airway inflammation and mucus build-up in people with chronic obstructive pulmonary disease (COPD). COPD is a serious lung condition that makes breathing difficult and affects daily life. This study will provide mechanistic insights into how dupilumab can improve breathing and quality of life of COPD patients by reducing mucus build-up and airway inflammation.

  The primary endpoint is the change from baseline to Week 24 in global lung mucus scoring. Secondary endpoints include changes in mucus volume, airway wall thickness, and airway resistance.

  The study is a randomised, double-blind, placebo-controlled, phase 4 study. Participants will be randomly assigned to receive dupilumab or placebo. This works like flipping a coin. “Double-blind” means that neither the participant, nor the study doctors know who is given dupilumab or placebo. This is done to make sure that the study results are not influenced in any way.

  This study will include 218 adults aged 40-85 from 23 countries worldwide. Patients must have moderate to severe COPD, a history of frequent COPD flare-ups and be on established LABA, LAMA, and ICS triple background therapy (unless ICS is contraindicated).

  The study includes:
  - A 3-week screening period
  - A 24-week treatment period during which patients will receive either dupilumab or placebo injections every 2 weeks
  - A 12-week post-treatment follow-up period

  Throughout the study, participants will have:
  - Regular clinic visits for health checks
  - Lung function tests
  - CT scans to examine their airways
  - Quality of life questionnaires
  
  A subset of 62 participants will also participate in a sub study to assess ventilation and gas exchange using specialised 129Xe MRI scans and sputum induction.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  25/SC/0187

• Date of REC Opinion

  15 Aug 2025

• REC opinion

  Further Information Favourable Opinion