Dupilumab for COPD
(AEOLUS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests dupilumab, an injectable medication, to assess its effects on individuals with Chronic Obstructive Pulmonary Disease (COPD). The focus is on reducing lung inflammation and improving breathing and quality of life. Participants will receive either dupilumab or a placebo injection to compare outcomes. The trial suits those with moderate-to-severe COPD, who are current or former smokers with a history of at least 10 pack-years, and who experience frequent or severe flare-ups despite regular COPD medication. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients.
Do I need to stop my current medications for the trial?
The trial requires that you have been on a stable dose of your current COPD medications (triple therapy or dual therapy) for at least one month before starting. It doesn't specify stopping other medications, but you should discuss your current medications with the trial team.
What is the safety track record for this treatment?
Research has shown that dupilumab is generally safe for people with COPD, a lung disease. Studies have found that it can lead to fewer emergency room visits and reduce the risk of flare-ups, indicating it is usually well-tolerated. Other research indicates that patients using dupilumab had better lung function and fewer symptoms compared to those who received a placebo. In one study, 36% of 938 patients experienced moderate or severe flare-ups over a year, which is common with COPD. Overall, these findings suggest that while dupilumab is generally safe for people with COPD, some risk of flare-ups remains.12345
Why are researchers enthusiastic about this study treatment?
Most treatments for COPD (Chronic Obstructive Pulmonary Disease) focus on easing symptoms with bronchodilators or corticosteroids. But Dupilumab works differently, targeting the underlying inflammation by blocking specific proteins involved in the inflammatory response. This unique mechanism offers the potential to reduce flare-ups and improve lung function more effectively. Researchers are excited about Dupilumab because it represents a shift from merely managing symptoms to addressing the root causes of COPD.
What is the effectiveness track record for dupilumab in treating COPD?
Research shows that dupilumab, which participants in this trial may receive, effectively treats chronic obstructive pulmonary disease (COPD). Studies have found that it can reduce flare-ups, aid breathing, and enhance overall quality of life. Patients using dupilumab experienced fewer severe symptoms compared to those taking a placebo. Additionally, dupilumab has been linked to improved lung function and reduced airway swelling. This treatment has a strong track record of helping people with COPD manage their symptoms more effectively.34678
Are You a Good Fit for This Trial?
This trial is for people aged 40-85 with moderate-to-severe COPD who are current or former smokers. They must have a history of frequent exacerbations, be on stable triple or dual therapy if intolerant to ICS, and show signs of Type 2 inflammation. Those with significant breathing difficulty (MRC grade ≥2) or high symptom scores (CAT score ≥10) and mucus issues can join.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive subcutaneous injections of either dupilumab or placebo for 24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dupilumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sanofi
Lead Sponsor
Paul Hudson
Sanofi
Chief Executive Officer since 2019
Degree in Economics from Manchester Metropolitan University
Christopher Corsico
Sanofi
Chief Medical Officer
MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University
Regeneron Pharmaceuticals
Industry Sponsor
Leonard Schleifer
Regeneron Pharmaceuticals
Chief Executive Officer since 1988
MD and PhD in Medicine
George Yancopoulos
Regeneron Pharmaceuticals
Chief Medical Officer since 1997
MD from Harvard Medical School