Phase2a study to evaluate fexlamose inhalation solution in adults with moderate to severe COPD
Research type
Research Study
Full title
A Phase 2a, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fexlamose (AER-01) Inhalation Solution in the Treatment of Adults with Moderate to Severe Chronic Obstructive Pulmonary Disease
IRAS ID
1010770
Contact name
Jordan Low
Contact email
Sponsor organisation
Aer Therapeutics, Inc.
Research summary
Chronic Obstructive Pulmonary Disease (COPD) is a long-term (chronic) condition where the air sacs (alveoli) in the lungs are damaged, and/or the airways (bronchial tubes) of the lungs are blocked with mucus or narrowed by swelling (inflammation) or tightening of the muscles in the . airway wall. These features of COPD make it hard to breathe and the symptoms of COPD include cough, sputum (phlegm) production, and feelings of shortness of breath and chest congestion.
This study will test if an investigational drug called fexlamose is safe and effective in patients with moderate to severe COPD. Fexlamose works by breaking up mucus plugs in the lungs, which could improve lung symptoms and lung function. Fexlamose is a liquid solution that is inhaled through a machine called a nebuliser. A nebuliser turns the solution from a liquid into a fine mist, making it possible to breathe the study drug into the lungs.
The purpose of this study is to test the safety and effectiveness of fexlamose in people with moderate to severe COPD. The study will involve approximately 100 participants who will be recruited from multiple countries. Participants will randomly be assigned to:
- Fexlamose – this group will receive the study drug
- Placebo – this group will receive a substance that looks like fexlamose but does not have any medicine
Participants will have a 50% chance of receiving fexlamose. This is a "double-blind" study, which means that neither the participant nor the study staff will know which group any participant is in.
Participants will be in the study for up to 10 weeks and will have approximately 7 site visits and 1 phone call. These study visits will include multiple procedures, such as blood samples, completion of symptom questionnaires, physical examination, lung function tests, and computed tomography (CT) lung scans.REC name
South Central - Oxford B Research Ethics Committee
REC reference
25/SC/0076
Date of REC Opinion
10 Apr 2025
REC opinion
Further Information Favourable Opinion