AER Therapeutics AER-01-002

Phase 2a randomised placebo-controlled study to evaluate the efficacy, safety and tolerability of Fexlamose (AER-01) inhalation solution in adults with moderate to severe COPD. 

Study Population

Approximately 100 participants are planned to be randomized in to this study.

This studyis designed to investigate whether Fexlamose inhalation will improve lung function and decrease mucus plugging, as evidenced on CT scan.

Eligible participants:

• male or female, between 40 and 80 years of age.
• Current or former smoker.
• Lung function with FEV1 between 25% and 60%.
• CT lung scan which shows evidence of mucus plugging and emphysema.
• Has had less than 2 COPD exacerbations in the last 12 months (requiring urgent care or hospitalisation).

Subjects with an undiagnosed or unstable disease, currently using vaping products or cannabis, or being treated with an injectable biologic (Nucala, Fasenra, Dupixent) will not be eligible to participate in the study.

Study Visits

• A total of 8 visits over a 2‑month period.
• The planned study duration for each participant is approximately 10 weeks, comprising the Screening Period (up to 4 weeks), the Treatment Period (4 weeks), and the Follow-up Period (2 weeks).

Study Requirements

• Inhaled nebulised medication once every morning (provided by ePari).
• Lung function test, blood tests, ECG at selected onsite visits.
• CT scan at study entry and at Week 4.
• Completion of questionnaires on electronic diary
• Blood tests.
  

Clinical Trials Link

https://clinicaltrials.gov/study/NCT06731959