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. 

Who can take part?

You may be able to take part if you have chronic obstructive pulmonary disease (COPD), a condition that affects the lungs and can make breathing difficult.

You may be eligible if you:

• Are 40 to 80 years of age
• Are a current or former smoker
• Have moderate to severe COPD based on lung function testing
• Have a CT scan showing mucus build-up in the lungs
• Have had fewer than two COPD flare-ups in the past 12 months

You would not be able to take part if:

• You have an unstable or undiagnosed health condition
• You currently use vaping products or cannabis
• You are receiving certain injectable treatments for lung disease
• The study doctor feels that participation may not be safe for you

What is involved?

This study is looking at whether Fexlamose, an inhaled investigational medication, may help improve lung function and reduce mucus build-up in the lungs.

Participants will be randomly assigned to receive the study medication.

• Study duration: Approximately 10 weeks
• Clinic visits: 8 visits during the study

The study includes:

• A screening period (up to 4 weeks)
• A treatment period (4 weeks)
• A follow‑up period (2 weeks)

What will I need to do?

If you take part, you will be asked to:

• Take the study medication once daily using a nebuliser
• Attend clinic visits and study appointments
• Take part in assessments, which may include:
• • Breathing tests
  • Blood tests
  • A heart tracing (ECG)
  • CT scans at the start of the study and during treatment
  • Questionnaires about your health

You will also be asked to record information using an electronic diary.

More information

You can read more about this study here:

• ClinicalTrials.gov – Fexlamose Study