Authorised Therapeutic exploratory (Phase II) Chronic Obstructive Pulmonary Disease

A Study to Investigate Using Inhaled Fexlamose to Treat Adult Participants Who Have Moderate to Severe COPD

EU CTIS ID: 2025-523020-50-00

What this study is testing

To evaluate the efficacy of AER-01 compared with placebo

Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1. The study will enroll participants with a diagnosis of COPD. Each participant must meet all the following criteria to be enrolled in this study: • Is male or female ≥40 to ≤80 years of age.
2. Has a verified diagnosis of cigarette smoking-related COPD demonstrated by both of the following: o Is a current or former smoker with a history of ≥10 pack years of cigarette smoking. o Has a postbronchodilator FEV1/FVC ratio <0.70.
3. Has moderate to severe COPD defined in this study as a prebronchodilator FEV1 that is >25% and <60% of predicted normal at Visit 1.
4. Participant meets the following spirometry performance criteria: o Acceptability: Participant can perform acceptable spirometry (ie, meet ATS/ERS acceptability criteria) at Visits 1 and 2. o Repeatability: Participant can perform technically acceptable spirometry meeting repeatability criteria for FEV1 during ≥1 of the prebronchodilator assessments at Visits 1 and 2. o Participant’s baseline (predose) FEV1 at Visit 3 must be within the greater of 12% or 100 mL of the mean FEV1 obtained at the 2 Screening visits.
5. Participant has a whole lung emphysema percent <40% based on automated analysis of the CT lung scan
6. Participant is on stable maintenance inhaler medications for COPD with no dose adjustments for ≥4 weeks prior to Screening and during the Screening Period.

You likely can't join if

1. Participants meeting any of the following criteria will be excluded from the study: • Participant has an active uncontrolled medical condition that, in the opinion of the investigator or medical monitor, might obfuscate the study data. Examples of such medical conditions that, if uncontrolled at Visit 1, would be exclusionary include: hypertension, diabetes, renal failure, coronary artery disease, cardiac failure, gastro esophageal reflux disease, cancer, alcohol use disorder, illicit drug use, or psychiatric disease.
10. Participant has active lung infection with nontuberculous mycobacteria, Pseudomonas aeruginosa, or Staphylococcus aureus.
11. Participant has received any vaccine within 7 days prior to Day 1.
12. Participant is using dupilumab or tezepelumab for control of COPD, or any medical condition. Note: Patients who are taking benralizumab, mepolizumab, or omalizumab at a stable dose for ≥6 months are not excluded.
13. Participant has a hypersensitivity to fexlamose or to any of the excipients or placebo components.
14. Participant has active or latent pulmonary tuberculosis.

See the full eligibility criteria

Who can join

1. The study will enroll participants with a diagnosis of COPD. Each participant must meet all the following criteria to be enrolled in this study: • Is male or female ≥40 to ≤80 years of age.
2. Has a verified diagnosis of cigarette smoking-related COPD demonstrated by both of the following: o Is a current or former smoker with a history of ≥10 pack years of cigarette smoking. o Has a postbronchodilator FEV1/FVC ratio <0.70.
3. Has moderate to severe COPD defined in this study as a prebronchodilator FEV1 that is >25% and <60% of predicted normal at Visit 1.
4. Participant meets the following spirometry performance criteria: o Acceptability: Participant can perform acceptable spirometry (ie, meet ATS/ERS acceptability criteria) at Visits 1 and 2. o Repeatability: Participant can perform technically acceptable spirometry meeting repeatability criteria for FEV1 during ≥1 of the prebronchodilator assessments at Visits 1 and 2. o Participant’s baseline (predose) FEV1 at Visit 3 must be within the greater of 12% or 100 mL of the mean FEV1 obtained at the 2 Screening visits.
5. Participant has a whole lung emphysema percent <40% based on automated analysis of the CT lung scan
6. Participant is on stable maintenance inhaler medications for COPD with no dose adjustments for ≥4 weeks prior to Screening and during the Screening Period.
7. Participant has maintenance medications, including an inhaled bronchodilator (short- or long acting beta adrenergic agonist or short- or long acting muscarinic antagonist).
8. Participant has had ≤2 COPD exacerbations requiring hospitalization in the past year.

What rules you out

1. Participants meeting any of the following criteria will be excluded from the study: • Participant has an active uncontrolled medical condition that, in the opinion of the investigator or medical monitor, might obfuscate the study data. Examples of such medical conditions that, if uncontrolled at Visit 1, would be exclusionary include: hypertension, diabetes, renal failure, coronary artery disease, cardiac failure, gastro esophageal reflux disease, cancer, alcohol use disorder, illicit drug use, or psychiatric disease.
10. Participant has active lung infection with nontuberculous mycobacteria, Pseudomonas aeruginosa, or Staphylococcus aureus.
11. Participant has received any vaccine within 7 days prior to Day 1.
12. Participant is using dupilumab or tezepelumab for control of COPD, or any medical condition. Note: Patients who are taking benralizumab, mepolizumab, or omalizumab at a stable dose for ≥6 months are not excluded.
13. Participant has a hypersensitivity to fexlamose or to any of the excipients or placebo components.
14. Participant has active or latent pulmonary tuberculosis.
15. Participant has moderate or severe abnormalities in liver or renal function tests at Screening (ie, Grade >2 abnormalities).
2. Participant has primary diagnosis of non-CF bronchiectasis, primary ciliary dyskinesia, allergic bronchopulmonary aspergillosis, or CF.
3. Participant has a finding on their screening CT lung scan of varicose or cystic bronchiectasis affecting >1 lobe or of cylindrical bronchiectasis affecting >2 lobes.
4. Participant has a finding on their screening CT lung scan of "tree in bud" opacities (indicative of small airway inflammation/infection).
5. Participant has a lung nodule discovered on their screening CT lung scan that, in the opinion of the site investigator, requires a timely work-up that would be adversely affected by participation in the study. In making this assessment, the site investigator should consider the size and appearance of the nodule and the guidance provided by the Fleischner Society.
6. Participant has had a COPD exacerbation in the 6 weeks prior to Visit 1 (Screening) or during the Screening Period (Visit 1 to Visit 3).
7. Participant has had a viral respiratory tract infection (including coronavirus) in the 4 weeks prior to Screening.
8. Participant is currently using any vaping product or has used a vaping product within 1 week of signing the informed consent.
9. Participant is currently smoking cannabis or has smoked cannabis within 1 week of signing the informed consent.

The study team makes the final eligibility decision.

Where it's taking place

United Kingdom
New Zealand
Australia

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United Kingdom; New Zealand; Australia. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.