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A Study of Inhaled Fexlamose for Adults with Moderate to Severe Chronic Obstructive Pulmonary Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves adults with Chronic Obstructive Pulmonary Disease, which is a long-term lung condition that makes breathing difficult and gets worse over time. The study focuses on people who have moderate to severe forms of this disease, meaning their lung function is significantly reduced. The treatment being tested is called Fexlamose, which is given as an inhalation solution that is breathed in through a special device called an eFlow Nebulizer. Some participants will receive Fexlamose while others will receive placebo. The purpose of the study is to evaluate how well Fexlamose works compared with placebo in treating this condition.

During the study, participants will continue taking their regular maintenance medications for their lung disease while also receiving either Fexlamose or placebo through inhalation. The treatment period lasts for 28 days, which is 4 weeks. Throughout this time, researchers will measure how well participants can breathe by checking their lung function, specifically looking at how much air they can force out of their lungs in one second. They will also use a computed tomography scan, which is a special type of imaging test that takes detailed pictures of the lungs, to see if there are any changes in the lung tissue. Additionally, participants will complete questionnaires about how their breathing problems affect their daily life and overall health.

The study will monitor participants for any side effects or health changes that might occur during treatment. This includes regular blood tests, urine tests, and measurements of oxygen levels in the blood. Doctors will also check the CT scans to look for any specific changes in the lungs that might be related to the treatment. The entire study is expected to last from early 2026 until the end of 2026, during which time participants will have several visits to the study site for assessments and monitoring.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial screening and lung function assessment

    Your lung function will be tested through spirometry, a breathing test that measures how much air you can breathe out and how quickly. This test will be performed both before and after receiving a medication that opens your airways, called a bronchodilator.

    The spirometry test will be repeated at multiple screening visits to ensure the measurements are consistent. Your baseline lung function measurement before the first dose must be similar to the measurements taken during screening.

    A CT scan of your lungs will be performed to assess the extent of emphysema, which is damage to the air sacs in your lungs. The scan will measure whether less than 40% of your lung tissue shows emphysema.

    Your current medications for chronic obstructive pulmonary disease must remain stable, with no changes in dosage for at least 4 weeks before this screening period and throughout the screening process.

  2. Step 2

    Treatment assignment and baseline measurements

    You will be randomly assigned to receive either Fexlamose inhalation solution or a placebo inhalation solution. A placebo is an inactive solution that looks identical to the study medication but contains no active ingredient.

    Neither you nor the study staff will know which treatment you are receiving. This is called a double-blind study design.

    Before starting treatment, baseline measurements will be taken, including lung function tests, oxygen levels in your blood measured by SpO2, and questionnaires about your respiratory symptoms and quality of life using the SGRQ-C questionnaire.

    Blood and urine samples will be collected to assess your overall health through laboratory tests.

  3. Step 3

    Treatment period with study medication

    You will receive either Fexlamose or placebo as an inhalation solution. This means you will breathe the medication directly into your lungs using an inhaler device.

    The treatment will continue for 4 weeks.

    You will continue taking your regular maintenance medications for chronic obstructive pulmonary disease throughout the study period.

    During this time, any side effects or health changes will be monitored and recorded.

  4. Step 4

    Week 4 assessments

    At the end of the 4-week treatment period, your lung function will be tested again using spirometry before taking your daily bronchodilator medication. The main measurement will be FEV1, which stands for forced expiratory volume in 1 second and measures how much air you can forcefully breathe out in one second.

    Another lung function measurement called FVC, or forced vital capacity, will be taken. This measures the total amount of air you can forcefully breathe out after taking a deep breath.

    A second CT scan of your lungs will be performed to measure changes in mucus plugging, which refers to mucus blocking your airways. This will be assessed using the MPSS score.

    Your blood oxygen levels will be measured again using SpO2.

    You will complete the SGRQ-C questionnaire again to assess any changes in your respiratory symptoms and quality of life.

    Blood and urine samples will be collected for laboratory testing.

    The CT scan will also be reviewed to check for any development of ground-glass opacities, which are hazy areas in the lungs that can be seen on imaging.

  5. Step 5

    Safety monitoring throughout the study

    Throughout the entire study period, any adverse events, meaning any unwanted or harmful effects, will be recorded and assessed.

    Regular laboratory tests will monitor your blood cell counts, kidney and liver function, and urine composition to ensure the treatment is safe.

    Any hospitalizations related to worsening of chronic obstructive pulmonary disease will be documented.

Who can join the trial?

11 criteria

  • You must be between 40 and 80 years old
  • You must have a confirmed diagnosis of COPD (a lung disease that makes it hard to breathe) related to cigarette smoking
  • You must be a current smoker or have smoked in the past, with at least 10 pack years of smoking (this means smoking one pack of cigarettes per day for 10 years, or an equivalent amount)
  • Your lung function test after using a breathing medication must show an FEV1/FVC ratio less than 0.70 (this is a measurement that shows how well air flows out of your lungs)
  • Your lung function before using breathing medication must be between 25% and 60% of what is considered normal, which indicates moderate to severe COPD
  • You must be able to perform breathing tests (called spirometry) correctly and consistently during screening visits
  • Your lung function measurements must remain stable between screening visits
  • A CT scan (a special X-ray picture of your lungs) must show that less than 40% of your lungs have emphysema (damage to the air sacs in the lungs)
  • You must have been using the same inhaler medications for your COPD without any dose changes for at least 4 weeks before joining the study
  • You must be using maintenance medications that include an inhaled bronchodilator (a medicine that helps open your airways to make breathing easier)
  • You must have had no more than 2 severe COPD flare-ups (called exacerbations) that required hospital admission in the past year

Who cannot join the trial?

4 criteria

  • The source data does not provide specific exclusion criteria, which are the reasons why someone cannot participate in this study
  • Without detailed information about who cannot join the study, it is not possible to list the specific medical conditions, medications, or other factors that would prevent participation
  • Generally, clinical trials have rules about who can and cannot participate to ensure the safety of participants and the accuracy of the study results
  • These rules typically cover things like other health problems, medications you are taking, or previous treatments you have received
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Investigated drugs

  • Fexlamose (AER 01) Inhalation Solution

    is an experimental medication being tested in this study. It is given as an inhalation solution, which means patients breathe it in through their lungs. This medication is being studied to see if it can help adults who have moderate to severe chronic obstructive pulmonary disease, a lung condition that makes breathing difficult. The study will look at whether this medication works better than placebo and whether it is safe for patients to use.

  • Placebo

    is an inactive treatment that looks like the real medication but contains no active medicine. It is used in this study to compare against the experimental medication to help researchers understand if the real medication is actually working.

What is already known about the treatment

Fexlamose (AER-01) – Fexlamose is an investigational inhaled medication currently being studied in clinical trials for the treatment of moderate to severe chronic obstructive pulmonary disease (COPD), a lung condition that makes it difficult to breathe. The medication is delivered directly to the lungs through inhalation solution, allowing it to work where it is needed most. While the exact way fexlamose works at the cellular level is not fully detailed in available trial information, it is being tested to see if it can improve lung function and reduce symptoms better than a placebo (inactive treatment) in adults with COPD. As an experimental drug, fexlamose is not yet approved for general medical use and is still undergoing evaluation to determine its safety, effectiveness, and how well patients tolerate it.

Investigated diseases

Chronic Obstructive Pulmonary Disease – Chronic Obstructive Pulmonary Disease is a long-term lung condition that makes it difficult to breathe. The disease develops gradually over many years, usually caused by smoking or long-term exposure to harmful particles and gases. The airways in the lungs become narrowed and damaged, and the air sacs lose their ability to stretch properly. As the disease progresses, people experience increasing shortness of breath, persistent cough, and frequent chest infections. The lungs produce excess mucus, which can block the airways and make breathing even harder. Physical activities become more challenging as the condition advances, and breathing difficulties may occur even during rest in later stages.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523020-50-00Protocol codeAER-01-002Estimated enrolment100 patientsSponsorAer Therapeutics Inc.

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