COPDPhase 2AER-01-002NCT06731959
A Study to Investigate Using Inhaled Fexlamose to Treat Adult Participants Who Have Moderate to Severe COPD
A Phase 2 study testing Flexlamose in people with COPD, run by Aer Therapeutics.
Trial summary
AER-01-002 is a Phase 2a study being conducted to determine if inhaled fexlamose is an effective and safe treatment for adults with moderate to severe COPD. Study will compare active drug to placebo. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- Flexlamose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Jan 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria
Each participant must meet all the following criteria to be enrolled in this study:
- Participant is male or female ≥40 to ≤80 years of age.
- Participant has a verified diagnosis of cigarette smoking-related COPD FEV1 that is >25% and <60% of predicted normal at Visit 1.
- Participant meets the following spirometry performance criteria:
- Acceptability: Participant can perform acceptable spirometry (ie, meet ATS/ERS acceptability criteria) at Visits 1 and 2.
- Repeatability: Participant can perform technically acceptable spirometry meeting repeatability criteria for FEV1 during at least 1 of the prebronchodilator assessments at Visits 1 and 2.
- Participant is on stable maintenance COPD medications with no dose adjustments for ≥4 weeks prior to Screening and during the Screening Period.
- Participant has had ≤2 COPD exacerbations requiring hospitalization in the past year.
Main Exclusion Criteria
Participants meeting any of the following criteria will be excluded from the study:
- Participant has an active uncontrolled medical condition
- Participant has a diagnosis of current asthma
- Participant has primary diagnosis of bronchiectasis, primary ciliary dyskinesia, allergic bronchopulmonary aspergillosis, or CF.
- Participant has had a COPD exacerbation in the 6 weeks prior to Visit 1
- Participant has active lung infection
- Participant has received any vaccine within 7 days prior to Day 1.
- Participant is taking a protein therapeutic for control of COPD or asthma: eg, dupilumab, tezepelumab, benralizumab, mepolizumab, omalizumab.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
AER-01-002 is a Phase 2a study being conducted to determine if inhaled fexlamose is an effective and safe treatment for adults with moderate to severe COPD.
Study will compare active drug to placebo.
- Conditions
- COPD
- Being tested
- Flexlamose, Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlexlamoseDrug
Fexlamose solution via nebulizer for 28 days
PlaceboDrug
Placebo solution via nebulizer for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Fexlamose | Experimental | Fexlamose solution once daily via nebulizer for 28 days Receives: Drug: Flexlamose |
| Placebo | Placebo comparator | Placebo solution once daily via nebulizer for 28 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1
Change from baseline in prebronchodilator FEV1 at Week 4
Measured: 4 weeks
Secondary outcomes (5)
Incidence of AEs (including SAEs and AESIs) throughout the study
Incidence of treatment related AEs (including SAEs and AESIs) throughout the study as assessed by CTCAE v4.0
Measured: 4 weeks
Change from baseline in CT mucus plug segment score at Week 4
Change from baseline in CT mucus plug segment score (0-20) at Week 4
Measured: 4 weeks
Change from baseline in E-RS:COPD score at Week 4
Change from baseline in E-RS:COPD score (0-40) at Week 4
Measured: 4 weeks
Change from baseline in prebronchodilator FVC at Week 4
Change from baseline in prebronchodilator forced vital capacity (FVC) at Week 4
Measured: 4 weeks
Change from baseline in SpO2 at Week 4
Change from baseline in oxygen saturation (SpO2) at Week 4
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study startDec 2024 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aer Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06731959
- Sponsor's protocol ID
- AER-01-002
- Acronym
- AER-01-002
- Status last verified
- Dec 2024
- First submitted
- 20 Nov 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06731959
- Acronym / sponsor ID
- AER-01-002 / AER-01-002
- Conditions
- COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aer TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Dec 2024 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
AER-01-002 is a Phase 2a study being conducted to determine if inhaled fexlamose is an effective and safe treatment for adults with moderate to severe COPD.
Study will compare active drug to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fexlamose | Experimental | Drug: FlexlamoseFexlamose solution once daily via nebulizer for 28 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo solution once daily via nebulizer for 28 days |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlexlamoseFexlamose solution via nebulizer for 28 days | Drug | Fexlamose |
| PlaceboPlacebo solution via nebulizer for 28 days | Drug | Placebo |
Primary outcome
FEV1
Time frame: 4 weeks
Change from baseline in prebronchodilator FEV1 at Week 4
5 secondary outcomes
Incidence of AEs (including SAEs and AESIs) throughout the study
Time frame: 4 weeks
Change from baseline in CT mucus plug segment score at Week 4
Time frame: 4 weeks
Change from baseline in E-RS:COPD score at Week 4
Time frame: 4 weeks
Change from baseline in prebronchodilator FVC at Week 4
Time frame: 4 weeks
Change from baseline in SpO2 at Week 4
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Flexlamose in people with COPD, run by Aer Therapeutics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jordan Low (4256239331, jordan.low@aertherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEV1 (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.