COPD
Conditions
Brief 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.
Interventions
DRUGFlexlamose
Fexlamose solution via nebulizer for 28 days
DRUGPlacebo
Placebo solution via nebulizer for 28 days
Sponsors
Aer Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FEV1 | 4 weeks | Change from baseline in prebronchodilator FEV1 at Week 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of AEs (including SAEs and AESIs) throughout the study | 4 weeks | Incidence of treatment related AEs (including SAEs and AESIs) throughout the study as assessed by CTCAE v4.0 |
| Change from baseline in CT mucus plug segment score at Week 4 | 4 weeks | Change from baseline in CT mucus plug segment score (0-20) at Week 4 |
| Change from baseline in E-RS:COPD score at Week 4 | 4 weeks | Change from baseline in E-RS:COPD score (0-40) at Week 4 |
| Change from baseline in prebronchodilator FVC at Week 4 | 4 weeks | Change from baseline in prebronchodilator forced vital capacity (FVC) at Week 4 |
| Change from baseline in SpO2 at Week 4 | 4 weeks | Change from baseline in oxygen saturation (SpO2) at Week 4 |
Contacts
Primary ContactJordan Low
Outcome results
None listed