A Study to Investigate Using Inhaled Fexlamose to Treat Adult Participants Who Have Moderate to Severe COPD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Flexlamose, Placebo.
- Who it may be relevant to
- Registry conditions: COPD. Basic parameters: 40 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
- Drug Flexlamose
Fexlamose solution via nebulizer for 28 days - Drug Placebo
Placebo solution via nebulizer for 28 days
Primary outcome measures
- FEV1 [Time frame: 4 weeks]
Secondary outcome measures (5)
- 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]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06731959 · AER-01-002