A Study to Investigate Using Inhaled Fexlamose to Treat Adult Participants Who Have Moderate to Severe COPD
NCT ID: NCT06731959
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
100 participants
INTERVENTIONAL
2024-12-31
2026-01-31
Brief Summary
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Study will compare active drug to placebo.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Fexlamose
Fexlamose solution once daily via nebulizer for 28 days
Flexlamose
Fexlamose solution via nebulizer for 28 days
Placebo
Placebo solution once daily via nebulizer for 28 days
Placebo
Placebo solution via nebulizer for 28 days
Interventions
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Flexlamose
Fexlamose solution via nebulizer for 28 days
Placebo
Placebo solution via nebulizer for 28 days
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
40 Years
80 Years
ALL
No
Sponsors
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Aer Therapeutics
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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AER-01-002
Identifier Type: -
Identifier Source: org_study_id