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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

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523020-50-00
Acronym
AER-01-002
Enrollment
90
Registered
2026-01-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Brief summary

• Change from baseline in prebronchodilator FEV1 at Week 4

Detailed description

1. Change from baseline in CT MPSS at w 4, 2. Percentage of participants who have treatment related reduction of MPSS, 3. Change from baseline in SGRQ-C at w 4, 4. Percentage of participants with ≥4 unit decrease from baseline in SGRQ-C at w 4, 5. Change from baseline in prebronchodilator FVC at w 4, 6. Change from baseline in SpO2 at w 4, 7. Incidence of AEs throughout the study, 8. Hematology, biochemistry, and urinalysis parameters assessed throughout the study, 9. Incidence of GGO as detected by CT lung scan at w 4

Interventions

DRUGFexlamose
DRUGPlacebo inhalation solution is manufactured as a sterile
DRUGsingle-dose
DRUGpreservative-free aqueous solution.

Sponsors

Aer Therapeutics Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
• Change from baseline in prebronchodilator FEV1 at Week 4—

Secondary

MeasureTime frame
1. Change from baseline in CT MPSS at w 4, 2. Percentage of participants who have treatment related reduction of MPSS, 3. Change from baseline in SGRQ-C at w 4, 4. Percentage of participants with ≥4 unit decrease from baseline in SGRQ-C at w 4, 5. Change from baseline in prebronchodilator FVC at w 4, 6. Change from baseline in SpO2 at w 4, 7. Incidence of AEs throughout the study, 8. Hematology, biochemistry, and urinalysis parameters assessed throughout the study, 9. Incidence of GGO as detected by CT lung scan at w 4—

Countries

Bulgaria, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026