A Study to Investigate Using Inhaled Fexlamose to Treat Adult Participants Who Have Moderate to Severe COPD

Phase 2

Not yet recruiting

• Conditions: COPD
• Interventions: Drug: Flexlamose; Drug: Placebo

• Registration Number: NCT06731959
• Lead Sponsor: Aer Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-20
• Status Verified: 2024-12
• Study Start: 2024-12
• Study First Submitted QC: 2024-12-09
• Last Update Submitted: 2024-12-09
• Study First Posted: 2024-12-13
• Last Update Posted: 2024-12-13
• Primary Completion: 2025-11
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fexlamose	Flexlamose	Fexlamose solution once daily via nebulizer for 28 days
Placebo	Placebo	Placebo solution once daily via nebulizer for 28 days

Primary Outcome Measures

Name	Time	Method
FEV1	4 weeks	Change from baseline in prebronchodilator FEV1 at Week 4

Secondary Outcome Measures

Name	Time	Method
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
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