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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Fexlamose solution via nebulizer for 28 days
Placebo solution via nebulizer for 28 days
FEV1
Change from baseline in prebronchodilator FEV1 at Week 4
Time frame: 4 weeks
Incidence of AEs (including SAEs and AESIs) throughout the study
Incidence of treatment related AEs (including SAEs and AESIs) throughout the study as assessed by CTCAE v4.0
Time frame: 4 weeks
Change from baseline in CT mucus plug segment score at Week 4
Change from baseline in CT mucus plug segment score (0-20) at Week 4
Time frame: 4 weeks
Change from baseline in E-RS:COPD score at Week 4
Change from baseline in E-RS:COPD score (0-40) at Week 4
Time frame: 4 weeks
Change from baseline in prebronchodilator FVC at Week 4
Change from baseline in prebronchodilator forced vital capacity (FVC) at Week 4
Time frame: 4 weeks
Change from baseline in SpO2 at Week 4
Change from baseline in oxygen saturation (SpO2) at Week 4
Time frame: 4 weeks
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