An open-label study will evaluate effects of Depemokimab in the treatment of severe eosinophilic asthma in patients with allergic bronchopulmonary aspergillosis
Subjects who have been identified to have severe eosinophilic asthma with ABPA will be consented and enrolled in the study to receive Depemokimab injections (100 mg subcutaneous) administered every 6 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
100 mg (1mL) Subcutaneous Solution
Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, China
Jinan, Shandong, China
Number of steroid requiring exacerbations
Number of asthma exacerbations requiring the initiation of (or temporary increase in) systemic corticosteroids in severe eosinophilic asthma complicated by ABPA
Time frame: 26 weeks
Patient-Reported Quality of Life as assessed by Saint George Respiratory Questionnaire
The change from baseline score in Saint George Respiratory Questionnaire. The Saint George Respiratory Questionnaire (SGRQ) total score ranges from 0 to 100. Higher scores indicate a worse outcome (greater health impairment/poorer quality of life)
Time frame: 26 weeks
Asthma Control as assessed by Asthma Control Questionnaire 6
The change from baseline score in Asthma Control Questionnaire 6. ACQ-6 scores range from 0 to 6, where higher scores represent poorer asthma control. A score ≤0.75 indicates well-controlled asthma, while a score ≥1.5 indicates uncontrolled asthma.
Time frame: 26 weeks
Lung Function (FEV1)
The FEV1 change from baseline to End of Treatment
Time frame: 26 weeks
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