Real-World Effectiveness of Depemokimab in Allergic Bronchopulmonary Aspergillosis With Severe Eosinophilic Asthma

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorQianfoshan Hospital

About this trial

An open-label study will evaluate effects of Depemokimab in the treatment of severe eosinophilic asthma in patients with allergic bronchopulmonary aspergillosis

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female and Male patients aged 18-75 years

Diagnosis of Allergic Bronchopulmonary Aspergillosis (according to the ISHAM Working Group Diagnostic Criteria)

Severe asthma requiring treatment with high dose ICS plus a long acting beta-agonist (LABA) or long-acting muscarinic antagonists (LAMA)), or maintenance OCS (daily or every other day OCS requirement in order to maintain asthma control)

Disqualifiers

History of allergy or hypersensitivity reaction to Depemokimab or any of its components.

Currently pregnant, breastfeeding, or lactating women.

Concurrent enrollment in another interventional or post-authorization safety study, unless it is observational.

Trial design

Design model

Single group

Treatments tested in this trial

  • Depemokimab

    Drug

    100 mg (1mL) Subcutaneous Solution

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Depemokimab treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

Lung Function (FEV1)

The FEV1 change from baseline to End of Treatment

Time frame
26 weeks

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: