ABPA, Allergic Bronchopulmonary Aspergillosis, Severe Asthma
Conditions
Keywords
ABPA, Tezepelumab
Brief summary
An open-label study will evaluate effects of Tezepelumab in the treatment of severe asthma in patients with allergic bronchopulmonary aspergillosis
Detailed description
Subjects who have been identified to have severe asthma with ABPA will be consented and enrolled in the study to receive Tezepelumab injections (210 mg subcutaneous) administered every 4 weeks.
Interventions
DRUGTezepelumab
210 mg (1.91 mL) Subcutaneous Solution
Sponsors
Qianfoshan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Female and Male patients aged 18-75 years inclusively at the time of Visit 1 with a physician diagnosis of Allergic Bronchopulmonary Aspergillosis has met the ISHAM Working Group Diagnostic Criteria for ABPA: Predisposing condition: Bronchial asthma Obligatory criteria (both should be present) Type I aspergillus skin test positive (immediate cutaneous hypersensitivity Aspergillus antigen) or elevated IgE level against Aspergillus fumigatus (Af) Aspergillus niger or Aspergillus flavus may be eligible provided antigen-specific IgE and IgG measurements are available for use. Elevated total IgE levels (\>1,000IU/mL)\* Other criteria (at least two of three) Presence of precipitating or IgG antibodies against Af in serum Radiographic pulmonary opacities consistent with ABPA Total eosinophil count \>500 cells/uL in steroid naïve patients (may be historical) (if the patient meets all other criteria, an IgE value \<1,000 IU/mL may be acceptable) Severe chronic asthma (for at least 12 months) requiring treatment with high dose ICS plus asthma controller prior to Visit 1 Other acceptable asthma controllers include long acting bronchodilators (e.g. a long acting beta-agonist (LABA) or long-acting muscarinic antagonists (LAMA)), a leukotriene inhibitor, theophylline preparations and/or maintenance OCS (daily or every other day OCS requirement in order to maintain asthma control Documented current treatment with high daily doses of ICS ( \>500ug of FP equivalent) plus at least one other asthma controller for at least 3 months prior to Visit 1 For ICS/LABA combination preparation, highest-strength maintenance doses approved in the U.S. will meet this criterion If the ICS and the other asthma controller therapies are given by separate inhalers, then the patient must be on a high daily ICS dose for 3 months prior to entering the study. History of at least 2 asthma exacerbations while on ICS plus another asthma controller (see inclusion criterion 2 for examples) that required treatment with systemic corticosteroids (IM, IV, or oral) in the 12 months prior to Visit 1. For patients receiving oral corticosteroids as a maintenance therapy, an exacerbation is defined as a temporary increase of their maintenance dose for a minimum of 3 days. Weight \> 40kg
Exclusion criteria
Clinically important pulmonary disease other than asthma with allergic bronchopulmonary aspergillosis (i.e., chronic obstructive pulmonary disease (COPD), cystic fibrosis, sarcoidosis, and pulmonary fibrosis). History of anaphylaxis to any biologic therapy. Known history of allergy or hypersensitivity reaction to tezepelumab 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of steroid requiring exacerbations | 26 weeks | Number of asthma exacerbations requiring the initiation of (or temporary increase in) systemic corticosteroids in severe asthma complicated by ABPA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Quality of Life as assessed by Saint George Respiratory Questionnaire | 26 weeks | 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) |
| Asthma Control as assessed by Asthma Control Questionnaire 6 | 26 weeks | 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. |
| Lung Function (FEV1) | 26 weeks | The FEV1 change from baseline to End of Treatment |
Countries
China
Contacts
CONTACTQian Qi
Outcome results
None listed