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To evaluate the efficacy and safety of biological agents in patients with allergic bronchopulmonary aspergillosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation group: on the basis of the original standard drug treatment, combined with biological ag |
| ||
| The control group only received standard drug treatment (oral glucocorticoids with or without oral a | The standard medical regimen was oral prednisone (0.5mg/Kg/ day for 4 weeks, 0.25mg/Kg/ day for 4 weeks, followed by 0.125mg/Kg/ day for 4 weeks, followed by a reduction of 5mg every 2 weeks until discontinuation) with or without oral voriconazole (200mg bid, 1 hour before or after meals). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biologic Agent | Drug | On the basis of the original standard drug treatment, biological agents were combined. All patients received at least 4 months of the same biologic agent, as recommended by the GINA2025 guidelines and assessed for response. It can be administered simultaneously with standard medical therapy or as maintenance therapy for 4 months on standard medical therapy. The previous treatment for bronchial asthma was maintained, including inhaled corticosteroids + long-acting β-receptor agonists, leukotriene receptor antagonists, etc. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of exacerbations (annual exacerbation rate) | Acute exacerbations include acute exacerbation of allergic bronchopulmonary aspergillosis, acute exacerbation/attack of asthma, and acute exacerbation/bronchiectasis of infection. Acute exacerbation of allergic bronchopulmonary aspergillosis: in patients who have been diagnosed with allergic bronchopulmonary aspergillosis, persistent (>14 days) clinical deterioration or worsening of imaging findings, accompanied by an increase in total serum IgE of >50% from the last recorded value in the stable period, with no other cause of deterioration. Acute asthma exacerbation/exacerbation: worsening of respiratory symptoms for at least 48 hours without evidence of immunological or radiographic worsening of allergic bronchopulmonary aspergillosis; Acute exacerbation of infectious/bronchiectasis: clinical worsening for at least 48 hours, including cough, dyspnea, changes in sputum volume or texture, sputum purulence, fatigue, malaising, fever, or hemoptysis, without immunological or imaging worse | 1 year and 2years |
| Measure | Description | Time Frame |
|---|---|---|
| 8-week treatment response rate | 8 weeks | |
| Number of hospitalizations due to acute exacerbations of allergic bronchopulmonary aspergillosis | 2 years | |
| The time to the first exacerbation |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with allergic bronchopulmonary aspergillosis included patients with newly diagnosed allergic bronchopulmonary aspergillosis and severe asthma, patients with refractory allergic bronchopulmonary aspergillosis, and patients with treatment-dependent allergic bronchopulmonary aspergillosis.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qian Qi, Dr. | Contact | +86 13706380314 | qiqianqlh@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, China | Recruiting | Jinan | Shandong | 250014 |
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| ID | Term |
|---|---|
| D001229 | Aspergillosis, Allergic Bronchopulmonary |
| D055744 | Invasive Pulmonary Aspergillosis |
| ID | Term |
|---|---|
| D055732 | Pulmonary Aspergillosis |
| D001228 | Aspergillosis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D001685 | Biological Factors |
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Serum, plasma, sputum, bronchoalveolar lavage fluid, stool, urine
|
| 2 years |
| The number of times achieved remission | 2 years |
| Daily oral glucocorticoid use rate/average daily oral glucocorticoid dose/cumulative oral glucocorticoid dose | 2 years |
| Proportion of patients who remain in remission after glucocorticoids are stopped | 2 years |
| The use of antifungal drugs | 2 years |
| asthma control test(ACT) | 2 years |
| Serum total IgE | 2 years |
| All-cause mortality | 2 years |
| Aspergillus fumigatus sIgE | 2 years |
| Aspergillus fumigatus sIgG | 2 years |
| peripheral blood eosinophil count | 2 years |
| Results of exhaled nitric oxide test | 2 years |
| China |
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| D007239 |
| Infections |
| D008172 | Lung Diseases, Fungal |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000072742 | Invasive Fungal Infections |