Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the efficacy and safety of bronchoscopic airway clearance and amphotericin B spraying in the treatment of allergic bronchopulmonary aspergillosis
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation group | The observation group was treated with standard drug therapy (oral glucocorticoids combined or not combined with oral antifungal drugs), combined with bronchoscopic airway clearance and amphotericin B spraying treatment |
| |
| Control group | Control group: The control group was treated with standard drug therapy (oral glucocorticoids with or without oral antifungal drugs). The previous treatment for bronchial asthma was maintained, including inhaled corticosteroids + long-acting β-receptor agonists, leukotriene receptor antagonists, etc. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The patients were treated with bronchoscopic airway clearance and amphotericin B spraying | Procedure | In addition to standard medical therapy (oral glucocorticoids with or without oral antifungal agents), bronchoscopic airway clearance and bronchoscopic spraying of amphotericin B (depending on the effectiveness of bronchoscopic mucus plug removal, At least one time of bronchoscopic airway clearance and amphotericin B spraying). The previous treatment for bronchial asthma was maintained, including inhaled corticosteroids + long-acting β-receptor agonists, leukotriene receptor antagonists, etc. |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic response rate after 4 months of treatment | Radiographic remission: defined as the removal of mucus plugs in the airway on radiographic examination | 4 months |
| Immunological remission rate after 4 months of treatment | Immunological remission: defined as at least a 50% decrease in total serum IgE from baseline | 4 months |
| The remission rate of clinical symptoms after 4 months of treatment | Clinical symptom relief: The semi-quantitative rating of clinical symptoms was evaluated using Likert scores with at least 50% improvement in symptoms | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of acute exacerbations within 1 year of drug withdrawal after 4 months of treatment | 1 year | |
| Number of acute exacerbations within 2 years after 4 months of treatment | 2 years | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients diagnosed with allergic bronchopulmonary aspergillosis included patients with newly diagnosed allergic bronchopulmonary aspergillosis and patients with acute exacerbation of allergic bronchopulmonary aspergillosis after drug withdrawal.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qian Qi, Dr. | Contact | +86 13706380314 | qiqianqlh@163.com |
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Serum, plasma, sputum, bronchoalveolar lavage fluid, urine, stool
|
| Treatment response rate at 8 weeks |
| 8 weeks |
| Number of hospitalizations due to acute exacerbations of allergic bronchopulmonary aspergillosis | 2 years |
| Time from discontinuation to first exacerbation | 2 years |
| After drug withdrawal, the number of patients who achieved treatment remission | The remission phase was defined as sustained (>6 months) clinical-radiologic improvement in the absence of (or discontinuation of) glucocorticoid therapy and the absence of an increase in total serum IgE of 50% or more from the last recorded value during the stable phase | 2 years |
| Quality of life score (AQLQ or mini-AQLQ) | 2 years |
| Serum total IgE | 2 years |
| All-cause mortality | 2 years |
| psychological Scale (Hospital Anxiety and Depression Scale, HADS) | 2 years |
| Aspergillus fumigatus sIgE | 2 years |
| China |
|
| ID | Term |
|---|---|
| D001229 | Aspergillosis, Allergic Bronchopulmonary |
| ID | Term |
|---|---|
| D055732 | Pulmonary Aspergillosis |
| D001228 | Aspergillosis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| 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 |
Not provided
Not provided