Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:20 AM
Study NCT ID:
NCT07362693
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-23
First Post:
2025-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Cohort Study of the Efficacy and Safety of Biologics in Patients With ABPA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001229', 'term': 'Aspergillosis, Allergic Bronchopulmonary'}, {'id': 'D055744', 'term': 'Invasive Pulmonary Aspergillosis'}], 'ancestors': [{'id': 'D055732', 'term': 'Pulmonary Aspergillosis'}, {'id': 'D001228', 'term': 'Aspergillosis'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008172', 'term': 'Lung Diseases, Fungal'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D000072742', 'term': 'Invasive Fungal Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum, plasma, sputum, bronchoalveolar lavage fluid, stool, urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-15', 'studyFirstSubmitDate': '2025-12-27', 'studyFirstSubmitQcDate': '2026-01-15', 'lastUpdatePostDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of exacerbations (annual exacerbation rate)', 'timeFrame': '1 year and 2years', 'description': 'Acute exacerbations include acute exacerbation of allergic bronchopulmonary aspergillosis, acute exacerbation/attack of asthma, and acute exacerbation/bronchiectasis of infection.\n\nAcute 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.\n\nAcute 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'}], 'secondaryOutcomes': [{'measure': '8-week treatment response rate', 'timeFrame': '8 weeks'}, {'measure': 'Number of hospitalizations due to acute exacerbations of allergic bronchopulmonary aspergillosis', 'timeFrame': '2 years'}, {'measure': 'The time to the first exacerbation', 'timeFrame': '2 years'}, {'measure': 'The number of times achieved remission', 'timeFrame': '2 years'}, {'measure': 'Daily oral glucocorticoid use rate/average daily oral glucocorticoid dose/cumulative oral glucocorticoid dose', 'timeFrame': '2 years'}, {'measure': 'Proportion of patients who remain in remission after glucocorticoids are stopped', 'timeFrame': '2 years'}, {'measure': 'The use of antifungal drugs', 'timeFrame': '2 years'}, {'measure': 'asthma control test(ACT)', 'timeFrame': '2 years'}, {'measure': 'Serum total IgE', 'timeFrame': '2 years'}, {'measure': 'All-cause mortality', 'timeFrame': '2 years'}, {'measure': 'Aspergillus fumigatus sIgE', 'timeFrame': '2 years'}, {'measure': 'Aspergillus fumigatus sIgG', 'timeFrame': '2 years'}, {'measure': 'peripheral blood eosinophil count', 'timeFrame': '2 years'}, {'measure': 'Results of exhaled nitric oxide test', 'timeFrame': '2 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['abpa', 'Allergic Bronchopulmonary Aspergillosis', 'Biologics'], 'conditions': ['ABPA', 'Biologics', 'Allergic Bronchopulmonary Aspergillosis (ABPA)', 'Cohort Study', 'Allergic Bronchopulmonary Aspergillosis', 'Efficacy and Safety']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of biological agents in patients with allergic bronchopulmonary aspergillosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Meet the diagnostic criteria of allergic bronchopulmonary aspergillosis, according to the ISHAM guidelines for the diagnosis and treatment of allergic bronchopulmonary aspergillosis (2024 revision).\n2. The underlying disease was bronchial asthma, and it was severe bronchial asthma.\n3. Have had an acute asthma attack in the past year. Acute exacerbation of asthma is defined as the sudden onset of wheezing, shortness of breath, cough, chest tightness and other symptoms beyond the definition of uncontrolled asthma, or the aggravation of the original symptoms, and is characterized by decreased expiratory flow, often induced by exposure to allergens, irritants or respiratory tract infection.\n4. Blood eosinophil count ≥150 cells /μL.\n5. Age ≥ 18 years old.\n\nExclusion Criteria:\n\n1. The underlying diseases were chronic obstructive pulmonary disease and bronchiectasis;\n2. Known allergic history to biological agents;\n3. Human immunodeficiency virus infection, active pulmonary tuberculosis or pulmonary malignant tumor;\n4. Complicated with other diseases requiring long-term systemic use of glucocorticoids or immunosuppressants (such as autoimmune diseases);\n5. Pregnant or lactating women;\n6. Currently participating in other interventional clinical research;\n7. Any other conditions considered by the investigator to preclude participation in the study (e.g., nonadherence, predicted survival \\<1 year, or severe mental illness that prevented cooperation).'}, 'identificationModule': {'nctId': 'NCT07362693', 'briefTitle': 'A Cohort Study of the Efficacy and Safety of Biologics in Patients With ABPA', 'organization': {'class': 'OTHER', 'fullName': 'Qianfoshan Hospital'}, 'officialTitle': 'A Prospective, Multicenter, Observational Cohort Study on the Efficacy and Safety of Biological Agents in Patients With Allergic Bronchopulmonary Aspergillosis', 'orgStudyIdInfo': {'id': 'ABPA-002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observation group: on the basis of the original standard drug treatment, combined with biological ag', 'interventionNames': ['Drug: Biologic Agent']}, {'label': 'The control group only received standard drug treatment (oral glucocorticoids with or without oral a', 'description': '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).'}], 'interventions': [{'name': 'Biologic Agent', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Observation group: on the basis of the original standard drug treatment, combined with biological ag']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250014', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'contacts': [{'name': 'Qian Qi, Dr.', 'role': 'CONTACT', 'email': 'qiqianqlh@163.com', 'phone': '+86 13706380314'}], 'facility': 'Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, China', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Qian Qi, Dr.', 'role': 'CONTACT', 'email': 'qiqianqlh@163.com', 'phone': '+86 13706380314'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qianfoshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Qian Qi', 'investigatorAffiliation': 'Qianfoshan Hospital'}}}}