Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-27 @ 11:25 PM
Study NCT ID:
NCT06895460
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-05
First Post:
2025-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial on the Treatment of Bronchial Asthma With Budesonide Formoterol Combined With Immune Modulators (Staphylococcus and Neisseria Tablets)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069502', 'term': 'Budesonide, Formoterol Fumarate Drug Combination'}, {'id': 'D000276', 'term': 'Adjuvants, Immunologic'}], 'ancestors': [{'id': 'D000068759', 'term': 'Formoterol Fumarate'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D019819', 'term': 'Budesonide'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D007155', 'term': 'Immunologic Factors'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 198}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-03', 'studyFirstSubmitDate': '2025-02-27', 'studyFirstSubmitQcDate': '2025-03-19', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The overall asthma control rate at 12 weeks of treatment', 'timeFrame': 'week 12', 'description': 'The overall control rate = (number of well-controlled cases + number of partially controlled cases) / total number of cases × 100%'}], 'secondaryOutcomes': [{'measure': 'The overall asthma control rate at 24 weeks of treatment', 'timeFrame': 'week 24', 'description': 'The overall control rate = (number of well-controlled cases + number of partially controlled cases) / total number of cases × 100%'}, {'measure': 'Number of acute asthma exacerbations', 'timeFrame': 'Month 1, Month 2, Month 3, Month 4, Month 5, Month 6'}, {'measure': 'Changes in Asthma Control Test (ACT) scores', 'timeFrame': 'Month 1, Month 2, Month 3, Month 4, Month 5, Month 6', 'description': 'The minimum and maximum scores of the Asthma Control Test are 5 and 25 points respectively. The higher the ACT score, the better the asthma control.'}, {'measure': 'Changes in lung function indicators compared to baseline', 'timeFrame': 'Month 3, Month 6', 'description': 'Changes in PEF'}, {'measure': 'Five-point Asthma Quality of Life Scoring', 'timeFrame': 'Month 3, Month 6', 'description': "The minimum and maximum total scores of the 5-point asthma quality of life assessment are 35 and 175 points respectively. The higher the score, the better the patient's quality of life."}, {'measure': 'Adverse events (AEs)', 'timeFrame': 'Month 1, Month 2, Month 3, Month 4, Month 5, Month 6'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bronchial Asthma']}, 'descriptionModule': {'briefSummary': 'A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial on the Treatment of Bronchial Asthma with Budesonide Formoterol Combined with Immune Modulators (Staphylococcus and Neisseria Tablets)', 'detailedDescription': 'This study is a randomized, double-blind, placebo-controlled, multicenter clinical trial. A total of 198 participants with bronchial asthma are planned to be enrolled and randomized in a 1:1 ratio to the experimental group and the control group. The experimental group will receive Budesonide Formoterol Powder for Inhalation plus immune modulators (Staphylococcus and Neisseria Tablets), while the control group will receive Budesonide Formoterol Powder for Inhalation plus placebo. The treatment period is 3 months for both groups, followed by a 3-month follow-up after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥ 14 years, male or female;\n2. Confirmed diagnosis of asthma at least 6 months prior to screening;\n3. Patients with uncontrolled asthma (according to the 2024 GINA guidelines-asthma control level classification criteria, patients with partially controlled and uncontrolled asthma);\n4. Within the past 6 months, at least one of the following positive test results for lung function:\n\n * Positive bronchodilator test with an increase in FEV1 of ≥12%, and an absolute increase in FEV1 of ≥200 ml;\n * Positive bronchial provocation test or exercise challenge test;\n * Peak expiratory flow (PEF) variability over 2 weeks with a daily variation rate of ≥20% or a weekly average variation rate of ≥10%;\n * Significant improvement in lung function after 4 weeks of asthma treatment, with an increase in FEV1 of ≥12%, an absolute increase in FEV1 of ≥200 ml, or an improvement in PEF of ≥20%;\n5. Before the first administration of the study drug, the patient has good function of major organs and no contraindications to ICS + LABA treatment;\n6. The participant (or their legal representative) must sign and date the informed consent form, indicating their understanding of the study's purpose and the procedures involved, and their willingness to participate in the study.\n\nExclusion Criteria:\n\n1. Patients with a history of severe asthma (according to the definition in the Guidelines for the Prevention and Treatment of Bronchial Asthma (2024 Edition));\n2. Patients in the acute exacerbation phase who may require intravenous/oral corticosteroids;\n3. Patients with rheumatology and immunology conditions;\n4. Atypical asthma or comorbidities such as pulmonary tuberculosis, chronic obstructive pulmonary disease, bronchiectasis, pulmonary embolism, severe respiratory failure, or other respiratory system diseases;\n5. Individuals with significant diseases other than bronchial asthma. Significant diseases are defined as conditions that, in the investigator's judgment, may place the participant at risk or affect the study results, such as severe cardiovascular, cerebrovascular, hepatic, renal, hematologic diseases, malignancies, psychiatric disorders, immune system diseases, or pulmonary organic functional impairments;\n6. Individuals allergic to the study drug or corticosteroids;\n7. Participation in another clinical trial within 30 days prior to screening or currently ongoing;\n8. Use of immune modulators (including thymosin, thymopeptides, interferon, transfer factor, Bacillus Calmette-Guérin polysaccharides, any type of bacterial extracts, such as Biostim, bacterial lysate capsules) within 30 days prior to the use of the study drug or during the study period;\n9. Women who are currently pregnant or breastfeeding, or women of childbearing potential who cannot use contraception during the study period;\n10. The participant is deemed unsuitable for study observation by the investigator."}, 'identificationModule': {'nctId': 'NCT06895460', 'briefTitle': 'A Trial on the Treatment of Bronchial Asthma With Budesonide Formoterol Combined With Immune Modulators (Staphylococcus and Neisseria Tablets)', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial on the Treatment of Bronchial Asthma With Budesonide Formoterol Combined With Immune Modulators (Staphylococcus and Neisseria Tablets)', 'orgStudyIdInfo': {'id': 'QL-BA-QIP-1001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Budesonide Formoterol combined with placebo', 'interventionNames': ['Drug: Budesonide Formoterol', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Budesonide Formoterol Combined with Immune Modulators (Staphylococcus and Neisseria Tablets)', 'interventionNames': ['Drug: Budesonide Formoterol', 'Drug: Immune Modulators (Staphylococcus and Neisseria Tablets)']}], 'interventions': [{'name': 'Budesonide Formoterol', 'type': 'DRUG', 'description': 'Investigator Selection', 'armGroupLabels': ['Budesonide Formoterol Combined with Immune Modulators (Staphylococcus and Neisseria Tablets)', 'Budesonide Formoterol combined with placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo: 0.3 mg/tablet, 4 tablets per dose, 3 times per day, for a course of 3 months', 'armGroupLabels': ['Budesonide Formoterol combined with placebo']}, {'name': 'Immune Modulators (Staphylococcus and Neisseria Tablets)', 'type': 'DRUG', 'description': 'Staphylococcus and Neisseria Tablets: 0.3 mg/tablet, 4 tablets per dose, 3 times per day, for a course of 3 months', 'armGroupLabels': ['Budesonide Formoterol Combined with Immune Modulators (Staphylococcus and Neisseria Tablets)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'Xin Yao Chief physician', 'role': 'CONTACT', 'email': 'xyao1998@126.com', 'phone': '18651608881'}], 'facility': 'The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Xin Yao, Chief physician', 'role': 'CONTACT', 'email': 'xyao1998@126.com', 'phone': '+8618651608881'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}