Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-28 @ 11:34 AM
Study NCT ID:
NCT05888350
Status:
UNKNOWN
Last Update Posted:
2023-07-11
First Post:
2023-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers for Predicting the Response to Inhaled Corticosteroid in Patients With Chronic Cough.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003371', 'term': 'Cough'}, {'id': 'D000096822', 'term': 'Chronic Cough'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001507', 'term': 'Beclomethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013258', 'term': 'Steroids, Chlorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'a multi-center, randomized, double-blind, placebo-controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 520}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-07-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-10', 'studyFirstSubmitDate': '2023-03-27', 'studyFirstSubmitQcDate': '2023-06-02', 'lastUpdatePostDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The AUC of blood eosinophils, FeNO and total IgE in predicting the response to inhaled corticosteroid in patients with chronic cough.', 'timeFrame': 'the 4th week', 'description': 'The area under the receiver operating curve (AUC) of blood eosinophils in predicting the response to inhaled corticosteroid in patients with chronic cough.\n\nThe area under the receiver operating curve (AUC) of FeNO in predicting the response to inhaled corticosteroid in patients with chronic cough.\n\nThe area under the receiver operating curve (AUC) of total IgE in predicting the response to inhaled corticosteroid in patients with chronic cough.'}, {'measure': 'The optimal cut-off value of blood eosinophils in cells/μL-1 in predicting the response to inhaled corticosteroid in patients with chronic cough.', 'timeFrame': 'the 4th week', 'description': 'The optimal cut-off value of blood eosinophils in cells/μL-1 in predicting the response to inhaled corticosteroid in patients with chronic cough.'}, {'measure': 'The optimal cut-off value of FeNO in pbb in kU/L in predicting the response to inhaled corticosteroid in patients with chronic cough.', 'timeFrame': 'the 4th week', 'description': 'The optimal cut-off value of FeNO in pbb in predicting the response to inhaled corticosteroid in patients with chronic cough.'}, {'measure': 'The optimal cut-off value of total IgE in kU/L in predicting the response to inhaled corticosteroid in patients with chronic cough.', 'timeFrame': 'the 4th week', 'description': 'The optimal cut-off value of total IgE in kU/L in predicting the response to inhaled corticosteroid in patients with chronic cough.'}, {'measure': 'The sensitivity and specificity in percentage of blood eosinophils, FeNO and total IgE in predicting the response to inhaled corticosteroid in patients with chronic cough.', 'timeFrame': 'the 4th week', 'description': 'The sensitivity and specificity in percentage of blood eosinophils in predicting the response to inhaled corticosteroid in patients with chronic cough.\n\nThe sensitivity and specificity in percentage of FeNO in predicting the response to inhaled corticosteroid in patients with chronic cough.\n\nThe sensitivity and specificity in percentage of total IgE in predicting the response to inhaled corticosteroid in patients with chronic cough.'}], 'secondaryOutcomes': [{'measure': 'Clinical characteristics of responders and non-responders', 'timeFrame': 'baseline', 'description': 'Clinical characteristics including gender, age and cough duration would be registered in a specific case report form in baseline.'}, {'measure': 'LCQ change from baseline to the 4th week', 'timeFrame': 'the 4th week', 'description': 'Leicester Cough Questionnaire （LCQ）aims to access the life quality of patients wtih chronic cough, ranging from 19 to 133. Higher scores mean a better outcome.'}, {'measure': 'Cough VAS change from baseline to the 4th week', 'timeFrame': 'the 4th week', 'description': 'Cough visual analogue scale (VAS) aims to access the severity of cough, ranging from 0 to 100mm. Higher scores mean a worse outcome.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic cough', 'biomarkers'], 'conditions': ['Cough']}, 'descriptionModule': {'briefSummary': 'To investigate the value of blood eosinophils, FeNO and total IgE in predicting the response to inhaled corticosteroid in patients with chronic cough.', 'detailedDescription': "Chronic cough is a frequent complaint in respiratory specialists clinic. CVA, UACS, EB, GERC and AC are common causes of chronic cough, among whom, CVA, EB and AC can be classified as corticosteroid responsive cough.\n\nTo recognize the eosinophilic airway inflammation and assess the response of inhaled corticosteroid, induced sputum analysis is the most widely used examination but not all the subjects can provide an suitable sample of sputum for measurements and it's time-consuming.\n\nRecently, blood eosinophils, FeNO and total IgE were detected to be biomarkers of eosinophilic airway inflammation for asthmatics. However, whether can they predict the response to corticosteroid in chronic cough remains uncertain.\n\nThe present prospective, multi-center, randomized placebo-controlled study aims to explore the value of blood eosinophils, FeNO and total IgE in predicting the response to inhaled corticosteroid in patients with chronic cough."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: 18-70 years;\n2. Coughing lasting ≥ 8 weeks；\n3. No abnormality in chest imaging in the past 3 months (or there is abnormality but the investigator judges it not the cause of chronic cough)；\n4. FEV1% pred\\>70%；FEV1/FVC\\>70%；\n5. VAS≥30 in the past 48 hours;\n6. Non-smokers or patients smoked less than 10 pack-years;\n7. Candidates voluntarily participate in and abide by the relevant regulations of the study, can cooperate with corresponding inspections, follow the follow-up plan, and voluntarily sign written informed consent.\n\nExclusion Criteria:\n\n1. Patients received inhaled or oral corticosteroids or leukotriene receptor antagonist in previous 4 weeks;\n2. Patients with history of upper respiratory tract infection in the past 8 weeks;\n3. Patients taking angiotensin-converting enzyme inhibitors in previous 8 weeks;\n4. Female subjects who are pregnant, breast-feeding or risk of becoming pregnant during the study;\n5. Combined with a definite history of pulmonary diseases such as bronchiectasis, pulmonary interstitial disease, and pulmonary hypertension. Combined with other serious diseases (such as cardiovascular system diseases, metabolic system diseases, immune system diseases, nervous system diseases, etc.) that may affect the normal process of this study;\n6. Participating in other drug clinical trial projects.'}, 'identificationModule': {'nctId': 'NCT05888350', 'acronym': 'CC-ICS', 'briefTitle': 'Biomarkers for Predicting the Response to Inhaled Corticosteroid in Patients With Chronic Cough.', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Guangzhou Medical University'}, 'officialTitle': 'The Value of FeNO, Blood Eosinophils and TIgE in Predicting the Response to Corticosteroid in Patients With Chronic Cough', 'orgStudyIdInfo': {'id': 'CC-ICS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Foster treatment group', 'description': 'Participant inhales Foster (Inhaled Beclometasone Dipropionate and Formoterol Inhalation Aerosol) 1 puff bid for 4 weeks.', 'interventionNames': ['Drug: Beclometasone Dipropionate and Formoterol Inhalation Aerosol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo controlled group', 'description': 'Participant inhales matched placebo 1 puff bid for 4 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Beclometasone Dipropionate and Formoterol Inhalation Aerosol', 'type': 'DRUG', 'description': 'Inhaled Foster (Beclometasone Dipropionate and Formoterol Inhalation Aerosol) , 1puff, BID, 4weeks', 'armGroupLabels': ['Foster treatment group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Inhaled Placebo, 1puff, BID, 4weeks', 'armGroupLabels': ['Placebo controlled group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '520120', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Kefang Lai, phD', 'role': 'CONTACT', 'email': 'klai@163.com', 'phone': '8156-6841', 'phoneExt': '020'}], 'overallOfficials': [{'name': 'Kefang Lai, phD', 'role': 'STUDY_CHAIR', 'affiliation': 'The First Affiliated Hospital of Guangzhou Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': "Huizhou Third People's Hospital", 'class': 'UNKNOWN'}, {'name': 'Guangdong Provincial Hospital of Traditional Chinese Medicine', 'class': 'OTHER'}, {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, {'name': "Shenzhen People's Hospital", 'class': 'OTHER'}, {'name': 'SSL Central Hospital of Dongguan City', 'class': 'UNKNOWN'}, {'name': 'China-Japan Friendship Hospital', 'class': 'OTHER'}, {'name': 'Beijing Chao Yang Hospital', 'class': 'OTHER'}, {'name': 'Zunyi Medical College', 'class': 'OTHER'}, {'name': "Henan Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Henan University of Traditional Chinese Medicine', 'class': 'OTHER'}, {'name': 'Second Hospital of Jilin University', 'class': 'OTHER'}, {'name': "Inner Mongolia People's Hospital", 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Shanxi Medical University', 'class': 'OTHER'}, {'name': 'Ruijin Hospital', 'class': 'OTHER'}, {'name': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, {'name': 'Tongji Hospital', 'class': 'OTHER'}, {'name': 'First Hospital of China Medical University', 'class': 'OTHER'}, {'name': 'Chongqing Songshan Hospital', 'class': 'UNKNOWN'}, {'name': "The First People's Hospital of Yunnan", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Kefang Lai', 'investigatorAffiliation': 'The First Affiliated Hospital of Guangzhou Medical University'}}}}