Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 9:23 AM
Study NCT ID:
NCT07328035
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-13
First Post:
2025-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Remission in Adults With Severe Asthma in Thailand
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}], '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'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D013147', 'term': 'Spirometry'}, {'id': 'D000089142', 'term': 'Fractional Exhaled Nitric Oxide Testing'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D001944', 'term': 'Breath Tests'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 230}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-11', 'studyFirstSubmitDate': '2025-12-26', 'studyFirstSubmitQcDate': '2025-12-26', 'lastUpdatePostDateStruct': {'date': '2026-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence rate of severe asthma remission', 'timeFrame': 'The beginning of the study', 'description': 'Prevalence rate of remission in adults with severe asthma'}], 'secondaryOutcomes': [{'measure': 'Association of clinical characteristics with severe asthma remission', 'timeFrame': 'The beginning of the study', 'description': 'The association between severe asthma remission and the following variables will be evaluated:\n\n1. Asthma symptom control; Asthma Control Test (ACT) score (range 5-25)\n2. Exacerbation history; Number of asthma exacerbations requiring systemic corticosteroids in the previous 12 months\n3. Oral corticosteroid use; Daily oral corticosteroid use (yes/no) and cumulative dose (mg/year)\n4. Asthma duration; Years since asthma diagnosis'}, {'measure': 'Association of lung function with severe asthma remission', 'timeFrame': 'The beginning of the study', 'description': 'The association between severe asthma remission (binary outcome: remission vs. non-remission) and pulmonary function assessed using spirometry (FEV1 % predicted and FEV1/FVC ratio).'}, {'measure': 'Association of inflammatory biomarkers with severe asthma remission', 'timeFrame': 'The beginning of the study', 'description': 'The association between severe asthma remission (binary outcome: remission vs. non-remission) and inflammatory biomarkers assessed using blood eosinophil count (cells/µL) and fractional exhaled nitric oxide (FeNO) (parts per billion, ppb).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['asthma', 'remission', 'Thailand', 'severe', 'FeNO', 'blood eosinophil count'], 'conditions': ['Severe Asthma', 'Asthma Control Level']}, 'referencesModule': {'references': [{'pmid': '37857423', 'type': 'RESULT', 'citation': 'McDowell PJ, McDowell R, Busby J, Eastwood MC, Patel PH, Jackson DJ, Mansur A, Patel M, Burhan H, Doe S, Chaudhuri R, Gore R, Dodd JW, Subramanian D, Brown T, Heaney LG; UK Severe Asthma Registry. Clinical remission in severe asthma with biologic therapy: an analysis from the UK Severe Asthma Registry. Eur Respir J. 2023 Dec 14;62(6):2300819. doi: 10.1183/13993003.00819-2023. Print 2023 Dec.'}, {'pmid': '33220516', 'type': 'RESULT', 'citation': 'Tupper OD, Hakansson KEJ, Ulrik CS. Remission and Changes in Severity Over 30 Years in an Adult Asthma Cohort. J Allergy Clin Immunol Pract. 2021 Apr;9(4):1595-1603.e5. doi: 10.1016/j.jaip.2020.11.013. Epub 2020 Nov 19.'}, {'pmid': '39659738', 'type': 'RESULT', 'citation': 'Chipps BE, Lugogo N, Carr W, Zhou W, Patel A, Carstens DD, Trudo F, Ambrose CS. On-treatment clinical remission of severe asthma with real-world longer-term biologic use. J Allergy Clin Immunol Glob. 2024 Oct 30;4(1):100365. doi: 10.1016/j.jacig.2024.100365. eCollection 2025 Feb.'}, {'pmid': '38701495', 'type': 'RESULT', 'citation': 'Perez-de-Llano L, Scelo G, Tran TN, Le TT, Fageras M, Cosio BG, Peters M, Pfeffer PE, Al-Ahmad M, Al-Lehebi RO, Altraja A, Bergeron C, Bjermer LH, Bjerrum AS, Bulathsinhala L, Busby J, Cano Rosales DJ, Canonica GW, Carter VA, Charriot J, Christoff GC, Denton EJ, Dorscheid DR, Fernandez Sanchez MJ, Fonseca JA, Gibson PG, Goh CYY, Heaney LG, Heffler E, Hew M, Iwanaga T, Katial R, Koh MS, Kuna P, Larenas-Linnemann DES, Lehtimaki L, Mahboub B, Martin N, Matsumoto H, Menzies-Gow AN, Papadopoulos NG, Popov TA, Porsbjerg CM, Patel P, Rhee CK, Sadatsafavi M, Taille C, Torres-Duque CA, Tsai MJ, Ulrik CS, Upham JW, von Bulow A, Wang E, Wechsler ME, Price DB. Exploring Definitions and Predictors of Severe Asthma Clinical Remission after Biologic Treatment in Adults. Am J Respir Crit Care Med. 2024 Oct 1;210(7):869-880. doi: 10.1164/rccm.202311-2192OC.'}, {'pmid': '37925144', 'type': 'RESULT', 'citation': 'Hansen S, Baastrup Sondergaard M, von Bulow A, Bjerrum AS, Schmid J, Rasmussen LM, Johnsen CR, Ingebrigtsen T, Hakansson KEJ, Johansson SL, Bisgaard M, Assing KD, Hilberg O, Ulrik C, Porsbjerg C. Clinical Response and Remission in Patients With Severe Asthma Treated With Biologic Therapies. Chest. 2024 Feb;165(2):253-266. doi: 10.1016/j.chest.2023.10.046. Epub 2023 Nov 3.'}, {'pmid': '17360725', 'type': 'RESULT', 'citation': 'Holm M, Omenaas E, Gislason T, Svanes C, Jogi R, Norrman E, Janson C, Toren K; RHINE Study Group. Remission of asthma: a prospective longitudinal study from northern Europe (RHINE study). Eur Respir J. 2007 Jul;30(1):62-5. doi: 10.1183/09031936.00121705. Epub 2007 Mar 14.'}, {'pmid': '33263024', 'type': 'RESULT', 'citation': 'Almqvist L, Ronmark E, Stridsman C, Backman H, Lindberg A, Lundback B, Hedman L. Remission of adult-onset asthma is rare: a 15-year follow-up study. ERJ Open Res. 2020 Nov 23;6(4):00620-2020. doi: 10.1183/23120541.00620-2020. eCollection 2020 Oct.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to determine the prevalence of remission among adults with severe asthma, as well as the factors associated with remission in Thailand.\n\nThe main question the study aims to answer is:\n\nWhat is the prevalence of remission among adults with severe asthma in Thailand? Participants will complete questionnaires on asthma symptoms and undergo pulmonary function testing and a blood test once.', 'detailedDescription': 'This study is a cross-sectional study. Thai patients aged 18 years or older with severe asthma are included in the study. Participants will complete two questionnaires about asthma control: the Global Initiative for Asthma (GINA) and the Asthma Control Test (ACT), and will perform spirometry, a fractional exhaled nitric oxide (FeNO) test, and blood eosinophil counts (BEC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Thai patients aged 18 years or older with severe asthma are included in the study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* severe asthma\n* age 18 years or older\n\nExclusion Criteria:\n\n* inability to perform spirometry or fractional exhaled nitric oxide (FeNO) test'}, 'identificationModule': {'nctId': 'NCT07328035', 'briefTitle': 'Remission in Adults With Severe Asthma in Thailand', 'organization': {'class': 'OTHER', 'fullName': 'Thammasat University'}, 'officialTitle': 'Remission in Adults With Severe Asthma in Thailand', 'orgStudyIdInfo': {'id': 'MTU-EC-IM-0-283/68'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Severe asthma', 'description': 'Asthma that requires treatment with high-dose inhaled corticosteroids plus a second controller, or requires systemic corticosteroids for ≥50% of the previous year to prevent it from becoming uncontrolled, or remains uncontrolled despite this therapy.', 'interventionNames': ['Other: Global Initiative for Asthma (GINA) and Asthma Control Test (ACT) questionnaires', 'Diagnostic Test: Spirometry', 'Diagnostic Test: Fractional exhaled nitric oxide (FeNO) test', 'Diagnostic Test: Blood eosinophil count (BEC)']}], 'interventions': [{'name': 'Global Initiative for Asthma (GINA) and Asthma Control Test (ACT) questionnaires', 'type': 'OTHER', 'description': 'GINA and ACT are questionnaires used to assess the level of asthma control.', 'armGroupLabels': ['Severe asthma']}, {'name': 'Spirometry', 'type': 'DIAGNOSTIC_TEST', 'description': 'Spirometry is a tool used to assess pulmonary function.', 'armGroupLabels': ['Severe asthma']}, {'name': 'Fractional exhaled nitric oxide (FeNO) test', 'type': 'DIAGNOSTIC_TEST', 'description': 'FeNO is a tool used to assess eosinophilic airway inflammation and asthma remission.', 'armGroupLabels': ['Severe asthma']}, {'name': 'Blood eosinophil count (BEC)', 'type': 'DIAGNOSTIC_TEST', 'description': 'BEC is a tool used to assess eosinophilic inflammation and asthma remission.', 'armGroupLabels': ['Severe asthma']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Narongkorn Saiphoklang, MD', 'role': 'CONTACT', 'email': 'M_narongkorn@hotmail.com', 'phone': '+6629269794'}, {'name': 'Pacharaporn Tangsathapornpong, MD', 'role': 'CONTACT', 'email': 'pacharaporn.kaimook@gmail.com', 'phone': '+6629269701'}], 'overallOfficials': [{'name': 'Narongkorn Saiphoklang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thammasat University Faculty of Medicine'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'IPD and documents will be available for sharing immediately after publication for a period of 2 years.', 'ipdSharing': 'YES', 'description': 'IPD and documents'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thammasat University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Narongkorn Saiphoklang, MD', 'investigatorAffiliation': 'Thammasat University'}}}}