- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07328035
Remission in Adults With Severe Asthma in Thailand
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.
The main question the study aims to answer is:
What 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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Narongkorn Saiphoklang, MD
- Phone Number: +6629269794
- Email: M_narongkorn@hotmail.com
Study Contact Backup
- Name: Pacharaporn Tangsathapornpong, MD
- Phone Number: +6629269701
- Email: pacharaporn.kaimook@gmail.com
Study Locations
-
-
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Pathum Thani, Thailand, 12120
- Recruiting
- Narongkorn Saiphoklang
-
Contact:
- Narongkorn Saiphoklang, MD
- Phone Number: +6629269794
- Email: M_narongkorn@hotmail.com
-
Principal Investigator:
- Narongkorn Saiphoklang, MD
-
Contact:
- Pacharaporn Tangsathapornpong, MD
- Phone Number: +6629269701
- Email: pacharaporn.kaimook@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- severe asthma
- age 18 years or older
Exclusion Criteria:
- inability to perform spirometry or fractional exhaled nitric oxide (FeNO) test
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Severe asthma
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.
|
GINA and ACT are questionnaires used to assess the level of asthma control.
Spirometry is a tool used to assess pulmonary function.
FeNO is a tool used to assess eosinophilic airway inflammation and asthma remission.
BEC is a tool used to assess eosinophilic inflammation and asthma remission.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence rate of severe asthma remission
Time Frame: The beginning of the study
|
Prevalence rate of remission in adults with severe asthma
|
The beginning of the study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Association of clinical characteristics with severe asthma remission
Time Frame: The beginning of the study
|
The association between severe asthma remission and the following variables will be evaluated:
|
The beginning of the study
|
|
Association of lung function with severe asthma remission
Time Frame: The beginning of the study
|
The association between severe asthma remission (binary outcome: remission vs. non-remission) and pulmonary function assessed using spirometry (FEV1 % predicted and FEV1/FVC ratio).
|
The beginning of the study
|
|
Association of inflammatory biomarkers with severe asthma remission
Time Frame: The beginning of the study
|
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).
|
The beginning of the study
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Narongkorn Saiphoklang, Thammasat University Faculty of Medicine
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Immune System Diseases
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Lung Diseases
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity, Immediate
- Hypersensitivity
- Lymphatic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Hemic and Lymphatic Diseases
- Asthma
- Lymphoma, Follicular
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Diagnostic Techniques and Procedures
- Diagnosis
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Diagnostic Techniques, Respiratory System
- Respiratory Function Tests
- Breath Tests
- Surveys and Questionnaires
- Spirometry
- Fractional Exhaled Nitric Oxide Testing
Other Study ID Numbers
- MTU-EC-IM-0-283/68
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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