- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07351916
Remission in Adults With Mild-to-moderate Asthma in Thailand
The goal of this observational study is to determine the prevalence of remission among adults with mild-to-moderate 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 a questionnaire on asthma symptoms and undergo pulmonary function testing and a blood test once.
Study Overview
Status
Conditions
Detailed Description
This study is a cross-sectional study. Thai patients aged 18 years or older with mild-to-moderate 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).
GINA and ACT are questionnaires used to assess the level of asthma control.
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: Sirashat Hanvivattanakul, MD
- Phone Number: +6629269701
- Email: boss32_@hotmail.com
Study Locations
-
-
-
Pathum Thani, Thailand, 12120
- Recruiting
- Faculty of Medicine, Thammasat University
-
Principal Investigator:
- Narongkorn Saiphoklang, MD
-
Contact:
- Sirashat Hanvivattanakul, MD
- Phone Number: +6629269701
- Email: boss32_@hotmail.com
-
Contact:
- Narongkorn Saiphoklang, MD
- Phone Number: 029269794
- Email: M_narongkorn@hotmail.com
-
-
Changwat Pathum Thani
-
Pathum Thani, Changwat 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:
- Sirashat Hanvivattanakul, MD
- Phone Number: +6629269794
- Email: boss32_@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- mild-to-moderate 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 |
|---|---|
|
Mild-to-moderate asthma
Patients aged 18 years or older with mild-to-moderate asthma. Mild asthma refers to asthma patients who experience symptoms <3 times per week, have preserved lung function (FEV₁ or PEF >80% of predicted), and whose symptoms can be adequately controlled with low-dose inhaled corticosteroids (low-dose ICS) alone, without the need for long-acting bronchodilators or other controller medications. Moderate asthma refers to asthma patients who have symptoms >4-5 days per week or experience nocturnal asthma symptoms >1 per week, and who require treatment with medium-dose inhaled corticosteroids (medium-dose ICS) or low-dose ICS in combination with a long-acting β₂-agonist (low-dose ICS/LABA) to achieve symptom control and prevent exacerbations. |
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 mild-to-moderate asthma remission
Time Frame: An average of 1 year
|
Prevalence rate of mild-to-moderate asthma remission (%)
|
An average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Asthma control in patients with mild-to-moderate asthma
Time Frame: At baseline and at 12 months
|
Rate of patients with well-controlled asthma.
Well-controlled asthma is defined as an Asthma Control Test (ACT) score of 20 or higher.
|
At baseline and at 12 months
|
|
Airway obstruction in patients with mild-to-moderate asthma
Time Frame: At baseline and at 12 months
|
Airway obstruction is assessed using FEV1/FVC ratio on spirometry.
|
At baseline and at 12 months
|
|
Severity of aiway obstruction in patients with mild-to-moderate asthma
Time Frame: At baseline and at 12 months
|
The severity of aiway obstruction is assessed using FEV1 % predicted on spirometry.
|
At baseline and at 12 months
|
|
Eosinophil airway inflammation in patients with mild-to-moderate asthma
Time Frame: At baseline and at 12 months
|
Eosinophil airway inflammation is assessed using blood eosinophil count (cells/µL).
|
At baseline and at 12 months
|
|
Type 2 airway inflammation in patients with mild-to-moderate asthma
Time Frame: At baseline and at 12 months
|
Type 2 airway inflammation is assessed using fractional exhaled nitric oxide (FeNO, ppb).
|
At baseline and at 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Narongkorn Saiphoklang, MD, Thammasat University Faculty of Medicine
Publications and helpful links
General Publications
- 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.
- 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.
- Ishizuka M, Sugimoto N, Kobayashi K, Takeshita Y, Imoto S, Koizumi Y, Togashi Y, Tanaka Y, Nagata M, Hattori S, Uehara Y, Suzuki Y, Toyota H, Ishii S, Nagase H. Clinical remission of mild-to-moderate asthma: Rates, contributing factors, and stability. J Allergy Clin Immunol Glob. 2025 Jan 30;4(2):100431. doi: 10.1016/j.jacig.2025.100431. eCollection 2025 May.
- Chiewchalermsri C, Kanjanawasee D, Saiphoklang N, Chirakalwasan N, Sriprasart T, Senavonge A, Sanguanwong N, Kamalaporn H, Athipongarporn A, Hachai S, Boonsawat W, Brannan JD, Song WJ, Ruxrungtham K, Poachanukoon O. Asthma remission: A path to cure? Asian Pac J Allergy Immunol. 2025 Jun;43(2):135-150. doi: 10.12932/AP-240525-2082.
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
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity, Immediate
- Hypersensitivity
- Asthma
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Surveys and Questionnaires
Other Study ID Numbers
- MTU-EC-IM-0-282/68
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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