An observational study in Asthma, sponsored by Thammasat University. Not yet recruiting at 2 sites in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by Thammasat University · Observational
The goal of this observational study is to determine the accuracy of GINA-P and ACT-P scores in assessing asthma control levels among adults with asthma.
The main question the study aims to answer is:
How accurate are the GINA-P and ACT-P scores in assessing asthma control levels among adults with asthma? Participants will complete a questionnaire on asthma symptoms and undergo pulmonary function testing.
This study is a cross-sectional study. Thai patients aged 18 years or older with asthma will be included. Participants will complete two questionnaires assessing asthma control-the Global Initiative for Asthma (GINA) and the Asthma Control Test (ACT)-and will undergo pulmonary function using spirometry, fractional exhaled nitric oxide (FeNO) testing, and blood eosinophil count (BEC) measurement.
GINA and ACT are questionnaires used to assess the level of asthma control. GINA-P and ACT-P scores are new tools that incorporate pulmonary function parameters (FEV1 ≥ 80%, no bronchodilator response, and FEV1/FVC ratio > LLN). If these parameters meet the criteria, the "P" component is scored as zero (0); if any of these criteria are present, it is scored as one (1).
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's planned enrollment of 144 is close to the median of 158 across 1,250 observational studies indexed under Asthma.
Browse Asthma studies →Thammasat University is the lead sponsor of 85 studies on the registry; 16 are open to participants now.
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Thai patients aged 18 years or older with asthma are included in the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Adults with asthma aged 18 years or older
Other: Spirometry · Other: Global Initiative for Asthma (GINA) · Other: Asthma Control Test (ACT)
Spirometry with bronchodilator testing will be performed to assess FEV1, the FEV1/FVC ratio, and bronchodilator response.
GINA is a questionnaire used to assess the level of asthma control.
ACT is a questionnaire used to assess the level of asthma control.
Accuracy of GINA-P scores in assessing asthma control levels
The accuracy of GINA-P scores in assessing asthma control levels will be evaluated by comparing GINA-P scores with a reference standard of asthma control. Diagnostic performance will be assessed using sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall accuracy. The discriminative ability of GINA-P scores will be evaluated using receiver operating characteristic (ROC) curve analysis, and the area under the curve (AUC) will be calculated.
Time frame: The beginning of the study
Accuracy of ACT-P scores in assessing asthma control levels
The accuracy of ACT-P scores in assessing asthma control levels will be evaluated by comparing ACT-P scores with a reference standard of asthma control. Diagnostic performance will be assessed using sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall accuracy. The discriminative ability of ACT-P scores will be evaluated using receiver operating characteristic (ROC) curve analysis, and the area under the curve (AUC) will be calculated.
Time frame: The beginning of the study
Plan to share: Yes — IPD and documents will be available for sharing immediately after publication for a period of 2 years.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: IPD and documents will be available for sharing immediately after publication for a period of 2 years.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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