GINA-P and ACT-P Scores for Assessing Asthma Control

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07548827

Enrollment

144

Registered

2026-04-23

Start date

2026-05-01

Completion date

2026-12-31

Last updated

2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

asthma, asthma control, pulmonary function, bronchodilator response, Asthma Control Test, Global Initiative for Asthma, ACT-P, GINA-P

Brief summary

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.

Detailed description

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).

Interventions

OTHERSpirometry

Spirometry with bronchodilator testing will be performed to assess FEV1, the FEV1/FVC ratio, and bronchodilator response.

OTHERGlobal Initiative for Asthma (GINA)

GINA is a questionnaire used to assess the level of asthma control.

OTHERAsthma Control Test (ACT)

ACT is a questionnaire used to assess the level of asthma control.

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Asthma * Age 18 years or older

Exclusion criteria

* Inability to perform spirometry test

Design outcomes

Primary

Measure	Time frame	Description
Accuracy of GINA-P scores in assessing asthma control levels	The beginning of the study	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.
Accuracy of ACT-P scores in assessing asthma control levels	The beginning of the study	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.

Countries

Thailand

Contacts

CONTACTNarongkorn Saiphoklang, MD

M_narongkorn@hotmail.com+6629269794

CONTACTPuri Chunekamrai, MD

book.chunekamrai@gmail.com+6629269701

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 24, 2026