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

April 16, 2026 updated by: Narongkorn Saiphoklang, MD, Thammasat University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Estimated)

144

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Thai patients aged 18 years or older with asthma are included in the study.

Description

Inclusion Criteria:

  • Asthma
  • Age 18 years or older

Exclusion Criteria:

  • Inability to perform spirometry test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Asthma
Adults with asthma aged 18 years or older
Other: Spirometry
Spirometry with bronchodilator testing will be performed to assess FEV1, the FEV1/FVC ratio, and bronchodilator response.
Other: Global Initiative for Asthma (GINA)
GINA is a questionnaire used to assess the level of asthma control.
Other: Asthma Control Test (ACT)
ACT is a questionnaire used to assess the level of asthma control.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thammasat University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 16, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTU-EC-IM-0-287/68

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD and documents will be available for sharing immediately after publication for a period of 2 years.

IPD Sharing Time Frame

IPD and documents will be available for sharing immediately after publication for a period of 2 years.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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