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临床试验/NCT07548827
NCT07548827尚未招募不适用

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

Thammasat University1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2026年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
144
试验地点
1
主要终点
Accuracy of GINA-P scores in assessing asthma control levels

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years or older

排除标准

  • Inability to perform spirometry test

研究组 & 干预措施

Asthma

Adults with asthma aged 18 years or older

干预措施: Spirometry (Other)

Asthma

Adults with asthma aged 18 years or older

干预措施: Global Initiative for Asthma (GINA) (Other)

Asthma

Adults with asthma aged 18 years or older

干预措施: Asthma Control Test (ACT) (Other)

结局指标

主要结局

Accuracy of GINA-P scores in assessing asthma control levels

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Narongkorn Saiphoklang, MD

Associate Professor

Thammasat University

研究点 (1)

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