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

NCT07548827 | Not Yet Recruiting

• 1 other identifier: MTU-EC-IM-0-287/68
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 2

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.

Conditions

Asthma

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  The beginning of the study

Study Arms (1)

Asthma

Adults with asthma aged 18 years or older

Other: Spirometry; Other: Global Initiative for Asthma (GINA); Other: Asthma Control Test (ACT)

Interventions

Spirometry OTHER

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

Asthma

Global Initiative for Asthma (GINA) OTHER

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

Asthma

Asthma Control Test (ACT) OTHER

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

Asthma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Asthma
• Age 18 years or older

You may not qualify if:

• Inability to perform spirometry test

Sponsors & Collaborators

• Thammasat University: lead

Study Sites (2)

Narongkorn Saiphoklang

Pathum Thani, 12120, Thailand

Location

Narongkorn Saiphoklang

Pathum Thani, 12120, Thailand

Location

Related Publications (5)

• Sriprasart T, Saiphoklang N, Kawamatawong T, Boonsawat W, Mitthamsiri W, Chirakalwasan N, Chiewchalermsri C, Athipongarporn A, Kamalaporn H, Kornthatchapong K, Kulpraneet M, Sompornrattanaphan M, Oer-Areemitr N, Rerkpattanapipat T, Silairatana S, Thawanaphong S, Gaensan T, Jirakran K, Poachanukoon O. Allergic rhinitis and other comorbidities associated with asthma control in Thailand. Front Med (Lausanne). 2024 Jan 11;10:1308390. doi: 10.3389/fmed.2023.1308390. eCollection 2023.

  PMID: 38274465 RESULT

• Leblanc A, Botelho C, Coimbra A, da Silva JP, de Castro ED, Cernadas JR. Assessment of asthma control: clinical, functional and inflammatory aspects. Eur Ann Allergy Clin Immunol. 2013 May;45(3):90-6.

  PMID: 23862398 RESULT

• Olaguibel JM, Quirce S, Julia B, Fernandez C, Fortuna AM, Molina J, Plaza V; MAGIC Study Group. Measurement of asthma control according to Global Initiative for Asthma guidelines: a comparison with the Asthma Control Questionnaire. Respir Res. 2012 Jun 22;13(1):50. doi: 10.1186/1465-9921-13-50.

  PMID: 22726416 RESULT

• Nathan RA, Sorkness CA, Kosinski M, Schatz M, Li JT, Marcus P, Murray JJ, Pendergraft TB. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004 Jan;113(1):59-65. doi: 10.1016/j.jaci.2003.09.008.

  PMID: 14713908 RESULT

• Niyatiwatchanchai N, Chaiwong W, Pothirat C. The validity and reliability of the Thai version of the asthma control test. Asian Pac J Allergy Immunol. 2024 Mar;42(1):24-29. doi: 10.12932/AP-130820-0940.

  PMID: 33386787 RESULT

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Narongkorn Saiphoklang, MD

CONTACT

+6629269794; M_narongkorn@hotmail.com

Puri Chunekamrai, MD

CONTACT

+6629269701; book.chunekamrai@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 23, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD and documents will be available for sharing immediately after publication for a period of 2 years.

Locations

TH (2)