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Not yet recruiting NCT07548827

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

— Observational Asthma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Spirometry, Global Initiative for Asthma (GINA), Asthma Control Test (ACT).
Who it may be relevant to
Registry conditions: Asthma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

  • 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.

Primary outcome measures

  • Accuracy of GINA-P scores in assessing asthma control levels [Time frame: The beginning of the study]
  • Accuracy of ACT-P scores in assessing asthma control levels [Time frame: The beginning of the study]

Eligibility criteria

Inclusion criteria

  • Asthma
  • Age 18 years or older

Exclusion criteria

  • Inability to perform spirometry test

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Thailand · 2 centers
  • Narongkorn Saiphoklang — Pathum Thani
  • Narongkorn Saiphoklang — Pathum Thani

Publications

  • 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 (L PMID 38274465
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT07548827 · MTU-EC-IM-0-287/68

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗