AsthmaNCT07548827
GINA-P and ACT-P Scores for Assessing Asthma Control
An observational study of Asthma, run by Thammasat University at 2 sites in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Spirometry and Global Initiative for Asthma (GINA)
- How many people
- 144 participants
- Where
- 2 sitesThailand
- Study dates
- 1 May 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Thai patients aged 18 years or older with asthma are included in the study.
Who may be able to join
- Asthma
- Age 18 years or older
Who cannot join
- Inability to perform spirometry test
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand2 sites
Narongkorn Saiphoklang
Pathum Thani, 12120
Narongkorn Saiphoklang
Pathum Thani, 12120
Narongkorn Saiphoklang, MD, M_narongkorn@hotmail.com
Puri Chunekamrai, MD, +6629269701, book.chunekamrai@gmail.com
About this study
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.
Read the 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).
- Conditions
- Asthma
- Being tested
- Spirometry, Global Initiative for Asthma (GINA), Asthma Control Test (ACT)
- Keywords
- asthma, asthma control, pulmonary function, bronchodilator response, Asthma Control Test, Global Initiative for Asthma, ACT-P, GINA-P
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpirometryOther
Spirometry with bronchodilator testing will be performed to assess FEV1, the FEV1/FVC ratio, and bronchodilator response.
Global Initiative for Asthma (GINA)Other
GINA is a questionnaire used to assess the level of asthma control.
Asthma Control Test (ACT)Other
ACT is a questionnaire used to assess the level of asthma control.
| Study group | Role | What they receive |
|---|---|---|
| Asthma | Adults with asthma aged 18 years or older Receives: Other: Spirometry; Other: Global Initiative for Asthma (GINA); Other: Asthma Control Test (ACT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: The beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Narongkorn Saiphoklang, MD, Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548827
- Sponsor's protocol ID
- MTU-EC-IM-0-287/68
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD and documents will be available for sharing immediately after publication for a period of 2 years.
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 (Lausanne). 2024 Jan 11;10:1308390. doi: 10.3389/fmed.2023.1308390. eCollection 2023.
PubMed 38274465Leblanc 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.
PubMed 23862398Olaguibel 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.
PubMed 22726416Nathan 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.
PubMed 14713908Niyatiwatchanchai 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.
PubMed 33386787
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GINA-P and ACT-P Scores for Assessing Asthma Control
- ClinicalTrials.gov ID
- NCT07548827
- Acronym / sponsor ID
- MTU-EC-IM-0-287/68
- Conditions
- Asthma
- Keywords
- asthma, asthma control, pulmonary function, bronchodilator response, Asthma Control Test, Global Initiative for Asthma, ACT-P, GINA-P
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asthma | – | Other: Spirometry, Other: Global Initiative for Asthma (GINA), Other: Asthma Control Test (ACT)Adults with asthma aged 18 years or older |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Thai patients aged 18 years or older with asthma are included in the study.
Key inclusion criteria (2 listed)
- Asthma
- Age 18 years or older
Key exclusion criteria (1 listed)
- Inability to perform spirometry test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpirometrySpirometry with bronchodilator testing will be performed to assess FEV1, the FEV1/FVC ratio, and bronchodilator response. | Other | Asthma |
| Global Initiative for Asthma (GINA)GINA is a questionnaire used to assess the level of asthma control. | Other | Asthma |
| Asthma Control Test (ACT)ACT is a questionnaire used to assess the level of asthma control. | Other | Asthma |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Results publication: PubMed 38274465Sriprasart 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.
- Results publication: PubMed 23862398Leblanc 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.
- Results publication: PubMed 22726416Olaguibel 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.
- Results publication: PubMed 14713908Nathan 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.
- Results publication: PubMed 33386787Niyatiwatchanchai 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.
- Individual participant dataSharing planned: Yes. IPD and documents will be available for sharing immediately after publication for a period of 2 years.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Thammasat University at 2 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Narongkorn Saiphoklang, MD (+6629269794, M_narongkorn@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of GINA-P scores in assessing asthma control levels (time frame: The beginning of the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07548827, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.