Chronic Obstructive Pulmonary DiseaseNCT06346678
Accuracy of Accuhaler Tester, Ellipta Tester and Turbutester in Patients With Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease, run by Thammasat University at 1 site in Thailand.
Trial summary
The goal of this observational study is to investigate the accuracy of Accuhaler tester, Ellipta tester and Turbutester in patients with chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Accuhaler tester
- How many people
- 82 participants
- Where
- 1 siteThailand
- Study dates
- 1 Apr 2024to 15 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients aged 40 years or older who are confirmed diagnosis by spirometry (post-bronchodilator FEV1/FVC <0.7) and smoking history 10 pack-years or more.
Who may be able to join
- COPD diagnosis with confirmed by post-bronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) <0.7
- Age 40 years or older
- Smoking history 10 pack-years or more
Who cannot join
- COPD exacerbation within 3 months
- Oral or intravenous corticosteroid treatment within 6 weeks
- Inability to perform assessment of peak inspiratory flow rate
- Asthma
- Tracheostomy, invasive or noninvasive mechanical ventilation
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Narongkorn Saiphoklang
Pathum Thani, Changwat Pathum Thani, 12120
About this study
The goal of this observational study is to investigate the accuracy of Accuhaler tester, Ellipta tester and Turbutester in patients with chronic obstructive pulmonary disease (COPD). The main question it aims to answer is:
- Do Accuhaler tester, Ellipta tester, and Turbutester demonstrate comparable accuracy to the In-check DIAL for assessing inspiratory inhalation force in COPD patients?
Read the detailed description
This study is a cross-sectional study. COPD patients aged 40 years or older will be included. Peak inspiratory flow rate (PIFR) will be assessed using In-check DIAL as the standard tool. PIFR will be tested in each patient using Accuhaler tester, Ellipta tester and Turbutester.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Accuhaler tester
- Keywords
- Chronic obstructive pulmonary disease, COPD, Accuhaler tester, Ellipta tester, Turbutester, Peak inspiratory flow rate
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accuhaler testerOther
Also called Ellipta tester, Turbutester
Patients will perform testing with Accuhaler tester, Ellipta tester and Turbutester.
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Accuhaler tester
Percentage
Measured: At day 1 of the study
Accuracy of Ellipta tester
Percentage
Measured: At day 1 of the study
Accuracy of Turbutester
Percentage
Measured: At day 1 of the study
Secondary outcomes (2)
Prevalence of suboptimal peak inspiratory flow rate
Percentage
Measured: At day 1 of the study
Prevalence of insufficient peak inspiratory flow rate
Percentage
Measured: At day 1 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 posted4 Apr 2024
- Study start1 Apr 2024
- Primary completion31 Oct 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Narongkorn Saiphoklang, MD, Thammasat University
- Investigators
- Narongkorn Saiphoklang, MD, Principal investigator, Thammasat University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346678
- Sponsor's protocol ID
- MTU-EC-IM-0-016/67
- Status last verified
- Jan 2026
- First submitted
- 29 Mar 2024
- Last updated
- 2 Feb 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Accuhaler Tester, Ellipta Tester and Turbutester in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06346678
- Acronym / sponsor ID
- MTU-EC-IM-0-016/67
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic obstructive pulmonary disease, COPD, Accuhaler tester, Ellipta tester, Turbutester, Peak inspiratory flow rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 4 Apr 2024 (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 investigate the accuracy of Accuhaler tester, Ellipta tester and Turbutester in patients with chronic obstructive pulmonary disease (COPD). The main question it aims to answer is:
- Do Accuhaler tester, Ellipta tester, and Turbutester demonstrate comparable accuracy to the In-check DIAL for assessing inspiratory inhalation force in COPD patients?
Detailed description
This study is a cross-sectional study. COPD patients aged 40 years or older will be included. Peak inspiratory flow rate (PIFR) will be assessed using In-check DIAL as the standard tool. PIFR will be tested in each patient using Accuhaler tester, Ellipta tester and Turbutester.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients aged 40 years or older who are confirmed diagnosis by spirometry (post-bronchodilator FEV1/FVC <0.7) and smoking history 10 pack-years or more.
Key inclusion criteria (3 listed)
- COPD diagnosis with confirmed by post-bronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) <0.7
- Age 40 years or older
- Smoking history 10 pack-years or more
Key exclusion criteria (5 listed)
- COPD exacerbation within 3 months
- Oral or intravenous corticosteroid treatment within 6 weeks
- Inability to perform assessment of peak inspiratory flow rate
- Asthma
- Tracheostomy, invasive or noninvasive mechanical ventilation
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 |
|---|---|---|
| Accuhaler testerAlso: Ellipta tester, TurbutesterPatients will perform testing with Accuhaler tester, Ellipta tester and Turbutester. | Other | – |
Primary outcome
Accuracy of Accuhaler tester
Time frame: At day 1 of the study
Percentage
Accuracy of Ellipta tester
Time frame: At day 1 of the study
Percentage
Accuracy of Turbutester
Time frame: At day 1 of the study
Percentage
2 secondary outcomes
Prevalence of suboptimal peak inspiratory flow rate
Time frame: At day 1 of the study
Prevalence of insufficient peak inspiratory flow rate
Time frame: At day 1 of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- 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. This study is not recruiting at the moment.
Narongkorn Saiphoklang, MD principal investigator
Thammasat University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Thammasat University at 1 site 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Accuhaler tester (time frame: At day 1 of the study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2026.