AsthmaNCT05870436
A Study on the Diagnostic Value of the Methacholine Choline Provocation Test in the Asthmatic Population
An observational study of Asthma, run by jingping Zheng at 6 sites in China.
Trial summary
This study was a multicenter, open, observational study and was divided into two stages; Stage I study includes patients with suspected asthma to observe the diagnostic value and safety of Methacholine Choline Provocation Test. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Methacholine Choline Provocation Test
- How many people
- 1,100 participants
- Where
- 6 sitesChina
- Study dates
- 19 May 2023to Jun 2025
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Stage I study: patients with one or more symptoms such as wheezing, shortness of breath, cough and chest tightness, clinically evaluated as suspected asthma but not previously diagnosed as asthma and requiring bronchial provocation test, such as patients with suspected asthma without obstructive pulmonary function changes, patients with suspected cough variant asthma (CVA) in chronic cough, patients with recurrent chest tightness episodes suspected of chest tightness variant asthma (CTVA), etc. Stage II study: bronchial provocation test is required after clinical evaluation, including patients with suspected asthma, asthma, allergic rhinitis, chronic obstructive pulmonary disease, and chronic bronchitis.
Who may be able to join
- Stage I study:
- clinically evaluated as suspected asthma but have not been previously diagnosed as asthma and require a bronchial provocation test
- Basal lung function FEV1 ≥ 60%
- Meet the requirements for conducting bronchial excitation tests and pulmonary ventilation examinations
- Not currently suffering from or accompanied by other respiratory diseases, including allergic rhinitis, chronic obstructive pulmonary disease, chronic bronchitis, etc.
- Stage II study:
- Basal lung function FEV1 ≥ 60%
- Meet the requirements for conducting bronchial excitation tests and pulmonary ventilation examinations
Who cannot join
- Have had a fatal asthma attack, or have required mechanical ventilation for an asthma attack within the last 3 months
- Definite hypersensitivity reaction to inhaled stimulants or salbutamol or unexplained urticaria
- Severe impairment of basal pulmonary ventilation (FEV1 < 60% of expected value %, or < 1 L in adults)
- Poor cooperation with basal pulmonary function tests that do not meet quality control requirements
- Other conditions that make a bronchial provocation test or pulmonary ventilation function test inappropriate (e.g., recent presence of severe cardiovascular disease, seizures, uncontrolled hypertension, etc.)
Trial locations and contacts
6 sites in 1 country.
yi Gao contact
6 sites in 1 country
China6 sites, 6 recruiting
- Not yet recruiting
Beijing Chao-yang Hospital, Capital Medical University
Beijing, Beijing Municipality
yong Lu, Master
- Not yet recruiting
West China Hospital of Sichuan University
Chengdu, Sichaun
binmiao Liang, PhD
- Not yet recruiting
Songshan General Hospital
Chongqing, Chongqing Municipality
qianli Ma, PhD
- Recruiting
The First Hospital of Guangzhou Medical University
Guangzhou, Guangdong
jingping Zheng
- Not yet recruiting
Tongji Hospital，Tongji Medical College of Hust
Wuhan, Hubei
tao Wang, PhD
- Not yet recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan
xiaoju Zhang, PhD
About this study
This study was a multicenter, open, observational study and was divided into two stages; Stage I study includes patients with suspected asthma to observe the diagnostic value and safety of Methacholine Choline Provocation Test. All patients clinically evaluated for bronchial provocation testing were included in the stage II study to further validate the diagnostic value and cutoff value of the methacholine choline provocation test.
Read the detailed description
This study was a multicenter, open, observational study. The study was divided into two stages; the first stage of the study included a population with suspected asthma and performed a bronchial provocation test, and cumulative provocation dose when forced expiratory volume in one second (FEV1) fell by 20% (PD20 ) data were recorded. Subjects with positive excitation were treated as asthma for 3 months and treatment was considered effective to confirm the diagnosis of asthma. Sensitivity, specificity, and reliability of the methacholine choline provocation test were calculated, and cutoff values were obtained by exploratory analysis based on PD20 values. All patients clinically evaluated for bronchial provocation testing were included in the stage II study to further validate the diagnostic value and cutoff value of the methacholine choline provocation test.
- Conditions
- Asthma
- Being tested
- Methacholine Choline Provocation Test
- Keywords
- asthma diagnosis, Methacholine Choline Provocation Test
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methacholine Choline Provocation TestDiagnostic test
Perform methacholine choline provocation test according to the protocol
| Study group | Role | What they receive |
|---|---|---|
| Positive group | The group that conducted the Methacholine Choline Provocation Test with Positive result Receives: Diagnostic Test: Methacholine Choline Provocation Test | |
| Negative group | The group that conducted the Methacholine Choline Provocation Test with negative result Receives: Diagnostic Test: Methacholine Choline Provocation Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, specificity
The sensitivity, specificity of the test were calculated by the results of the test and whether the patient was finally diagnosed with asthma by performing the methacholine choline provocation test in patients suspected of having asthma
Measured: Baseline up to 3 months
Secondary outcomes (1)
The incidence, severity of adverse events
Safety
Measured: Baseline up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start19 May 2023
- Primary completionJan 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- jingping Zheng
- Sponsor type
- University, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Responsible party
- Sponsor-investigator, jingping Zheng, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- yi Gao, PhD, Principal investigator, The First Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870436
- Sponsor's protocol ID
- SX20221101
- Status last verified
- May 2023
- First submitted
- 11 May 2023
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Diagnostic Value of the Methacholine Choline Provocation Test in the Asthmatic Population
- ClinicalTrials.gov ID
- NCT05870436
- Acronym / sponsor ID
- SX20221101
- Conditions
- Asthma
- Keywords
- asthma diagnosis, Methacholine Choline Provocation Test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- jingping ZhengUniversity, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Study start
- 19 May 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 23 May 2023 (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.
This study was a multicenter, open, observational study and was divided into two stages; Stage I study includes patients with suspected asthma to observe the diagnostic value and safety of Methacholine Choline Provocation Test. All patients clinically evaluated for bronchial provocation testing were included in the stage II study to further validate the diagnostic value and cutoff value of the methacholine choline provocation test.
Detailed description
This study was a multicenter, open, observational study. The study was divided into two stages; the first stage of the study included a population with suspected asthma and performed a bronchial provocation test, and cumulative provocation dose when forced expiratory volume in one second (FEV1) fell by 20% (PD20 ) data were recorded. Subjects with positive excitation were treated as asthma for 3 months and treatment was considered effective to confirm the diagnosis of asthma. Sensitivity, specificity, and reliability of the methacholine choline provocation test were calculated, and cutoff values were obtained by exploratory analysis based on PD20 values. All patients clinically evaluated for bronchial provocation testing were included in the stage II study to further validate the diagnostic value and cutoff value of the methacholine choline provocation test.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive group | – | Diagnostic Test: Methacholine Choline Provocation TestThe group that conducted the Methacholine Choline Provocation Test with Positive result |
| Negative group | – | Diagnostic Test: Methacholine Choline Provocation TestThe group that conducted the Methacholine Choline Provocation Test with negative result |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Stage I study: patients with one or more symptoms such as wheezing, shortness of breath, cough and chest tightness, clinically evaluated as suspected asthma but not previously diagnosed as asthma and requiring bronchial provocation test, such as patients with suspected asthma without obstructive pulmonary function changes, patients with suspected cough variant asthma (CVA) in chronic cough, patients with recurrent chest tightness episodes suspected of chest tightness variant asthma (CTVA), etc. Stage II study: bronchial provocation test is required after clinical evaluation, including patients with suspected asthma, asthma, allergic rhinitis, chronic obstructive pulmonary disease, and chronic bronchitis.
Key inclusion criteria (8 listed)
- clinically evaluated as suspected asthma but have not been previously diagnosed as asthma and require a bronchial provocation test
- Basal lung function FEV1 ≥ 60%
- Meet the requirements for conducting bronchial excitation tests and pulmonary ventilation examinations
- Not currently suffering from or accompanied by other respiratory diseases, including allergic rhinitis, chronic obstructive pulmonary disease, chronic bronchitis, etc.
- Basal lung function FEV1 ≥ 60%
Key exclusion criteria (5 listed)
- Have had a fatal asthma attack, or have required mechanical ventilation for an asthma attack within the last 3 months
- Definite hypersensitivity reaction to inhaled stimulants or salbutamol or unexplained urticaria
- Severe impairment of basal pulmonary ventilation (FEV1 < 60% of expected value %, or < 1 L in adults)
- Poor cooperation with basal pulmonary function tests that do not meet quality control requirements
- Other conditions that make a bronchial provocation test or pulmonary ventilation function test inappropriate (e.g., recent presence of severe cardiovascular disease, seizures, uncontrolled hypertension, etc.)
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 |
|---|---|---|
| Methacholine Choline Provocation TestPerform methacholine choline provocation test according to the protocol | Diagnostic test | Negative group, Positive group |
Primary outcome
Sensitivity, specificity
Time frame: Baseline up to 3 months
The sensitivity, specificity of the test were calculated by the results of the test and whether the patient was finally diagnosed with asthma by performing the methacholine choline provocation test in patients suspected of having asthma
1 secondary outcome
The incidence, severity of adverse events
Time frame: Baseline up to 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Individual participant dataSharing planned: No
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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.
yi Gao contact
yi Gao, PhD principal investigator
The First Hospital of Guangzhou Medical University
6 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 jingping Zheng at 6 sites in China.
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 8 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: status not confirmed, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jingping Zheng (18928868238, jpzhenggy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity, specificity (time frame: Baseline up to 3 months). 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 23 May 2023; AzTrials last refreshed its copy on 6 Nov 2026.