Evaluating the Methacholine Choline Provocation Test for Diagnosing Asthma
A Study on the Diagnostic Value of the Methacholine Choline Provocation Test in the Asthmatic Population
The First Affiliated Hospital of Guangzhou Medical University · NCT05870436
This study is testing a breathing test called the Methacholine Choline Provocation Test to see if it can accurately diagnose asthma in people who might have it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1100 (estimated) |
| Ages | 5 Years and up |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Guangzhou Medical University (other) |
| Locations | 6 sites (Beijing, Beijing and 5 other locations) |
| Trial ID | NCT05870436 on ClinicalTrials.gov |
What this trial studies
This multicenter observational study aims to assess the diagnostic value and safety of the Methacholine Choline Provocation Test in patients suspected of having asthma. The study is divided into two stages: the first stage involves patients who have not been previously diagnosed with asthma, where the test's sensitivity, specificity, and reliability will be evaluated based on forced expiratory volume measurements. The second stage includes all patients clinically evaluated for bronchial provocation testing to further validate the test's diagnostic capabilities and establish cutoff values for asthma diagnosis.
Who should consider this trial
Good fit: Ideal candidates are individuals with suspected asthma who have not been previously diagnosed and have a baseline lung function (FEV1) of 60% or greater.
Not a fit: Patients with severe asthma attacks requiring mechanical ventilation in the last three months or those with significant respiratory diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of asthma diagnoses, leading to better-targeted treatments for patients.
How similar studies have performed: Other studies have shown promising results with similar bronchial provocation tests, indicating that this approach has been validated in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Exclusion Criteria: * 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.)
Where this trial is running
Beijing, Beijing and 5 other locations
- Beijing Chao-yang Hospital, Capital Medical University — Beijing, Beijing, China (NOT_YET_RECRUITING)
- Songshan General Hospital — Chongqing, Chongqing, China (NOT_YET_RECRUITING)
- The First Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (RECRUITING)
- Henan Provincial People's Hospital — Zhengzhou, Henan, China (NOT_YET_RECRUITING)
- Tongji Hospital，Tongji Medical College of Hust — Wuhan, Hubei, China (NOT_YET_RECRUITING)
- West China Hospital of Sichuan University — Chengdu, Sichaun, China (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: yi Gao, PhD — The First Hospital of Guangzhou Medical University
- Study coordinator: jingping Zheng
- Email: jpzhenggy@163.com
- Phone: 18928868238
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Asthma, asthma diagnosis, Methacholine Choline Provocation Test