A Study on the Diagnostic Value of the Methacholine Choline Provocation Test in the Asthmatic Population

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma
• Intervention / Treatment: Diagnostic test: 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 Type: Observational
• Enrollment (Anticipated): 1100

Contacts and Locations

• Study Contact: Name: jingping Zheng; Phone Number: 18928868238; Email: jpzhenggy@163.com
• Study Contact Backup: Name: yi Gao; Phone Number: 13560358322

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Not yet recruiting
      • Beijing Chao-Yang Hospital, Capital Medical University
      • Contact: yong Lu, Master
  • Chongqing
    • Chongqing, Chongqing, China
      • Not yet recruiting
      • Songshan General Hospital
      • Contact: qianli Ma, PhD
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • The First Hospital of Guangzhou Medical University
      • Contact: jingping Zheng
  • Henan
    • Zhengzhou, Henan, China
      • Not yet recruiting
      • Henan Provincial People's Hospital
      • Contact: Xiaoju Zhang, PhD
  • Hubei
    • Wuhan, Hubei, China
      • Not yet recruiting
      • Tongji Hospital,Tongji Medical college of Hust
      • Contact: tao Wang, PhD
  • Sichaun
    • Chengdu, Sichaun, China
      • Not yet recruiting
      • West China Hospital of Sichuan University
      • Contact: binmiao Liang, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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.)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Positive group; The group that conducted the Methacholine Choline Provocation Test with Positive result	Diagnostic test: Methacholine Choline Provocation Test; Perform methacholine choline provocation test according to the protocol
Negative group; The group that conducted the Methacholine Choline Provocation Test with negative result	Diagnostic test: Methacholine Choline Provocation Test; Perform methacholine choline provocation test according to the protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence, severity of adverse events	Safety	Baseline up to 1 week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PD20 cutoff value	PD20 cutoff values for asthma diagnosis by methacholine choline provocation test	through study completion, an average of 2 year

Collaborators and Investigators

• Sponsor: jingping Zheng
• Collaborators: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Investigators: Principal Investigator: yi Gao, PhD, The First Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2023
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): June 1, 2025

Study Registration Dates

• First Submitted: May 11, 2023
• First Submitted That Met QC Criteria: May 22, 2023
• First Posted (Actual): May 23, 2023

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: asthma diagnosis; Methacholine Choline Provocation Test
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Antimetabolites; Gastrointestinal Agents; Hypolipidemic Agents; Lipid Regulating Agents; Cholinergic Agonists; Respiratory System Agents; Nootropic Agents; Lipotropic Agents; Miotics; Parasympathomimetics; Bronchoconstrictor Agents; Muscarinic Agonists; Choline; Methacholine Chloride
• Other Study ID Numbers: SX20221101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No