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

Last updated: May 22, 2023
Sponsor: jingping Zheng
Overall Status: Active - Recruiting

Phase

N/A

Condition

Asthma

Treatment

Methacholine Choline Provocation Test

Clinical Study ID

NCT05870436
SX20221101
  • Ages > 5
  • All Genders

Study 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. 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: Stage I study:

  • clinically evaluated as suspected asthma but have not been previously diagnosed asasthma and require a bronchial provocation test
  • Basal lung function FEV1 ≥ 60%
  • Meet the requirements for conducting bronchial excitation tests and pulmonaryventilation examinations
  • Not currently suffering from or accompanied by other respiratory diseases, includingallergic 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 pulmonaryventilation examinations

Exclusion

Exclusion Criteria:

  • Have had a fatal asthma attack, or have required mechanical ventilation for an asthmaattack within the last 3 months
  • Definite hypersensitivity reaction to inhaled stimulants or salbutamol or unexplainedurticaria
  • 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 controlrequirements
  • Other conditions that make a bronchial provocation test or pulmonary ventilationfunction test inappropriate (e.g., recent presence of severe cardiovascular disease,seizures, uncontrolled hypertension, etc.)

Study Design

Total Participants: 1100
Treatment Group(s): 1
Primary Treatment: Methacholine Choline Provocation Test
Phase:
Study Start date:
May 19, 2023
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • Beijing Chao-yang Hospital, Capital Medical University

    Beijing, Beijing
    China

    Site Not Available

  • Songshan General Hospital

    Chongqing, Chongqing
    China

    Site Not Available

  • The First Hospital of Guangzhou Medical University

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • Henan Provincial People's Hospital

    Zhengzhou, Henan
    China

    Site Not Available

  • Tongji Hospital,Tongji Medical College of Hust

    Wuhan, Hubei
    China

    Site Not Available

  • West China Hospital of Sichuan University

    Chengdu, Sichaun
    China

    Site Not Available

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