The Association of Transgelin-2, Metallothionein-2 and Ezrin With Asthma

NCT05496582 | Recruiting

• 1 other identifier: SHUTCM-0806
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

Asthma is one of the most common chronic respiratory diseases. Previous study found a series of differentially expressed genes and proteins (transgelin-2, metallothionein-2, ezrin) in asthmatic rat. The aim of the study is to investigate the changes and associations of these gene with asthma in human.

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

• Difference in gene expression of transgelin-2, metallothionein-2 and ezrin between controls and asthmatic patients

  PCR test of gene expression of transgelin-2, metallothionein-2 and ezrin between controls and asthmatic patients

  Two year

• Association of transgelin-2, metallothionein-2 and ezrin with asthma

  Correlation analysis between gene expressions of transgelin-2, metallothionein-2, ezrin and current asthmatic tests (pulmonary function, fractional exhaled nitric oxide,immunoglobulin E, serum eosinophil counts, interleukin-5, etc)

  Two year

Study Arms (2)

Asthma

Previously disgnosed asthma patients

Diagnostic Test: No intervention

Control

Healthy participants

Diagnostic Test: No intervention

Interventions

No intervention DIAGNOSTIC_TEST

No intervention

Asthma; Control

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with asthma or non-asthma

You may qualify if:

• Males or females, aged 14-75 years;
• Patients with a definite diagnosis of bronchial asthma;
• The diagnosis of asthma according to the Global Initiative for Asthma (GINA), with positive bronchodilator responsiveness (reversibility) test;
• Healthy volunteers without respiratory symptoms such as cough, wheezing, chest tightness or dyspnea;
• Agree with all procedures in this trial by signing a written informed consent form.

You may not qualify if:

• Patients with chronic obstructive pulmonary disease or other airway disease;
• Complicated with other severe primary diseases (including hypertension, cancer, hyperthyroidism, bronchiectasia, cardiac insufficiency) and conditions that would prevent participation in the trial or put the participant at risk;
• Women who are known to be pregnant or breastfeeding;
• Not willing to participate;
• Psychiatric history and neurological disorders can not work normally;
• Other conditions that the researcher considers inappropriate to participate in this study.

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead
• Xiangya Hospital of Central South University: collaborator
• National Natural Science Foundation of China: collaborator

Study Sites (2)

Xiangya Hospital, Central South University

Changsha, Hunan, 410000, China

RECRUITING

Yueyang Hospital, Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200030, China

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and induced sputum samples

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Lei-Miao Yin, MD

  Yueyang Hospital, Shanghai University of Traditional Chinese medicine

  STUDY CHAIR

• Jun-Tao Feng, MD

  Xiangya Hospital of Central South University

  STUDY DIRECTOR

Central Study Contacts

Lei-Miao Yin, MD

CONTACT

13774384237; collegeylm@shutcm.edu.cn

Jun-Tao Feng, MD

CONTACT

13786145799; jtfeng1976@csu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 11, 2022
• Study Start: November 1, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 8, 2024

Record last verified: 2024-04

Locations

CN (2)