Clinical trial NCT05496582: The Association of Transgelin-2, Metallothionein-2 and Ezrin With Asthma
Official title: The Association of Transgelin-2, Metallothionein-2 and Ezrin With Asthma: A Case-control Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Asthma
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Xiangya Hospital of Central South University
name: National Natural Science Foundation of China
First posted: 2022-08-11
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with asthma or non-asthma

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.

Detailed description: This study will investigate the changes and associations in asthma. In this project, the investigators will explore the changes of gene expression of transgelin-2, metallothionein-2 and ezrin in asthma and investigate their correlation with current diagnosis markers of asthma, including pulmonary function, fractional exhaled nitric oxide,eosinophil counts,immunoglobulin E, interleukin-5, etc.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Patients with chronic obstructive pulmonary disease or other airway disease;
2. 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;
3. Women who are known to be pregnant or breastfeeding;
4. Not willing to participate;
5. Psychiatric history and neurological disorders can not work normally;
6. Other conditions that the researcher considers inappropriate to participate in this study.

Primary outcomes:
measure: Difference in gene expression of transgelin-2, metallothionein-2 and ezrin between controls and asthmatic patients
timeFrame: Two year
measure: Association of transgelin-2, metallothionein-2 and ezrin with asthma
timeFrame: Two year
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
state: Hunan
city: Shanghai
country: China
facility: Yueyang Hospital, Shanghai University of Traditional Chinese Medicine
state: Shanghai
Study officials:
affiliation: Yueyang Hospital, Shanghai University of Traditional Chinese medicine
name: Lei-Miao Yin, MD
role: STUDY_CHAIR
affiliation: Xiangya Hospital of Central South University
name: Jun-Tao Feng, MD
role: STUDY_DIRECTOR
References: