Expressions of Ezrin and Pip5k1α Proteins in Airway Smooth Muscle of Asthmatic Patients

Asthma Clinical Trial

Official title:

Assessing the Expressions of Ezrin, Phosphorylated Ezrin, and Pip5k1α in the Airway Smooth Muscle of Asthmatic Patient

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06427018
• Other study ID #: ShanghaiUTCM-0512
• Status: Recruiting
• Start date: May 28, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: Lei-Miao Yin, MD
• Phone: 86 21 54592134
• Email: collegeylm[@]shutcm.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Asthma, a prevalent chronic respiratory affliction, significantly impinges upon the quality of life for affected individuals. Timely and appropriate diagnostic measures, coupled with efficacious therapeutic interventions, are paramount in mitigating exacerbations of symptoms and enhancing the life quality of patients.

Ezrin plays an important role in maintaining cell morphology, cell migration, cell adhesion and polarisation, but Ezrin expression in airway smooth muscle remains unclear.

Pip5k1α is an important kinase involved in intracellular phosphatidylinositol signalling pathways that may be involved in smooth muscle contraction and diastole.

Therefore, further studies are necessary to elucidate the changes of Ezrin and Pip5k1α in patients with asthma to provide a basis for investigating alternative treatments for asthma.

Description:

Asthma is a complex and heterogeneous disease with a combination of genetic and environmental multifactors, which is mainly characterised by recurrent episodes of wheezing, shortness of breath, chest tightness and cough. The nature of the pathology manifests itself as a chronic inflammatory disease with abnormal antigen presentation and T-cell activation, and an imbalance of Th1/Th2 cells leading to dysfunction of airway smooth muscle cells. There is a lack of safe and effective medications against asthma for current treatment. For example, although glucocorticosteroids are the first-line drugs for asthma, only 12% of patients are able to use them in accordance with medical advice. β2 agonists are often used in combination with hormones, but up to 55% of asthmatics still fail to get effective control of their symptoms. Therefore, the development of innovative drugs with new targets and mechanisms has become the trend of asthma drug development at home and abroad. The discovery of new asthma targets will help to elucidate the asthma mechanism and solve a series of problems in clinical treatment.

Ezrin is one of the major members of the Ezrin-Radixin-Moesin (ERM) family, which plays an important role in the maintenance of cell morphology, cell migration, cell adhesion and polarisation. Pip5k1α is an important kinase involved in the intracellular phosphatidylinositol signaling pathway, which may be associated with the smooth muscle contraction and diastole related.

In a previous study, single-cell sequencing of lung tissue from asthmatic mice revealed that Ezrin and Pip5k1α were significantly increased in asthmatic airway smooth muscle cells. In vitro cellular experiments suggested that Ezrin and Pip5k1α inhibition could inhibit airway smooth muscle cell contraction, suggesting that inhibitors of both may provide a therapeutic advantage for reducing lung resistance in asthma. Therefore, further studies to elucidate the changes of Ezrin and Pip5k1α in asthma patients are warranted to provide a basis for the use of inhibitors of both as an alternative treatment for asthma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Lung tissue samples;

• The samples come from patients aged 18-70 years old, regardless of gender, who underwent lung tissue sampling for surgical indications during treatment;

• Paraffin sections of lung tissue from patients diagnosed with bronchial asthma, including tracheal smooth muscle;

• Paraffin sections of lung tissue from non-asthma patients, including tracheal smooth muscle.

Exclusion Criteria:

• Paraffin sections of lung tissue from patients who have been diagnosed with COPD;

• Other situations where the researcher deems it inappropriate to participate in this study.

Related Conditions & MeSH terms

• Asthma
• Protein

Intervention

Other:
• No intervention.
Observational study with no intervention.

Locations

Country	Name	City	State
China	Yueyang Hospital, Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai

Sponsors (5)

Lead Sponsor	Collaborator
Lei-Miao Yin	Baoshan Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 6th People's Hospital, Xiangya Hospital of Central South University, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunofluorescence results	IF	6 months
Primary	Immunohistochemistry results	IHC	6 months