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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma; Protein
• Intervention / Treatment: Other: No intervention.

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Lei-Miao Yin, MD; Phone Number: 86 21 54592134; Email: collegeylm@shutcm.edu.cn

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200030
      • Recruiting
      • Yueyang Hospital, Shanghai University of Traditional Chinese medicine
      • Contact: Lei-Miao Yin, MD; Phone Number: 86-21-54592134; Email: collegeylm@shutcm.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Referring to previous validation studies of target proteins in the literature, the sample size required for this validation experiment is related to multiple factors: (1) Selection of genes: mRNA differentially expressed genes will have a 50% probability of differential protein expression. (2) Antibody selection: Commercially available antibodies will be used for immunohistochemical detection of formalin-fixed, paraffin-embedded tissues with a success rate of up to 75%.

According to previous validation studies of the target protein, the required samples are 60 in each group, for a total of 120 samples.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Asthma group; No intervention.	Other: No intervention.; Observational study with no intervention.
Non-asthma group; No intervention.	Other: No intervention.; Observational study with no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunofluorescence results	IF	6 months
Immunohistochemistry results	IHC	6 months

Collaborators and Investigators

• Sponsor: Lei-Miao Yin
• Collaborators: Xiangya Hospital of Central South University; Shanghai Pulmonary Hospital, Shanghai, China; Shanghai 6th People's Hospital; Yueyang Hospital of Integrated Traditional Chinese and Western Medicine; Baoshan Hospital, Shanghai University of Traditional Chinese Medicine
• Investigators: Study Director: Jun-Tao Feng, MD, Xiangya Hospital of Central South University; Study Director: Lei-Miao Yin, MD, Yueyang Hospital, Shanghai University of Traditional Chinese medicine; Study Director: Wei-Wei He, MD, Shanghai 6th People's Hospital; Study Director: Li Li, MD, Baoshan Hospital, Shanghai University of Traditional Chinese Medicine; Study Director: Xiao-Ling Xu, MD, Shanghai pulmonary hospital, Tongji University

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 19, 2024
• First Submitted That Met QC Criteria: May 19, 2024
• First Posted (Actual): May 23, 2024

Study Record Updates

• Last Update Posted (Estimated): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Asthma; Airway smooth muscle; Ezrin; Pip5k1α
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: ShanghaiUTCM-0512

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: It is not yet known if there will be a plan to make IPD available.

Drug and device information, study documents

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