## Protocol Section
### Identification Module
**NCT ID:** NCT06427018

**Brief Title:** Expressions of Ezrin and Pip5k1α Proteins in Airway Smooth Muscle of Asthmatic Patients

**Official Title:** Assessing the Expressions of Ezrin, Phosphorylated Ezrin, and Pip5k1α in the Airway Smooth Muscle of Asthmatic Patient

#### Organization Study ID Info
**ID:** ShanghaiUTCM-0512
#### Organization
**Class:** OTHER
**Full Name:** Shanghai University of Traditional Chinese Medicine
### Status Module
#### Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-28

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Yueyang Hospital of Integrated Traditional Chinese and Western Medicine

**Class:** OTHER

**Name:** Shanghai 6th People's Hospital

**Class:** OTHER

**Name:** Xiangya Hospital of Central South University

**Class:** UNKNOWN

**Name:** Baoshan Hospital, Shanghai University of Traditional Chinese Medicine

#### Lead Sponsor

**Class:** OTHER

**Name:** Lei-Miao Yin

#### Responsible Party

**Investigator Affiliation:** Shanghai University of Traditional Chinese Medicine

**Investigator Full Name:** Lei-Miao Yin

**Investigator Title:** Prof.

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief 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.

**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.

### Conditions Module

**Conditions:**

- Asthma

- Protein

**Keywords:**

- Asthma

- Ezrin

- Pip5k1α

- Airway smooth muscle

### Design Module

#### Bio Spec

**Description:** Tissue

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** No intervention.

**Intervention Names:**

- Other: No intervention.

**Label:** Asthma group

#### Arm Group 2

**Description:** No intervention.

**Intervention Names:**

- Other: No intervention.

**Label:** Non-asthma group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Asthma group

- Non-asthma group

**Description:** Observational study with no intervention.

**Name:** No intervention.

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** IF

**Measure:** Immunofluorescence results

**Time Frame:** 6 months

**Description:** IHC

**Measure:** Immunohistochemistry results

**Time Frame:** 6 months

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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 30 in each group, for a total of 60 samples.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** collegeylm@shutcm.edu.cn

**Name:** Lei-Miao Yin, MD

**Phone:** 86 21 54592134

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Shanghai

**Contacts:**

***Contact 1:***

- **Email:** collegeylm@shutcm.edu.cn

- **Name:** Lei-Miao Yin, MD

- **Phone:** 86-21-54592134

- **Role:** CONTACT

**Country:** China

**Facility:** Yueyang Hospital, Shanghai University of Traditional Chinese Medicine

**State:** Shanghai

**Status:** RECRUITING

**Zip:** 200030

#### Overall Officials

**Official 1:**

**Affiliation:** Yueyang Hospital, Shanghai University of Traditional Chinese medicine

**Name:** Lei-Miao Yin, MD

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** Shanghai 6th People's Hospital

**Name:** Wei-Wei He, MD

**Role:** STUDY_DIRECTOR

**Official 3:**

**Affiliation:** Xiangya Hospital of Central South University

**Name:** Jun-Tao Feng, MD

**Role:** STUDY_DIRECTOR

**Official 4:**

**Affiliation:** Baoshan Hospital, Shanghai University of Traditional Chinese Medicine

**Name:** Li Li, MD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Description:** It is not yet known if there will be a plan to make IPD available.

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001982

- Term: Bronchial Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000008173

- Term: Lung Diseases, Obstructive

- ID: D000008171

- Term: Lung Diseases

- ID: D000012130

- Term: Respiratory Hypersensitivity

- ID: D000006969

- Term: Hypersensitivity, Immediate

- ID: D000006967

- Term: Hypersensitivity

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4556

- Name: Asthma

- Relevance: HIGH

- As Found: Asthma

- ID: M5258

- Name: Bronchial Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11170

- Name: Lung Diseases, Obstructive

- Relevance: LOW

- As Found: Unknown

- ID: M10018

- Name: Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M14967

- Name: Respiratory Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M10020

- Name: Hypersensitivity, Immediate

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001249

- Term: Asthma

### Misc Info Module

- Version Holder: 2024-05-31
