AsthmaNCT06427018
Expressions of Ezrin and Pip5k1α Proteins in Airway Smooth Muscle of Asthmatic Patients
An observational study of Asthma and Protein, run by Lei-Miao Yin at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 28 May 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- 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 60 in each group, for a total of 120 samples.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Yueyang Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200030
Lei-Miao Yin, MD, 86-21-54592134, collegeylm@shutcm.edu.cn
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- No intervention.
- Keywords
- Asthma, Ezrin, Pip5k1α, Airway smooth muscle
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention.Other
Observational study with no intervention.
| Study group | Role | What they receive |
|---|---|---|
| Asthma group | No intervention. Receives: Other: No intervention. | |
| Non-asthma group | No intervention. Receives: Other: No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunofluorescence results
IF
Measured: 6 months
Immunohistochemistry results
IHC
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start28 May 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei-Miao Yin
- Sponsor type
- University, hospital or other
- Collaborators
- Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai 6th People's Hospital, Xiangya Hospital of Central South University, Baoshan Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai Pulmonary Hospital, Shanghai, China
- Responsible party
- Sponsor-investigator, Lei-Miao Yin, Shanghai University of Traditional Chinese Medicine
- Investigators
- Lei-Miao Yin, MD, Study director, Yueyang Hospital, Shanghai University of Traditional Chinese medicineWei-Wei He, MD, Study director, Shanghai 6th People's HospitalJun-Tao Feng, MD, Study director, Xiangya Hospital of Central South UniversityLi Li, MD, Study director, Baoshan Hospital, Shanghai University of Traditional Chinese MedicineXiao-Ling Xu, MD, Study director, Shanghai Pulmonary Hospital, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427018
- Sponsor's protocol ID
- ShanghaiUTCM-0512
- Status last verified
- Jan 2026
- First submitted
- 19 May 2024
- Last updated
- 14 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Expressions of Ezrin, Phosphorylated Ezrin, and Pip5k1α in the Airway Smooth Muscle of Asthmatic Patient
- ClinicalTrials.gov ID
- NCT06427018
- Acronym / sponsor ID
- ShanghaiUTCM-0512
- Keywords
- Asthma, Ezrin, Pip5k1α, Airway smooth muscle
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Lei-Miao YinUniversity, hospital or other
- Collaborators
- Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai 6th People's Hospital, Xiangya Hospital of Central South University, Baoshan Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai Pulmonary Hospital, Shanghai, China
- Study start
- 28 May 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma group | – | Other: No intervention.No intervention. |
| Non-asthma group | – | Other: No intervention.No intervention. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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 60 in each group, for a total of 120 samples.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention.Observational study with no intervention. | Other | Asthma group, Non-asthma group |
Primary outcome
Immunofluorescence results
Time frame: 6 months
IF
Immunohistochemistry results
Time frame: 6 months
IHC
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lei-Miao Yin, MD study director
Yueyang Hospital, Shanghai University of Traditional Chinese medicine
Wei-Wei He, MD study director
Shanghai 6th People's Hospital
Jun-Tao Feng, MD study director
Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Protein, run by Lei-Miao Yin at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lei-Miao Yin, MD (86 21 54592134, collegeylm@shutcm.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunofluorescence results (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.