The Role of Endothelium A and EGFR Receptor in Fibrocytes From Asthma With Obstructive Sleep Apnea

September 11, 2019 updated by: Chang Gung Memorial Hospital

he Role of Endothelium A and EGFR Receptor in Fibrocytes From Asthma With Obstructive Sleep Apnea

The investigators will compare the circulating fibrocyte proportion in asthmatic patients with obstructive sleep apnea (OSA) and not with OSA In addition, the investigators will compare the expression of epidermal growth factor receptor (EGFR), endothelin A receptor (ETAR) and connective tissue growth factor (CTGF) The association of those factors and annual decline of forced expiratory volume in 1 second (FEV1) will be performed

Study Overview

Status

Unknown

Conditions

Detailed Description

Asthma is characterized by airflow obstruction, chronic airway inflammation and remodeling. The investigators' report has shown directly the relationship between fibrocytes, and chronic airflow obstruction with rapid decline in FEV1 in asthma. Asthma concomitant of obstructive sleep apnea (OSA) may appear intermittent hypoxia and result in the frequent attack of asthma symptoms. In animal model, hypoxia may increase the circulating fibrocytes, thus play a role in pulmonary hypertension. The investigators' published paper also showed that an increased expression of EGFR, ETAR and Vascular endothelial growth factor receptor (VEGFR) in circulating fibrocytes in chronic obstructive asthmatics. It is unknown whether circulating fibrocytes from asthma with OSA have the higher expression of EGFR, connective tissue growth factor receptor, VEGFR and ETAR compared to asthma without OSA. The investigators are also interested in whether proliferation and differentiation of fibrocytes are different between asthmatics with or without concomitant of OSA. The investigators will study the correlation between the percentage of circulating fibrocytes and the oxygen desaturation index (ODI) and severity of sleep apnea to clarify the role of hypoxia, which contributing to chronic asthma.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

the diagnosis of asthma based on current or past smoking history, clinical evaluation, and pulmonary function testing showing airflow obstruction (FEV1/FVC < 70%) with a change in FEV1 of large than 200 ml and 12% in the bronchodilator test will be enrolled.

Description

Inclusion Criteria:

  • clinical diagnosis of asthma

Exclusion Criteria:

  • chronic obstructive pulmonary disease (COPD)
  • bronchiectasis
  • cystic fibrosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
asthmatic patients with OSA
asthmatic patients without OSA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
circulating fibrocyte proportion between asthmatic patient with OSA and without OSA
Time Frame: baseline
baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
the change of circulating fibrocyte proportion in asthmatic patients with OSA
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Collaborators

Ministry of Science and Technology, Taiwan

Investigators

  • Principal Investigator: TSAI-YU WANG, MD, Chang Gung memorial hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

April 7, 2016

First Submitted That Met QC Criteria

April 22, 2016

First Posted (Estimate)

April 25, 2016

Study Record Updates

Last Update Posted (Actual)

September 12, 2019

Last Update Submitted That Met QC Criteria

September 11, 2019

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 102-5744A3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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