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

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ClinicalTrials.gov Identifier: NCT02749565
Recruitment Status : Recruiting
First Posted : April 25, 2016
Last Update Posted : January 25, 2018
Sponsor:
Collaborator:
Ministry of Science and Technology, Taiwan
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief Summary:
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

Condition or disease Intervention/treatment
Asthma OSA Device: continuous positive airway pressure (CPAP)

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
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: he Role of Endothelium A and EGFR Receptor in Fibrocytes From Asthma With Obstructive Sleep Apnea
Study Start Date : January 2015
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Sleep Apnea

Group/Cohort Intervention/treatment
asthmatic patients with OSA
CPAP titration will be applied patients decided CPAP treatment by themselves
Device: continuous positive airway pressure (CPAP)
The choice of CPAP treatment in asthmatic patients with OSA is depend on the decision of clinician and patient himself/herself.

asthmatic patients without OSA
No CPAP treatment



Primary Outcome Measures :
  1. circulating fibrocyte proportion between asthmatic patient with OSA and without OSA [ Time Frame: baseline ]

Secondary Outcome Measures :
  1. the change of circulating fibrocyte proportion in asthmatic patients with OSA [ Time Frame: baseline, 3 months under continuous positive airway pressure treatment ]

Biospecimen Retention:   Samples With DNA
circulating fibrocytes purified from PBMC


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • clinical diagnosis of asthma

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02749565


Contacts
Contact: TSAI-YU WANG, MD wang5531@gmail.com

Locations
Taiwan
Chang Gung Memorial Hospital Recruiting
Taipei, Taiwan
Contact: TSAI-YU WANG, MD       wang5531@gmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Ministry of Science and Technology, Taiwan
Investigators
Principal Investigator: TSAI-YU WANG, MD Chang Gung Memorial Hospital

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02749565     History of Changes
Other Study ID Numbers: 102-5744A3
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Chang Gung Memorial Hospital:
asthma
fibrocyte
airway remodeling
OSA
hypoxia

Additional relevant MeSH terms:
Asthma
Sleep Apnea, Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases