AsthmaNCT02749565
The Role of Endothelium A and EGFR Receptor in Fibrocytes From Asthma With Obstructive Sleep Apnea
An observational study of Asthma and OSA, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2015to Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- clinical diagnosis of asthma
Who cannot join
- chronic obstructive pulmonary disease (COPD)
- bronchiectasis
- cystic fibrosis
Trial locations and contacts
1 site in 1 country.
TSAI-YU WANG, MD contact
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taipei
TSAI-YU WANG, MD, wang5531@gmail.com
About this study
Official title: 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
Read the 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.
- Keywords
- asthma, fibrocyte, airway remodeling, OSA, hypoxia
- Medical subject headings
- Asthma, Airway Remodeling, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| asthmatic patients with OSA | Not described | |
| asthmatic patients without OSA | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
circulating fibrocyte proportion between asthmatic patient with OSA and without OSA
Measured: baseline
Secondary outcomes (1)
the change of circulating fibrocyte proportion in asthmatic patients with OSA
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startJan 2015
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (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.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Sponsor
- Investigators
- TSAI-YU WANG, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749565
- Sponsor's protocol ID
- 102-5744A3
- Status last verified
- Nov 2018
- First submitted
- 7 Apr 2016
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- he Role of Endothelium A and EGFR Receptor in Fibrocytes From Asthma With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT02749565
- Acronym / sponsor ID
- 102-5744A3
- Keywords
- asthma, fibrocyte, airway remodeling, OSA, hypoxia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- Jan 2015
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 25 Apr 2016 (estimated)
- 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.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| asthmatic patients with OSA | – | – |
| asthmatic patients without OSA | – | – |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- clinical diagnosis of asthma
Key exclusion criteria (3 listed)
- chronic obstructive pulmonary disease (COPD)
- bronchiectasis
- cystic fibrosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
circulating fibrocyte proportion between asthmatic patient with OSA and without OSA
Time frame: baseline
1 secondary outcome
the change of circulating fibrocyte proportion in asthmatic patients with OSA
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
TSAI-YU WANG, MD contact
TSAI-YU WANG, MD principal investigator
Chang Gung Memorial Hospital
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 OSA, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 12 Sep 2019. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact TSAI-YU WANG, MD (wang5531@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
circulating fibrocyte proportion between asthmatic patient with OSA and without OSA (time frame: baseline). 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 12 Sep 2019.