NCT02749565

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 25, 2016

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

September 12, 2019

Status Verified

November 1, 2018

Enrollment Period

7.3 years

First QC Date

April 7, 2016

Last Update Submit

September 11, 2019

Conditions

AsthmaOSA

Keywords

asthmafibrocyteairway remodelingOSAhypoxia

Outcome Measures

Primary Outcomes (1)

  • circulating fibrocyte proportion between asthmatic patient with OSA and without OSA

    baseline

Secondary Outcomes (1)

  • the change of circulating fibrocyte proportion in asthmatic patients with OSA

    baseline

Study Arms (2)

asthmatic patients with OSA

asthmatic patients without OSA

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • clinical diagnosis of asthma

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taipei, Taiwan

RECRUITING

Biospecimen

Retention: NONE RETAINED

circulating fibrocytes purified from PBMC

MeSH Terms

Conditions

AsthmaAirway RemodelingHypoxia

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • TSAI-YU WANG, MD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

TSAI-YU WANG, MD

CONTACT

wang5531@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2016

First Posted

April 25, 2016

Study Start

January 1, 2015

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

September 12, 2019

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)