Study Stopped
The restrictions on research imposed for the COVID-19 pandemic prevented us from launching study recruitment and visits. At this stage our funding is not sufficient to allow us to enroll sufficient numbers of patients so we will close the study.
Study of Focal Airway Disease in Asthma Using Image Guided Bronchoscopy
SOFA
2 other identifiers
observational
N/A
1 country
1
Brief Summary
This is a single center study of 60 subjects including those with asthma and mucus plugging, those with asthma and without mucus plugging, and healthy controls. Screening data will be reviewed to determine participant eligibility. Participants who meet all inclusion criteria will participate in image-guided bronchoscopy ("virtual navigation bronchoscopy" \[VNB\]) to sample airway biospecimens in mucus plugged and control airways.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2020
CompletedFirst Posted
Study publicly available on registry
August 17, 2020
CompletedStudy Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 9, 2023
CompletedMarch 6, 2026
March 1, 2026
8 days
August 12, 2020
March 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Difference in eosinophil percentage in broncheoalveolar biospecimens between asthmatic and non-asthmatic airways
The investigators will examine differences in type-2 inflammatory markers in bronchoalveolar biospecimens. Eosinophils are an indicator of type 2 inflammation in bronchial lavage samples. Indicators of airway inflammation will be compared with healthy control biospecimens and those of non-mucus plugged asthmatics.
6 months
Difference in gene expression of genes that mark IL-13 activation between asthmatic and non-asthmatic airways
Genes such as periostin, CLCA1, and Serpin B2 will be analyzed for expression in epithelial cell brushings.
6 months
Study Arms (3)
Healthy Controls
Participants with no history of asthma or other lung diseases.
Asthmatics without mucus plugs
Participants with asthma and no evidence of mucus plugging.
Asthmatics with mucus plugs
Participants with asthma and evidence by MDCT lung scan showing mucus plugging.
Interventions
This is a low-dose CT scan of the chest using no contract material.
This is a procedure where a camera will be inserted into the lung in order to guide sample collection of bronchoalveolar lavages, bronchail brushes and endobronchial biopsies.
Eligibility Criteria
Participants with asthma who present with or without mucus plugs, as well as healthy controls, all between the ages of 18 and 70.
You may qualify if:
- Male or female between the ages of 18 and 70 years at Visit 1 and at least 50% whose age is \> 40 years (to ensure age balance among groups and anticipating that group 3 subjects will be older).
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
- Able to perform reproducible spirometry according to ATS criteria.
You may not qualify if:
- Upper respiratory tract infection (URI) within the previous 6 weeks.
- History of lung disease.
- Smoking of tobacco or other recreational inhalants in last month and/or \>10 pack-year smoking history.
- Currently pregnant.
- History of allergic rhinitis.
- Laboratory evidence of atopy (blood eosinophils \> 0.4 cells/dL, IgE \> 165 IU/mL)
- History of unstable cardiovascular disease.
- BMI \> 45
- Currently taking anticoagulants.
- Group 2: Asthmatic Subjects without Mucus Plugs
- Male or female between the ages of 18 and 70 years at Visit 1 and at least 50% whose age is \> 40 years (to ensure age balance among groups and anticipating that group 3 subjects will be older).
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
- Able to perform reproducible spirometry according to ATS criteria.
- Physiological evidence of airflow obstruction (FEV1 bronchodilator reversibility of ≥ 12% or hyperreactivity to methacholine reflected by a methacholine PC20 ≤ 16 mg/mL). Historical methacholine data from previous studies conducted in the past 5 years at the UCSF ACRC will be allowed.
- Clinical history of asthma per patient report or medical record.
- +24 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCSF Airway Clinical Research Center
San Francisco, California, 94143, United States
Related Links
Biospecimen
bronchoalveolar lavage from airways in 1-2 bronchopulmonary segments, bronchial brushes from airways in 2-3 bronchopulmonary segments, endobronchial biopsies from airways in 2-3 bronchopulmonary segments, and blood.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Fahy, MD, MSc
University of California, San Francisco
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2020
First Posted
August 17, 2020
Study Start
February 1, 2023
Primary Completion
February 9, 2023
Study Completion
February 9, 2023
Last Updated
March 6, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
There is no plan to make IPD available to other researchers.