AsthmaSOFANCT04514913
Study of Focal Airway Disease in Asthma Using Image Guided Bronchoscopy
An observational study of Asthma and Mucus; Plug, Tracheobronchial, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Mucus; Plug, Tracheobronchial
- What is being tested?
- Multidetector Computed Tomography (MDCT) Scan and Virtual Navigation Bronchoscopy (VNB)
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2023to 9 Feb 2023
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants with asthma who present with or without mucus plugs, as well as healthy controls, all between the ages of 18 and 70.
Who may be able to join
- 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.
- 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.
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- 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.
- Asthma requiring treatment with inhaled corticosteroids (ICS) for 3 months or greater.
- Male or female between the ages of 18 and 70 years at Visit 1.
- 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.
- Asthma requiring treatment with inhaled corticosteroids (ICS) for 3 months or greater.
- A MDCT lung scan indicating a mucus plug accessible by bronchoscopy in at least one airway.
Who cannot join
- 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)
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- History of unstable cardiovascular disease.
- BMI > 45
- Currently taking anticoagulants.
- Group 2: Asthmatic Subjects without Mucus Plugs
- Asthma exacerbation or URI within the previous 6 weeks.
- Currently pregnant.
- Smoking of tobacco or other recreational inhalants in last month and/or >10 pack-year smoking history.
- Other chronic pulmonary disorders, including cystic fibrosis and chronic obstructive pulmonary disease.
- History of unstable cardiovascular disease.
- BMI > 45.
- Currently taking anticoagulants.
- Group 3: Asthmatic Subjects with Mucus Plugs
- Asthma exacerbation or URI within the previous 6 weeks.
- Currently pregnant.
- Smoking of tobacco or other recreational inhalants in last month and/or >10 pack-year smoking history.
- Other chronic pulmonary disorders, including cystic fibrosis and chronic obstructive pulmonary disease.
- History of unstable cardiovascular disease.
- BMI > 45.
- Currently taking anticoagulants.
- Mucus plugs inaccessible by bronchoscope.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Airway Clinical Research Center
San Francisco, California, 94143
About this study
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.
Read the detailed description
This is a single center study of 60 subjects. The investigators will enroll 30 subjects with asthma who demonstrate mucus plugging on a screening CT lung scan, 15 subjects with asthma without mucus plugging, and 15 healthy controls. The healthy controls and subjects with asthma but without mucus plugging with also undergo CT scans to confirm that their lungs aren't obstructed by mucus.
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. Subjects will participate in up to 5 study visits at the Airway Clinical Research Center.
- Conditions
- Asthma, Mucus; Plug, Tracheobronchial
- Being tested
- Multidetector Computed Tomography (MDCT) Scan, Virtual Navigation Bronchoscopy (VNB)
- Keywords
- Asthma, Mucus Plug, Bronchoscopy, CT Scan
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidetector Computed Tomography (MDCT) ScanRadiation
This is a low-dose CT scan of the chest using no contract material.
Virtual Navigation Bronchoscopy (VNB)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Participants with no history of asthma or other lung diseases. Receives: Radiation: Multidetector Computed Tomography (MDCT) Scan; Procedure: Virtual Navigation Bronchoscopy (VNB) | |
| Asthmatics without mucus plugs | Participants with asthma and no evidence of mucus plugging. Receives: Radiation: Multidetector Computed Tomography (MDCT) Scan; Procedure: Virtual Navigation Bronchoscopy (VNB) | |
| Asthmatics with mucus plugs | Participants with asthma and evidence by MDCT lung scan showing mucus plugging. Receives: Radiation: Multidetector Computed Tomography (MDCT) Scan; Procedure: Virtual Navigation Bronchoscopy (VNB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study startFeb 2023 (estimated)
- Primary completion9 Feb 2023
- Study completion9 Feb 2023
Why it 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.
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 University of California, San FranciscoThe 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
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- John Fahy, MD, MSc, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04514913
- Sponsor's protocol ID
- 19-27331
- Other IDs
- 2P01HL107202-06A1
- Acronym
- SOFA
- Status last verified
- Mar 2026
- First submitted
- 12 Aug 2020
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Focal Airway Disease in Asthma Using Image Guided Bronchoscopy
- ClinicalTrials.gov ID
- NCT04514913
- Acronym / sponsor ID
- SOFA / 19-27331
- Conditions
- Asthma, Mucus; Plug, Tracheobronchial
- Keywords
- Asthma, Mucus Plug, Bronchoscopy, CT Scan
- Study type
- Observational
- Recruitment status
- WithdrawnReason 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 2023 (estimated)
- Primary completion
- 9 Feb 2023 (actual)
- Study completion
- 9 Feb 2023 (actual)
- First posted
- 17 Aug 2020 (actual)
- 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.
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.
Detailed description
This is a single center study of 60 subjects. The investigators will enroll 30 subjects with asthma who demonstrate mucus plugging on a screening CT lung scan, 15 subjects with asthma without mucus plugging, and 15 healthy controls. The healthy controls and subjects with asthma but without mucus plugging with also undergo CT scans to confirm that their lungs aren't obstructed by mucus.
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. Subjects will participate in up to 5 study visits at the Airway Clinical Research Center.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | Radiation: Multidetector Computed Tomography (MDCT) Scan, Procedure: Virtual Navigation Bronchoscopy (VNB)Participants with no history of asthma or other lung diseases. |
| Asthmatics without mucus plugs | – | Radiation: Multidetector Computed Tomography (MDCT) Scan, Procedure: Virtual Navigation Bronchoscopy (VNB)Participants with asthma and no evidence of mucus plugging. |
| Asthmatics with mucus plugs | – | Radiation: Multidetector Computed Tomography (MDCT) Scan, Procedure: Virtual Navigation Bronchoscopy (VNB)Participants with asthma and evidence by MDCT lung scan showing mucus plugging. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with asthma who present with or without mucus plugs, as well as healthy controls, all between the ages of 18 and 70.
Key inclusion criteria (16 listed)
- 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.
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidetector Computed Tomography (MDCT) ScanThis is a low-dose CT scan of the chest using no contract material. | Radiation | Asthmatics with mucus plugs, Asthmatics without mucus plugs, Healthy Controls |
| Virtual Navigation Bronchoscopy (VNB)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. | Procedure or surgery | Asthmatics with mucus plugs, Asthmatics without mucus plugs, Healthy Controls |
Primary outcome
Difference in eosinophil percentage in broncheoalveolar biospecimens between asthmatic and non-asthmatic airways
Time frame: 6 months
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.
Difference in gene expression of genes that mark IL-13 activation between asthmatic and non-asthmatic airways
Time frame: 6 months
Genes such as periostin, CLCA1, and Serpin B2 will be analyzed for expression in epithelial cell brushings.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Airway Clinical Research Center websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to make IPD available to other researchers.
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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.
John Fahy, MD, MSc principal investigator
University of California, San Francisco
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 Mucus; Plug, Tracheobronchial, run by University of California, San Francisco at 1 site in United States.
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 16 inclusion and 26 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: withdrawn, as of the sponsor's last update on 6 Mar 2026. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in eosinophil percentage in broncheoalveolar biospecimens between asthmatic and non-asthmatic airways (time frame: 6 months). The study lists 2 primary outcomes in all. 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 6 Mar 2026.