Study of Focal Airway Disease in Asthma Using Image Guided Bronchoscopy (SOFA)

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.

Study Overview

• Status: Withdrawn
• Conditions: Asthma; Mucus; Plug, Tracheobronchial
• Intervention / Treatment: Radiation: Multidetector Computed Tomography (MDCT) Scan; Procedure: Virtual Navigation Bronchoscopy (VNB)

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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • UCSF Airway Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

Group 1: Healthy Controls

Inclusion 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.

Exclusion Criteria:

• 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

Inclusion 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.
• 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.

Exclusion Criteria:

• 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

Inclusion:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Controls; Participants with no history of asthma or other lung diseases.	Radiation: Multidetector Computed Tomography (MDCT) Scan; This is a low-dose CT scan of the chest using no contract material.; Procedure: 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.
Asthmatics without mucus plugs; Participants with asthma and no evidence of mucus plugging.	Radiation: Multidetector Computed Tomography (MDCT) Scan; This is a low-dose CT scan of the chest using no contract material.; Procedure: 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.
Asthmatics with mucus plugs; Participants with asthma and evidence by MDCT lung scan showing mucus plugging.	Radiation: Multidetector Computed Tomography (MDCT) Scan; This is a low-dose CT scan of the chest using no contract material.; Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: John Fahy, MD, MSc, University of California, San Francisco

Publications and helpful links

Helpful Links

• Airway Clinical Research Center website

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2023
• Primary Completion (Actual): February 9, 2023
• Study Completion (Actual): February 9, 2023

Study Registration Dates

• First Submitted: August 12, 2020
• First Submitted That Met QC Criteria: August 12, 2020
• First Posted (Actual): August 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Asthma; Bronchoscopy; CT Scan; Mucus Plug
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: 19-27331; 2P01HL107202-06A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make IPD available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No