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

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ClinicalTrials.gov Identifier: NCT04514913
Recruitment Status : Not yet recruiting
First Posted : August 17, 2020
Last Update Posted : March 11, 2021
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment
Asthma Mucus; Plug, Tracheobronchial 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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Study of Focal Airway Disease in Asthma Using Image Guided Bronchoscopy
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Biospecimen Retention:   Samples With DNA
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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04514913


Contacts
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Contact: Ariana Baum 415-514-1539 ariana.baum@ucsf.edu
Contact: Ndidi Njoku 415-476-1738 ndidi.njoku@ucsf.edu

Locations
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United States, California
UCSF Airway Clinical Research Center
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: John Fahy, MD, MSc University of California, San Francisco
Additional Information:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04514913    
Other Study ID Numbers: 19-27331
2P01HL107202-06A1 ( U.S. NIH Grant/Contract )
First Posted: August 17, 2020    Key Record Dates
Last Update Posted: March 11, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make IPD available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Asthma
Mucus Plug
Bronchoscopy
CT Scan
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases