Status:
WITHDRAWN
Study of Focal Airway Disease in Asthma Using Image Guided Bronchoscopy
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Asthma
Mucus; Plug, Tracheobronchial
Eligibility:
All Genders
18-70 years
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 dete...
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 pl...
Eligibility Criteria
Inclusion
- Group 1: Healthy Controls
- 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
- 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.
Key Trial Info
Start Date :
February 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04514913
Start Date
February 1 2023
End Date
February 1 2023
Last Update
July 31 2025
Active Locations (1)
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1
UCSF Airway Clinical Research Center
San Francisco, California, United States, 94143