Study of Focal Airway Disease in Asthma Using Image Guided Bronchoscopy

Asthma Clinical Trial

— SOFA  

Official title:

Study of Focal Airway Disease in Asthma Using Image Guided Bronchoscopy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04514913
• Other study ID #: 19-27331
• Secondary ID: 2P01HL107202-06A
• Status: Withdrawn
• Start date: February 2023
• Est. completion date: February 2023

Study information

• Verified date: February 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Mucus; Plug, Tracheobronchial

Intervention

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.

Locations

Country	Name	City	State
United States	UCSF Airway Clinical Research Center	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

•   Airway Clinical Research Center website