Mechanistic Insights From Bronchoscopy Airway Samples

NCT06105710 | Recruiting

• 2 other identifiers: 23-399442U19AI077439-16
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the mechanisms of asthma. The investigators are comparing the cells of individuals with and without asthma and looking at the roles various parts of the cell play in the production and secretion of mucus.

Conditions

Asthma

Keywords

Asthma

Outcome Measures

Primary Outcomes (3)

• Quantitate mean gene expression of TSPAN8 in goblet cells from the airways of human asthma and health and report the mean for asthma and health (main outcome 1) and for both goblet cells and non-goblet cells in asthma.

  Specifically, gene expression will be interrogated in single cells via 10x droplet-based RNA sequencing of airway brushings obtained from bronchoscopy. The gene expression data is used to characterize individuals cells as goblet cells vs other cells. TSPAN8 is then quantitated via the data in these cells

  Between 1-12 weeks

• Quantitate KRT8 in airway cells from human asthma vs health and report the mean level in the transitional secretory cell subset for both asthma and health.

  Using 10x droplet-based single-cell RNA sequencing, the investigators will interrogate expression in cells that are classified as a transitional secretory cell subset. The investigators will classify transcriptionally similar cells from airway brushings into discrete clusters using the single-cell RNA sequencing data from airway brushings obtained from bronchoscopy (Seurat4 package). The investigators will then map clusters to cell types and transitional states based on published human and mouse scRNAseq data from airway cells. Differentiation trajectories will be inferred using diffusion modeling (Monocle3 package) and analyze nascent versus mature mRNA expression (scVelo package). Investigators will then map KRT8 expression onto these cells and clusters.

  Between 1-12 weeks

• Quantitate expression of miR-141/200 family members report mean expression for the transitional secretory cell population in human asthma vs health using methods similar to those in Outcomes 1 and 2.

  Between 1-12 weeks

Study Arms (2)

Asthma

Participants with a history of asthma

Healthy Controls

Participants without a history of asthma

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy and asthmatic participants recruited from community advertising

You may qualify if:

• Healthy Controls
• Male and female subjects between the ages of 18 and 70 years
• Ability to provide written informed consent and ability to comply with the requirements of the study
• No hyperreactivity to methacholine (PC20 FEV1 Methacholine \>16 mg/mL)
• No history of allergic rhinitis/seasonal allergies
• Asthmatics
• Male and female subjects between the ages of 18 and 70 years
• Ability to provide written informed consent and ability to comply with the requirements of the study
• History of asthma
• No use of oral or inhaled corticosteroids for the treatment of asthma during the past 6 weeks
• Hyperreactivity to methacholine (PC20 FEV1 Methacholine \< 8 mg/ml)

You may not qualify if:

• Current smokers, defined by (a) \>5 cigarettes smoked in past 12 months, and (b) ≤ 8 weeks since last time smoking; or former smokers who have a total smoking history
• pack-years
• Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
• Subjects with a history of lung disease other than asthma
• Subjects with a history of prior esophageal hernia surgery
• Subjects with a history of a medical disease, which in the opinion of the Investigator may put the subject at extra risk from study-related procedures or because the disease may influence the results of the study
• Current participation in an investigational drug trial
• Prohibited Medications and Treatments The following medications are prohibited during the study and must be discontinued prior to enrollment for the amount of time specified below.
• Astemizole: 12 weeks
• Steroids (oral, inhaled or nasal): 6 weeks
• Nedocromil sodium, sodium cromoglycate: 4 weeks
• Long-acting methylxantines: 2 days
• Short-acting methylxantines: 12 hours
• Montelukast: 7 days
• Zafirlukast: 7 days

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Bronchial brushes, lavage, and biopsies. Sputum, induced. Whole blood, serum, plasma

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Nirav Bhakta, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Prescott Woodruff, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine P Nguyen, BS

CONTACT

628-233-1233; christine.nguyen@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 30, 2023
• Study Start: July 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)