NCT06105710 · University of California, San Francisco
Mechanistic Insights From Bronchoscopy Airway Samples
(MIBAS)
What this study is about
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.
View original scientific description
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.
Primary outcome measures
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.
Time frame: Between 1-12 weeks
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
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.
Time frame: Between 1-12 weeks
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.
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.
Time frame: Between 1-12 weeks
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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)
Exclusion criteria
- The same exclusion criteria will apply to both Sub-studies.
- 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
- 10 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
- Salmeterol: 2 days
- Omalizumab: 6 months Medications to be withheld prior to bronchoscopy: Aspirin or Non- steroidal anti-inflammatory agents (NSAIDs) for 2 days Medications to be withheld before each clinic visit: Short-acting bronchodilators (e.g. Albuterol) for 6 hours; Short-acting anti- cholinergics (e.g. Atrovent, Combivent) for 8 hours; and antihistamines (e.g. Benadryl, Claritin) for 3 days.
Where
- San Francisco, California
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 24, 2026 · Source of record for eligibility and locations