AsthmaMIBASNCT06105710
Mechanistic Insights From Bronchoscopy Airway Samples
An observational study of Asthma, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to Dec 2028
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy and asthmatic participants recruited from community advertising
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Christine Nguyen, BS, 628-233-1233, christine.nguyen@ucsf.edu
About this study
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.
Read the detailed description
The UCSF Airway Clinical Research Center has made longstanding and productive efforts to understand how type 2 immune responses in the airway act on epithelial cells to produce muco-obstructive pathology, a central feature of severe asthma and a major contributor to fatality from this disease. This center has made major contributions to identifying type 2 high asthma as the major asthma endotype, demonstrating that the type 2 cytokine IL-13 acts directly on airway epithelial cells to induce pathological changes in mucus, and showing that mucus plugging is a persistent feature of asthma that is associated with type 2 responses and with increased asthma severity. The overall objective of this proposal is to understand molecular mechanisms that account for alterations in secretory cell and mucus function that are important in severe asthma. The overarching hypothesis is that local type 2 immune responses induce IL-13-mediated changes in epithelial gene expression and that these changes, which involve several novel molecular mechanisms not previously explored, alter differentiation of secretory cells and production and secretion of mucins, leading to mucus plugging and airway obstruction. The proposal includes two highly related projects, each of which focuses on molecules and pathways that have previously unknown roles in secretory cell biology and mucus dysfunction. The proposed studies will provide new mechanistic insights that are highly relevant to the pathogenesis of severe asthma and may lead to novel therapeutic targets that address unmet needs.
- Conditions
- Asthma
- Keywords
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asthma | Participants with a history of asthma | |
| Healthy Controls | Participants without a history of asthma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: Between 1-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 Jul 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nirav Bhakta, MD, PhD, Principal investigator, University of California, San FranciscoPrescott Woodruff, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105710
- Sponsor's protocol ID
- 23-39944
- Other IDs
- 2U19AI077439-16
- Acronym
- MIBAS
- Status last verified
- Apr 2026
- First submitted
- 23 Oct 2023
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanistic Insights From Bronchoscopy Airway Samples
- ClinicalTrials.gov ID
- NCT06105710
- Acronym / sponsor ID
- MIBAS / 23-39944
- Conditions
- Asthma
- Keywords
- Asthma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The UCSF Airway Clinical Research Center has made longstanding and productive efforts to understand how type 2 immune responses in the airway act on epithelial cells to produce muco-obstructive pathology, a central feature of severe asthma and a major contributor to fatality from this disease. This center has made major contributions to identifying type 2 high asthma as the major asthma endotype, demonstrating that the type 2 cytokine IL-13 acts directly on airway epithelial cells to induce pathological changes in mucus, and showing that mucus plugging is a persistent feature of asthma that is associated with type 2 responses and with increased asthma severity. The overall objective of this proposal is to understand molecular mechanisms that account for alterations in secretory cell and mucus function that are important in severe asthma. The overarching hypothesis is that local type 2 immune responses induce IL-13-mediated changes in epithelial gene expression and that these changes, which involve several novel molecular mechanisms not previously explored, alter differentiation of secretory cells and production and secretion of mucins, leading to mucus plugging and airway obstruction. The proposal includes two highly related projects, each of which focuses on molecules and pathways that have previously unknown roles in secretory cell biology and mucus dysfunction. The proposed studies will provide new mechanistic insights that are highly relevant to the pathogenesis of severe asthma and may lead to novel therapeutic targets that address unmet needs.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma | – | –Participants with a history of asthma |
| Healthy Controls | – | –Participants without a history of asthma |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy and asthmatic participants recruited from community advertising
Key inclusion criteria (11 listed)
- Healthy Controls
- Asthmatics
Key exclusion criteria (19 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nirav Bhakta, MD, PhD principal investigator
University of California, San Francisco
Prescott Woodruff, MD, MPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine P Nguyen, BS (628-233-1233, christine.nguyen@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026; AzTrials last refreshed its copy on 31 Oct 2026.