Recruiting
Mechanistic Insights From Bronchoscopy Airway Samples
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.
ClinicalTrials.gov IDNCT06105710
PhaseNot Applicable
Enrollment24
SponsorUniversity of California, San Francisco
Age18 Years
SexALL
Conditions studied
Asthma
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.
Primary outcomes
- 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. (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. (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)
Eligibility information
Inclusion Criteria:
* Healthy Controls
1. Male and female subjects between the ages of 18 and 70 years
2. Ability to provide written informed consent and ability to comply with the requirements of the study
3. No hyperreactivity to methacholine (PC20 FEV1 Methacholine \>16 mg/mL)
4. No history of allergic rhinitis/seasonal allergies
* Asthmatics
1. Male and female subjects between the ages of 18 and 70 years
2. Ability to provide written informed consent and ability to comply with the requirements of the study
3. History of asthma
4. No use of oral or inhaled corticosteroids for the treatment of asthma during the past 6 weeks
5. Hyperreactivity to methacholine (PC20 FEV1 Methacholine \< 8 mg/ml)
Exclusion Criteria:
The same exclusion criteria will apply to both Sub-studies.
1. 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
2. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
3. Subjects with a history of lung disease other than asthma
4. Subjects with a history of prior esophageal hernia surgery
5. 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
6. 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.
1. Astemizole: 12 weeks
2. Steroids (oral, inhaled or nasal): 6 weeks
3. Nedocromil sodium, sodium cromoglycate: 4 weeks
4. Long-acting methylxantines: 2 days
5. Short-acting methylxantines: 12 hours
6. Montelukast: 7 days
7. Zafirlukast: 7 days
8. Salmeterol: 2 days
9. 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.
Study locations
- University of California, San Francisco, San Francisco, California 94143 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.