RecruitingNot Applicable

Mechanistic Insights From Bronchoscopy Airway Samples

United States24 participantsStarted 2024-07-01

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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
✕. 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
✕. Astemizole: 12 weeks
✕. Steroids (oral, inhaled or nasal): 6 weeks

What they're measuring

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.

Timeframe: 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.

Timeframe: 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.

Timeframe: Between 1-12 weeks

Trial details

NCT IDNCT06105710

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12

Contact for this trial

Christine P Nguyen, BS

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

View on ClinicalTrials.gov More Asthma trials

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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
✕. 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
✕. Astemizole: 12 weeks
✕. Steroids (oral, inhaled or nasal): 6 weeks

What they're measuring

Timeframe: 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.

Timeframe: 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.

Timeframe: Between 1-12 weeks