Status:
RECRUITING
Mechanistic Insights From Bronchoscopy Airway Samples
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Asthma
Eligibility:
All Genders
18-70 years
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 pl...
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 pathol...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06105710
Start Date
July 1 2024
End Date
December 1 2028
Last Update
July 23 2024
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94143