RecruitingNCT06105710
Mechanistic Insights From Bronchoscopy Airway Samples
Sponsor
University of California, San Francisco
Enrollment
24 participants
Start Date
Jul 1, 2024
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Min Age: 18 YearsMax Age: 70 Years
Inclusion Criteria11
- 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 Criteria18
- 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
- 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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06105710
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