Examining the mechanisms of asthma through airway samples

Mechanistic Insights From Bronchoscopy Airway Samples

This study looks at airway samples from people with and without asthma to see how certain immune responses affect mucus production and contribute to asthma symptoms.

Quick facts

• Study type: Observational
• Enrollment: 24 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: University of California, San Francisco (Academic / other)
• Drugs / interventions: Omalizumab
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT06105710 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the cellular mechanisms involved in asthma by comparing airway samples from individuals with and without the condition. The UCSF Airway Clinical Research Center focuses on understanding how type 2 immune responses affect epithelial cells, leading to mucus production and secretion, which are critical in severe asthma pathology. The study will explore novel molecular mechanisms that influence secretory cell differentiation and mucus dysfunction, contributing to airway obstruction. By analyzing these mechanisms, the research seeks to provide insights into the pathogenesis of severe asthma.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 70 with a history of asthma or healthy controls without respiratory issues.

Not a fit: Patients who are current smokers or have a significant smoking history may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and treatment options for patients with severe asthma.

How similar studies have performed: Other studies have shown success in understanding asthma mechanisms, but this research focuses on novel pathways that have not been extensively explored.

Eligibility criteria

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.

Where this trial is running

San Francisco, California

• University of California, San Francisco — San Francisco, California, United States (Recruiting)

Study contacts

• Principal investigator: Nirav Bhakta, MD, PhD — University of California, San Francisco
• Study coordinator: Christine P Nguyen, BS

Conditions Asthma