RECRUITING

Mechanistic Insights From Bronchoscopy Airway Samples

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Mechanistic Insights From Bronchoscopy Airway Samples

Quick Facts

Study Start:2024-07-01

Study Completion:2028-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06105710

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	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 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

Inclusion Criteria

Exclusion 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)

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
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

Contacts and Locations

Study Contact

Devin Roberts, BA

CONTACT

628-233-1233

devin.roberts@ucsf.edu

Christine P Nguyen, BS, CCRP

CONTACT

415-476-3824

christine.nguyen@ucsf.edu

Principal Investigator

Nirav Bhakta, MD, PhD

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Prescott Woodruff, MD, MPH

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco

San Francisco, California, 94143

United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

Nirav Bhakta, MD, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco
Prescott Woodruff, MD, MPH, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-01

Study Completion Date2028-12

Study Record Updates

Study Start Date2024-07-01

Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

Asthma

Additional Relevant MeSH Terms

Asthma