Altered lung biology of healthy never smokers following acute inhalation of E-cigarettes.
Michelle R Staudt, Jacqueline Salit, Robert J Kaner...
https://pubmed.ncbi.nlm.nih.gov/29754582Actively Recruiting
Age: 18Years +
All Genders
Healthy Volunteers
ID01776398
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
Led by Weill Medical College of Cornell University · Updated on 2025-11-14
2000
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
W
Weill Medical College of Cornell University
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are collecting blood, urine, and airway samples from both healthy individuals and those with lung diseases to study genetic expression and other biological factors. The goal is to establish normal ranges for various parameters and compare them with those affected by lung conditions like COPD, IPF, and interstitial lung diseases. This study helps improve understanding of the causes and development of lung diseases by examining changes in airway cells and macrophages before visible disease changes occur. Participants include healthy volunteers and those diagnosed with lung diseases. Samples collected may include blood, urine, nasal and airway brushings, biopsies, or washings. Bronchoscopy is used to gather airway cells in some participants. Clinical patients at certain centers may only provide nasal samples and a small blood sample. All sample collection occurs during separate study visits after informed consent. During the study, participants will provide biological samples and may be followed up with a phone call seven days after their visit. Researchers will analyze genetic material, proteins, and other markers to learn about lung disease causes and progression. The study focuses on comparing data from healthy individuals and lung disease patients, with no additional procedures for some clinical patients. Participation duration varies by visit schedule, and safety is monitored throughout.
CONDITIONS
Brief Title
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Able to provide informed consent
- Males or females aged 18 years and older
- For healthy volunteers: no lung disease; inclusive of all races, ethnicities, sex, HIV status, smoking status, and multiple birth status
- For subjects with lung disease: diagnosis by symptoms, chest X-ray, pulmonary function tests, lung biopsy, family history, or associated organ diseases
- Must provide HIV informed consent
- Cystic fibrosis subjects must be homozygous for the 94F508 mutation with mild to moderate lung disease (FEV1 65 50%)
- Clinical patients must have lung disease as defined above or blood eosinophil levels of 5% or greater
You will not qualify if you...
- Individuals not in good overall health as determined by the investigator
- History of chronic lung disease, including asthma, or recent acute pulmonary disease within 3 months (for healthy volunteers)
- Allergies to atropine, pilocarpine, isoproterenol, terbutaline, aminophylline, lidocaine, versed, valium, or any local anesthetic
- Pregnant or nursing females
- Individuals unable to complete bronchoscopy due to health concerns
- Recent pulmonary exacerbation within 8 weeks for cystic fibrosis subjects
- Patients who refuse consent for clinical patient groups
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Sample Collection
Duration - Single visit
Participants provide blood, urine, and/or airway specimens including nasal samples, airway brushing, biopsy, and/or washings for research studies.
1 visit (in-person)
Follow-up
Duration - 7 days after sample collection
Participants are followed up by a phone call seven days after their sample collection visit to discuss any concerns or outcomes.
1 follow-up phone call
Trial Site Locations
Total: 1 location
1
Weill Cornell Medical College and Weill Cornell Medical Center, Department of Genetic Medicine
New York, New York, United States, 10065-4870
Actively Recruiting
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Research Team
N
Niamh Savage
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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Published Research Related To This Trial
Persistence of circulating endothelial microparticles in COPD despite smoking cessation.
Yael Strulovici-Barel, Michelle R Staudt, Anja Krause...
https://pubmed.ncbi.nlm.nih.gov/27462120