← Back to Clinical Trials
Recruiting NCT01776398

NCT01776398 Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies

◆ AI Clinical Summary
Plain-language summary for patients
Clinical Trial Summary
NCT ID NCT01776398
Status Recruiting
Phase
Sponsor Weill Medical College of Cornell University
Condition Chronic Obstructive Pulmonary Disease (COPD)
Study Type OBSERVATIONAL
Enrollment 2,000 participants
Start Date 2012-08-29
Primary Completion 2027-12

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type OBSERVATIONAL

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 2,000 participants in total. It began in 2012-08-29 with a primary completion date of 2027-12.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

The purpose of this study is to obtain biologic materials from the blood, airways and/or urine of normal individuals and individuals with lung disease. The normal are used to establish a set of normal ranges for various parameters. These provide control information when compared to individuals with various pulmonary diseases, and will help in understanding of the etiology and pathogenesis of various lung diseases. The underlying hypothesis is that the pathologic morphological changes in the airway epithelium must be preceded by changes in the gene expression pattern of the airway epithelium and potentially in macrophages.

Eligibility Criteria

Inclusion Criteria: Group 1.1 - HEALTHY VOLUNTEER RESEARCH SUBJECTS (Healthy as defined by those not having lung disease and inclusive of: all races, ethnicities, sex, HIV status, smoking status and multiple birth status, etc., within the general population. Smoking status is defined for individuals that may use any of the following: cigarettes, pipes, E-cigarettes, waterpipe, shisha, etc.): * All study subjects should be able to provide informed consent * Males or females ages 18 years and older * Must provide HIV informed consent Group 1.2 - VOLUNTEER RESEARCH SUBJECTS WITH LUNG DISEASE (As defined by those having lung disease or symptoms of lung disease and inclusive of: all races, ethnicities, sex, HIV status, smoking status and multiple birth status, etc., within the general population. Smoking status is defined for individuals that may use any of the following: cigarettes, pipes, E-cigarettes, waterpipe, shisha, etc.): * Must provide informed consent * Males and females age 18 years and older * Lung disease proven by at least one of the following: symptoms consistent with pulmonary disease; (2) chest X-rays consistent with lung disease; (3) pulmonary function tests consistent with lung disease; (4) lung biopsy consistent with lung disease; (5) family history of lung disease; and/or (6) diseases of organs with known association with lung disease * Must provide HIV informed consent Additional Inclusion criteria for CF subjects: • All CF subjects will be homozygous for the ΔF508 mutation, with mild-moderate lung disease as defined by FEV1 ≥ 50% Group 2 - WCMC/NYPH CLINICAL PATIENTS * Must provide informed consent * Males and females, age 18 years and older * Lung disease proven by at least one of the following: (1) symptoms consistent with pulmonary disease; (2) chest X-rays consistent with lung disease; (3) pulmonary function tests consistent with lung disease; (4) lung biopsy consistent with lung disease; (5) family history of lung disease; (6) diseases of organs with known association with lung disease, and (7) individuals with the blood eosinophil levels of 5% or greater. Group 3 - PCNY CLINICAL PATIENTS VOLUNTEER RESEARCH SUBJECTS WITH LUNG DISEASE * Must provide informed consent * Males and females, age 18 years and older * Lung disease proven by at least one of the following: symptoms consistent with pulmonary disease; (2) chest X-rays consistent with lung disease; (3) pulmonary function tests consistent with lung disease; (4) lung biopsy consistent with lung disease; (5) family history of lung disease; and (6) diseases of organs with known association with lung disease Exclusion Criteria: Group 1.1 - HEALTHY VOLUNTEER RESEARCH SUBJECTS * Individuals not deemed in good overall health by the investigator during screening visits and/or prior to the bronchoscopy will not be accepted into the study. * Individuals with history of chronic lung disease, including asthma or with recurrent or recent (within three months) acute pulmonary disease will not be accepted into the study. * Individuals with allergies to atropine or any local anesthetic will not be accepted into the study. * Individuals with allergies to pilocarpine, isoproterenol, terbutaline, atropine or aminophylline will not be accepted into the study. * Females who are pregnant or nursing will not be accepted into the study Group 1.2 - VOLUNTEER RESEARCH SUBJECTS WITH LUNG DISEASE * Any history of allergies to xylocaine, lidocaine, versed, valium, atropine, pilocarpine, isoproterenol, terbutaline, aminophylline, or any local anesthetic will not be included in the study * Individuals deemed unable to complete the bronchoscopy due to health concerns by the investigator. * Females who are pregnant or nursing Additional Exclusion criteria for CF subjects: * Experienced a recent (≤ 8 weeks) pulmonary exacerbation of their disease Group 2 - WCMC/NYPH CLINICAL PATIENTS * Patient refuses consent Group 3 - PCNY CLINICAL PATIENTS * Patient refuses consent

Contact & Investigator

Central Contact

Niamh Savage

✉ nis2049@med.cornell.edu

📞 12127460284

Principal Investigator

Ronald G. Crystal, M.D.

PRINCIPAL INVESTIGATOR

Weill Medical College of Cornell University

Frequently Asked Questions

Who can join the NCT01776398 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Obstructive Pulmonary Disease (COPD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT01776398 currently recruiting?

Yes, NCT01776398 is actively recruiting participants. Contact the research team at nis2049@med.cornell.edu for enrollment information.

Where is the NCT01776398 trial being conducted?

This trial is being conducted at New York, United States.

Who is sponsoring the NCT01776398 clinical trial?

NCT01776398 is sponsored by Weill Medical College of Cornell University. The principal investigator is Ronald G. Crystal, M.D. at Weill Medical College of Cornell University. The trial plans to enroll 2,000 participants.

Related Trials

Related Intelligence Guides

In-depth guides covering this condition's trials, eligibility, and what to expect.

ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: April 2026  ·  Data Methodology