Recruiting

Observational Study

Sponsor:

Weill Medical College of Cornell University

Code:

NCT01776398

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Smoking

Smoking Cessation

Idiopathic Pulmonary Fibrosis (IPF)

Rheumatoid Arthritis-Associated Interstitial Lung Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Smoking

Smoking Cessation

Idiopathic Pulmonary Fibrosis (IPF)

Rheumatoid Arthritis-Associated Interstitial Lung Disease

Study ID

NCT01776398

Start date

Aug 29, 2012

Status verified date

Nov, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

1.1 HEALTHY 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.

1.2 SUBJECTS WITH LUNG DISEASE

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)

2. WCMC/NYPH CLINICAL PATIENTS

Subjects may be recruited if subjects fit inclusion/exclusion criteria and are deemed eligible to participate as long as informed consent is given. Sample collection will occur during a separate study visit.

WCMC/NYPH clinical patients will not undergo any additional procedures listed in this protocol as part of this research study.

3. PCNY CLINICAL PATIENTS

Subjects may be recruited if subjects fit inclusion/exclusion criteria and are deemed eligible to participate as long as informed consent is given. Sample collection will occur during a separate study visit. Clinical patients seen at the Pulmonary Consultants of New York will only undergo the nasal sample collection and may be asked to have a blood draw of about 2 teaspoons (9ml).

Primary outcome measure

  • Establishing normal ranges for various parameters [ Time Frame: Participants upon completing the study will be followed up by a phone call seven days after their visit. ]

Central Contacts and Locations

Central contacts

Locations

Weill Cornell Medical College and Weill Cornell Medical Center, Department of Genetic Medicine

Recruiting

New York, New York, United States, 10065-4870

Contacts

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Nov 14, 2025

Last verified

Nov, 2025

Keywords

  • COPD
  • Chronic Obstructive Pulmonary Disease
  • Lung disease
  • Emphysema
  • Smoking
  • Healthy Smoker
  • Smoker
  • Non-smoker
  • IPF
  • RA-ILD
  • SSC-ILD
  • Idiopathic Pulmonary Fibrosis
  • Rheumatoid Arthritis-Associated Interstitial Lung Disease
  • Scleroderma-Associated Interstitial Lung Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2025-11-14.