Chronic Airway DiseaseNCT03295279
WTC Chest CT Imaging Archive
An observational study of Chronic Airway Disease and Interstitial Lung Disease, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Dr. Rafael E de la Hoz and colleagues have performed standardized and computer-assisted readings of all chest CT scans received by WTC workers and volunteers at the Mount Sinai Medical Center between 2003 and 2016. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Airway Disease, Interstitial Lung Disease, Lung Cancer
- How many people
- 2,122 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2012to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All subjects will be participants in the screening/monitoring (SMP) and treatment program (TP) sides of the WTC Health Plan Clinical Center Excellence at Mount Sinai Medical Center, the major site, by far of the NY/NJ consortium of this program.
Who may be able to join
- All subjects will be participants in the screening/monitoring (SMP) and treatment program (TP) sides of the WTC Health Plan Clinical Center Excellence at Mount Sinai Medical Center, the major site, by far of the NY/NJ consortium of this program.
Who cannot join
- Special vulnerable populations, such as fetuses, neonates, pregnant women, children, prisoners, institutionalized individuals, will not be involved in this research study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Pulmonary Diseases in WTC Workers: Symptoms, Function, and Chest CT Correlates
Dr. Rafael E de la Hoz and colleagues have performed standardized and computer-assisted readings of all chest CT scans received by WTC workers and volunteers at the Mount Sinai Medical Center between 2003 and 2016. The clinical team sought to assess all findings suggestive of airway, interstitial, and neoplastic disease in a systematic way, and correlate those findings with clinical, functional, and exposure indicators. The study team's research will also involve analyses of longitudinal imaging and functional trends, and characterization of the WTC related lower airway diseases and their risk factors, with a focus on obesity-related imaging markers. The study team also plans to characterize the transitions into chronic obstructive pulmonary disease (COPD) among these workers.
The researchers also propose to test the use of added respiratory surveillance tools and explore functional markers of disease progression, explore alternate methods to investigate longitudinal functional trajectories, and novel spirometry calibration methods that might facilitate the implementation of spirometry in nonspecialized settings.
Read the detailed description
The goal of this proposal is to characterize WTC-related lower airway disorders, and use novel imaging approaches to the investigation of obesity, one of their most important risk factors for poor clinical outcome and chronicity. To that end, the clinical team will utilize the WTC Pulmonary Evaluation Unit Chest CT Imaging Archive, an already established large imaging database, linked to extensive related databases that include disease symptoms, both pre-WTC and WTC-related occupational exposures, detailed pulmonary function and longitudinal spirometry measurements, visual imaging classification and grading, and quantitative computer assisted method (QCAM) measurements of airway, pulmonary parenchymal, pleural, and cardiovascular abnormalities. During the course of the proposed research project, the clinical team will continue to enrich most sources of data with periodic updates, in order to accrue information on the trajectories of the different clinical, functional, and imaging abnormalities observed in this population, and investigate the role of key adverse risk factors directly, and in collaboration with other investigators. In a related project, the research team will focus on COPD, classifying its severity, investigating its diagnostic stability, progression, and transitions, characterize structural abnormalities as assessed by chest CT imaging, and examine the interaction of WTC-related exposure levels with tobacco smoking on increasing the risk of for the disease.
Grant U01 OH010401 was renewed to 6/30/2026.
Grant U01 OH011697 proposes (1) to establish the quantitative computed tomography (QCT) characteristics that may differentiate WTC-related from non-WTC-related COPD, (2) investigate characteristics and longitudinal lung function trajectories of WTC patients with pre-COPD, and (3) investigate lung mechanical strain (LMS) as an early QCT marker of lung injury associated with chronic disease and accelerated longitudinal lung function decline.
Grant U01 OH012782-01-00 proposes (1) to test the use of added respiratory surveillance tools (diffusion capacity and forced oscillometry) and explore functional markers of disease progression, (2) explore alternate methods to investigate longitudinal functional trajectories, and (3) novel spirometry calibration methods that might facilitate the implementation of spirometry in nonspecialized settings.
- Keywords
- World Trade Center, Quantitative computerized tomography, Qualitative computerized tomography of the chest, Chronic airway disease, Interstitial lung disease, Occupational pulmonology, Spirometry, Forced Oscillometry
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial, Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Accelerated longitudinal FEV1 decline
The clinical team selects spirometries of acceptable quality, and subjects with at least 3 spirometries spanning at least 5 years, to calculate FEV1 slope, which can then be modeled quantitatively. For categorical analyses, the clinical team defines rapid FEV1 decliners and contrast them to normal-and-stable FEV1 subjects, defined as those having an FEV1 above the lower limit of normal at baseline, no bronchodilator response, and FEV1 not changing by more than 25 ml/year on average in either direction.
Measured: 5 years
Secondary outcomes (1)
Number of physician diagnosis of incident asthma
Physician diagnosis of asthma with onset after WTC occupational exposures.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study start1 Sep 2012
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Chronic Airway DiseaseStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh, Brigham and Women's Hospital, National Jewish Health
- Responsible party
- Principal investigator, Rafael E. de la Hoz, Icahn School of Medicine at Mount Sinai
- Investigators
- Rafael E. de la Hoz, MD, MPH, MSc, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295279
- Sponsor's protocol ID
- GCO 12-0751
- Other IDs
- U01OH010401, U01OH011697, GCO 17-2598, U01OH012782, GCO 23-2259
- Status last verified
- Apr 2026
- First submitted
- 25 Sep 2017
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de la Hoz RE, Shohet MR, Chasan R, Bienenfeld LA, Afilaka AA, Levin SM, Herbert R. Occupational toxicant inhalation injury: the World Trade Center (WTC) experience. Int Arch Occup Environ Health. 2008 Feb;81(4):479-85. doi: 10.1007/s00420-007-0240-x. Epub 2007 Sep 5.
PubMed 17786467Mendelson DS, Roggeveen M, Levin SM, Herbert R, de la Hoz RE. Air trapping detected on end-expiratory high-resolution computed tomography in symptomatic World Trade Center rescue and recovery workers. J Occup Environ Med. 2007 Aug;49(8):840-5. doi: 10.1097/JOM.0b013e3180d09e87.
PubMed 17693781de la Hoz RE, Liu X, Doucette JT, Reeves AP, Bienenfeld LA, Wisnivesky JP, Celedon JC, Lynch DA, San Jose Estepar R. Increased Airway Wall Thickness is Associated with Adverse Longitudinal First-Second Forced Expiratory Volume Trajectories of Former World Trade Center workers. Lung. 2018 Aug;196(4):481-489. doi: 10.1007/s00408-018-0125-7. Epub 2018 May 24.
PubMed 29797069Weber J, Reeves AP, Doucette JT, Jeon Y, Sood A, San Jose Estepar R, Celedon JC, de la Hoz RE. Quantitative CT Evidence of Airway Inflammation in WTC Workers and Volunteers with Low FVC Spirometric Pattern. Lung. 2020 Jun;198(3):555-563. doi: 10.1007/s00408-020-00350-5. Epub 2020 Apr 1.
PubMed 32239319Liu X, Reeves AP, Antoniak K, San Jose Estepar R, Doucette JT, Jeon Y, Weber J, Xu D, Celedon JC, de la Hoz RE. Association of quantitative CT lung density measurements and lung function decline in World Trade Center workers. Clin Respir J. 2021 Jun;15(6):613-621. doi: 10.1111/crj.13313. Epub 2020 Dec 29.
PubMed 33244876de la Hoz RE, Shapiro M, Nolan A, Sood A, Lucchini RG, Cone JE, Celedon JC. Association of World Trade Center (WTC) Occupational Exposure Intensity with Chronic Obstructive Pulmonary Disease (COPD) and Asthma COPD Overlap (ACO). Lung. 2023 Aug;201(4):325-334. doi: 10.1007/s00408-023-00636-4. Epub 2023 Jul 19.
PubMed 37468611de la Hoz RE, Jeon Y, Doucette JT, Reeves AP, San Jose Estepar R, Celedon JC. Cluster Analysis of World Trade Center Related Lower Airway Diseases. J Occup Environ Med. 2024 Feb 1;66(2):179-184. doi: 10.1097/JOM.0000000000003023. Epub 2023 Nov 29.
PubMed 38305727Weber J, Zhang Z, Doucette JT, Sood A, Celedon JC, de la Hoz RE. Spirometric pattern transitions in a World Trade Center occupational cohort on longitudinal surveillance. Respir Med. 2025 Aug;244:108170. doi: 10.1016/j.rmed.2025.108170. Epub 2025 May 21.
PubMed 40409739Zhang Z, San Jose Estepar R, Doucette JT, Weber J, Ross JC, Celedon JC, de la Hoz RE. Quantitative CT metrics of injury patterns among WTC workers on different longitudinal FEV1 trajectory groups. Respir Med. 2026 May;256:108810. doi: 10.1016/j.rmed.2026.108810. Epub 2026 Apr 7.
PubMed 41956171Napier CO, Mbadugha O, Bienenfeld LA, Doucette JT, Lucchini R, Luna-Sanchez S, de la Hoz RE. Obesity and weight gain among former World Trade Center workers and volunteers. Arch Environ Occup Health. 2017 Mar 4;72(2):106-110. doi: 10.1080/19338244.2016.1197174. Epub 2016 Jun 7.
PubMed 27268046de la Hoz RE, Jeon Y, Miller GE, Wisnivesky JP, Celedon JC. Post-traumatic Stress Disorder, Bronchodilator Response, and Incident Asthma in World Trade Center Rescue and Recovery Workers. Am J Respir Crit Care Med. 2016 Dec 1;194(11):1383-1391. doi: 10.1164/rccm.201605-1067OC.
PubMed 27548615de la Hoz RE, Weber J, Xu D, Doucette JT, Liu X, Carson DA, Celedon JC. Chest CT scan findings in World Trade Center workers. Arch Environ Occup Health. 2019;74(5):263-270. doi: 10.1080/19338244.2018.1452712. Epub 2018 May 9.
PubMed 29543564de la Hoz RE, Jeon Y, Reeves AP, San Jose Estepar R, Liu X, Doucette JT, Celedon JC, Nolan A. Increased pulmonary artery diameter is associated with reduced FEV1 in former World Trade Center workers. Clin Respir J. 2019 Oct;13(10):614-623. doi: 10.1111/crj.13067. Epub 2019 Aug 19.
PubMed 31347281de la Hoz RE, Liu X, Celedon JC, Doucette JT, Jeon Y, Reeves AP, San Jose Estepar R. Association of Obesity with Quantitative Chest CT Measured Airway Wall Thickness in WTC Workers with Lower Airway Disease. Lung. 2019 Aug;197(4):517-522. doi: 10.1007/s00408-019-00246-z. Epub 2019 Jun 28.
PubMed 31254057de la Hoz RE. Occupational lower airway disease in relation to World Trade Center inhalation exposure. Curr Opin Allergy Clin Immunol. 2011 Apr;11(2):97-102. doi: 10.1097/ACI.0b013e3283449063.
PubMed 21325944
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Diseases in WTC Workers: Symptoms, Function, and Chest CT Correlates
- ClinicalTrials.gov ID
- NCT03295279
- Acronym / sponsor ID
- GCO 12-0751
- Keywords
- World Trade Center, Quantitative computerized tomography, Qualitative computerized tomography of the chest, Chronic airway disease, Interstitial lung disease, Occupational pulmonology, Spirometry, Forced Oscillometry
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,122 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- University of Pittsburgh, Brigham and Women's Hospital, National Jewish Health
- Study start
- 1 Sep 2012 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 27 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dr. Rafael E de la Hoz and colleagues have performed standardized and computer-assisted readings of all chest CT scans received by WTC workers and volunteers at the Mount Sinai Medical Center between 2003 and 2016. The clinical team sought to assess all findings suggestive of airway, interstitial, and neoplastic disease in a systematic way, and correlate those findings with clinical, functional, and exposure indicators. The study team's research will also involve analyses of longitudinal imaging and functional trends, and characterization of the WTC related lower airway diseases and their risk factors, with a focus on obesity-related imaging markers. The study team also plans to characterize the transitions into chronic obstructive pulmonary disease (COPD) among these workers.
The researchers also propose to test the use of added respiratory surveillance tools and explore functional markers of disease progression, explore alternate methods to investigate longitudinal functional trajectories, and novel spirometry calibration methods that might facilitate the implementation of spirometry in nonspecialized settings.
Detailed description
The goal of this proposal is to characterize WTC-related lower airway disorders, and use novel imaging approaches to the investigation of obesity, one of their most important risk factors for poor clinical outcome and chronicity. To that end, the clinical team will utilize the WTC Pulmonary Evaluation Unit Chest CT Imaging Archive, an already established large imaging database, linked to extensive related databases that include disease symptoms, both pre-WTC and WTC-related occupational exposures, detailed pulmonary function and longitudinal spirometry measurements, visual imaging classification and grading, and quantitative computer assisted method (QCAM) measurements of airway, pulmonary parenchymal, pleural, and cardiovascular abnormalities. During the course of the proposed research project, the clinical team will continue to enrich most sources of data with periodic updates, in order to accrue information on the trajectories of the different clinical, functional, and imaging abnormalities observed in this population, and investigate the role of key adverse risk factors directly, and in collaboration with other investigators. In a related project, the research team will focus on COPD, classifying its severity, investigating its diagnostic stability, progression, and transitions, characterize structural abnormalities as assessed by chest CT imaging, and examine the interaction of WTC-related exposure levels with tobacco smoking on increasing the risk of for the disease.
Grant U01 OH010401 was renewed to 6/30/2026.
Grant U01 OH011697 proposes (1) to establish the quantitative computed tomography (QCT) characteristics that may differentiate WTC-related from non-WTC-related COPD, (2) investigate characteristics and longitudinal lung function trajectories of WTC patients with pre-COPD, and (3) investigate lung mechanical strain (LMS) as an early QCT marker of lung injury associated with chronic disease and accelerated longitudinal lung function decline.
Grant U01 OH012782-01-00 proposes (1) to test the use of added respiratory surveillance tools (diffusion capacity and forced oscillometry) and explore functional markers of disease progression, (2) explore alternate methods to investigate longitudinal functional trajectories, and (3) novel spirometry calibration methods that might facilitate the implementation of spirometry in nonspecialized settings.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects will be participants in the screening/monitoring (SMP) and treatment program (TP) sides of the WTC Health Plan Clinical Center Excellence at Mount Sinai Medical Center, the major site, by far of the NY/NJ consortium of this program.
Key inclusion criteria (1 listed)
- All subjects will be participants in the screening/monitoring (SMP) and treatment program (TP) sides of the WTC Health Plan Clinical Center Excellence at Mount Sinai Medical Center, the major site, by far of the NY/NJ consortium of this program.
Key exclusion criteria (1 listed)
- Special vulnerable populations, such as fetuses, neonates, pregnant women, children, prisoners, institutionalized individuals, will not be involved in this research study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accelerated longitudinal FEV1 decline
Time frame: 5 years
The clinical team selects spirometries of acceptable quality, and subjects with at least 3 spirometries spanning at least 5 years, to calculate FEV1 slope, which can then be modeled quantitatively. For categorical analyses, the clinical team defines rapid FEV1 decliners and contrast them to normal-and-stable FEV1 subjects, defined as those having an FEV1 above the lower limit of normal at baseline, no bronchodilator response, and FEV1 not changing by more than 25 ml/year on average in either direction.
1 secondary outcome
Number of physician diagnosis of incident asthma
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Background: PubMed 17786467de la Hoz RE, Shohet MR, Chasan R, Bienenfeld LA, Afilaka AA, Levin SM, Herbert R. Occupational toxicant inhalation injury: the World Trade Center (WTC) experience. Int Arch Occup Environ Health. 2008 Feb;81(4):479-85. doi: 10.1007/s00420-007-0240-x. Epub 2007 Sep 5.
- Background: PubMed 17693781Mendelson DS, Roggeveen M, Levin SM, Herbert R, de la Hoz RE. Air trapping detected on end-expiratory high-resolution computed tomography in symptomatic World Trade Center rescue and recovery workers. J Occup Environ Med. 2007 Aug;49(8):840-5. doi: 10.1097/JOM.0b013e3180d09e87.
- Results publication: PubMed 29797069de la Hoz RE, Liu X, Doucette JT, Reeves AP, Bienenfeld LA, Wisnivesky JP, Celedon JC, Lynch DA, San Jose Estepar R. Increased Airway Wall Thickness is Associated with Adverse Longitudinal First-Second Forced Expiratory Volume Trajectories of Former World Trade Center workers. Lung. 2018 Aug;196(4):481-489. doi: 10.1007/s00408-018-0125-7. Epub 2018 May 24.
- Results publication: PubMed 32239319Weber J, Reeves AP, Doucette JT, Jeon Y, Sood A, San Jose Estepar R, Celedon JC, de la Hoz RE. Quantitative CT Evidence of Airway Inflammation in WTC Workers and Volunteers with Low FVC Spirometric Pattern. Lung. 2020 Jun;198(3):555-563. doi: 10.1007/s00408-020-00350-5. Epub 2020 Apr 1.
- Results publication: PubMed 33244876Liu X, Reeves AP, Antoniak K, San Jose Estepar R, Doucette JT, Jeon Y, Weber J, Xu D, Celedon JC, de la Hoz RE. Association of quantitative CT lung density measurements and lung function decline in World Trade Center workers. Clin Respir J. 2021 Jun;15(6):613-621. doi: 10.1111/crj.13313. Epub 2020 Dec 29.
- Results publication: PubMed 37468611de la Hoz RE, Shapiro M, Nolan A, Sood A, Lucchini RG, Cone JE, Celedon JC. Association of World Trade Center (WTC) Occupational Exposure Intensity with Chronic Obstructive Pulmonary Disease (COPD) and Asthma COPD Overlap (ACO). Lung. 2023 Aug;201(4):325-334. doi: 10.1007/s00408-023-00636-4. Epub 2023 Jul 19.
- Results publication: PubMed 38305727de la Hoz RE, Jeon Y, Doucette JT, Reeves AP, San Jose Estepar R, Celedon JC. Cluster Analysis of World Trade Center Related Lower Airway Diseases. J Occup Environ Med. 2024 Feb 1;66(2):179-184. doi: 10.1097/JOM.0000000000003023. Epub 2023 Nov 29.
- Results publication: PubMed 40409739Weber J, Zhang Z, Doucette JT, Sood A, Celedon JC, de la Hoz RE. Spirometric pattern transitions in a World Trade Center occupational cohort on longitudinal surveillance. Respir Med. 2025 Aug;244:108170. doi: 10.1016/j.rmed.2025.108170. Epub 2025 May 21.
- Results publication: PubMed 41956171Zhang Z, San Jose Estepar R, Doucette JT, Weber J, Ross JC, Celedon JC, de la Hoz RE. Quantitative CT metrics of injury patterns among WTC workers on different longitudinal FEV1 trajectory groups. Respir Med. 2026 May;256:108810. doi: 10.1016/j.rmed.2026.108810. Epub 2026 Apr 7.
- Results publication: PubMed 27268046Napier CO, Mbadugha O, Bienenfeld LA, Doucette JT, Lucchini R, Luna-Sanchez S, de la Hoz RE. Obesity and weight gain among former World Trade Center workers and volunteers. Arch Environ Occup Health. 2017 Mar 4;72(2):106-110. doi: 10.1080/19338244.2016.1197174. Epub 2016 Jun 7.
- Results publication: PubMed 27548615de la Hoz RE, Jeon Y, Miller GE, Wisnivesky JP, Celedon JC. Post-traumatic Stress Disorder, Bronchodilator Response, and Incident Asthma in World Trade Center Rescue and Recovery Workers. Am J Respir Crit Care Med. 2016 Dec 1;194(11):1383-1391. doi: 10.1164/rccm.201605-1067OC.
- Results publication: PubMed 29543564de la Hoz RE, Weber J, Xu D, Doucette JT, Liu X, Carson DA, Celedon JC. Chest CT scan findings in World Trade Center workers. Arch Environ Occup Health. 2019;74(5):263-270. doi: 10.1080/19338244.2018.1452712. Epub 2018 May 9.
- Principal investigator's ORCID recordLink provided by the sponsor.
- Principal investigator's WTC-related bibliographyLink provided by the sponsor.
- Principal investigator's RePORT site for Study 24-00850Link provided by the sponsor.
- Principal investigator's RePORT site for Study 12-00925Link provided by the sponsor.
- Principal investigator's RePORT site for Study 18-00595Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Chronic Airway Disease
Recruiting
Lungs on Fire: Wildfire Smoke, Incident Diseases, Susceptible Populations, and Community Values in Canada
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruitingPhase 3
Study of Fluticasone/Formoterol/Glycopyrronium for the Treatment Chronic Obstructive Pulmonary Disease (TRIPLAR)
Chronic Obstructive Pulmonary Disease
RecruitingObservational study
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
Chronic Obstructive Pulmonary Disease (COPD), Smoking
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rafael E. de la Hoz, MD, MPH, MSc principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Airway Disease and Interstitial Lung Disease, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accelerated longitudinal FEV1 decline (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03295279, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.