Study of COPD Subgroups and Biomarkers (SPIROMICS)

November 12, 2025 updated by: University of North Carolina, Chapel Hill

Subpopulations and Intermediate Outcome Measures in COPD Study

SPIROMICS I, SPIROMICS II, and SPIROMICS III are longitudinal observational studies of Chronic Obstructive Pulmonary Disease (COPD) cohort.

SPIROMICS I had two primary aims: (1) To find groups of patients with COPD who share certain characteristics; (2) To find new ways of measuring whether or not COPD is getting worse and to provide new ways of testing whether a new treatment is working.

SPIROMICS II had three primary aims: (1) To define the natural history of "smokers with symptoms despite preserved spirometry" and characterize the airway mucus abnormalities underlying this condition; (2) To determine the radiographic precursor lesion(s) for emphysema and identify the molecular phenotypes underlying airway disease and emphysema; (3) To advance understanding of the biology of COPD exacerbations through analysis of predisposing baseline phenotypes, exacerbation triggers and host inflammatory response.

SPIROMICS III has three primary aims: (1) To identify the main forms of smoking-related airway disease that are caused by pathological airway mucus, their biological underpinnings, and their physiological significance; (2) To identify longitudinal trajectories in established and novel CT measures of emphysema, test how they predict COPD progression, and define their underlying biology; (3) To identify environmental and social determinants of health that impact disease severity and progression and their influence on lung structure, biology, and health disparities in COPD.

Study Overview

Status

Active, not recruiting

Detailed Description

SPIROMICS was initially funded through contracts from the NIH. That phase of SPIROMICS is now referred to as SPIROMICS I. SPIROMICS II was funded as a grant from the NIH to continue the longitudinal observation of the SPIROMICS cohort recruited in SPIROMICS I. The current phase, referred to as SPIROMICS III, is funded through a contract from the NIH to continue the longitudinal observation of the SPIROMICS cohort that remain active (not withdrawn, lost to follow-up, or deceased).

Description of SPIROMICS I:

The purpose of SPIROMICS was to learn about chronic obstructive pulmonary disease (COPD), which is sometimes called emphysema or chronic bronchitis. Millions of Americans have COPD, and it is the fourth leading cause of death in the country. The most common cause of COPD is cigarette smoking, although not all smokers get COPD. The discovery of new treatments for COPD has been slowed by a poor understanding of different types of COPD and a lack of ways to measure whether or not COPD is getting worse.

The study had two main goals. The first was to find groups of patients with COPD who share certain characteristics. Certain groups may respond differently to certain treatments. The second was to find new ways of measuring whether or not COPD is getting worse. This would provide new ways of testing whether a new treatment is working.

SPIROMICS I had three sub studies and two key ancillary studies.

Sub studies:

  1. Repeatability Substudy: The entire baseline clinic visit was repeated on 100 participants on a volunteer basis. The goal of this substudy was to determine reliability of measurement procedures.
  2. Bronchoscopy Substudy: ~300 participants were enrolled for two additional study visits, including a bronchoscopy. The goal of this substudy was to collect and assess biological specimens and relate those results to clinical measurements.
  3. Exacerbation Substudy: ~400 participants were enrolled in this substudy. A daily symptom diary was collected on all participants. Participants were also seen in the clinic during a pulmonary exacerbation. The goals of this substudy were to 1) better understand the relationship between symptoms and exacerbations and 2) obtain clinical data and specimens during a pulmonary exacerbation.

Ancillary Studies:

  1. Air Pollution Ancillary Study: The SPIROMICS Air Pollution ancillary study used state-of-the art air pollution exposure assessments to determine individual-level outdoor and indoor air pollution exposure. The goals of this substudy were to determine the effect of long-term air pollution exposure on COPD morbidity and to determine whether short-term changes in outdoor air pollution are associated with changes in COPD morbidity.
  2. Parametric Response Mapping in COPD: The Parametric Response Mapping (PRM) in COPD ancillary study collected an additional CT scan during the final study visit and used a new analysis technique (PRM) to assess the functional small airways of the lung and emphysema.

Description of SPIROMICS II:

Aim 1 was to define the natural history of "smokers with symptoms despite preserved spirometry" and characterize the airway mucus abnormalities underlying this condition. Aim 2 was to determine the radiographic precursor lesion(s) for emphysema and identify the molecular phenotypes underlying airway disease and emphysema. Aim 3 was to advance understanding of the biology of COPD exacerbations through analysis of predisposing baseline phenotypes, exacerbation triggers and host inflammatory response.

SPIROMICS II continued follow-up of active participants, with no new enrollment. Each participant had one clinic visit at 5-7 years of follow-up from SPIROMICS I baseline and was contacted by telephone every 4 months to assess respiratory health status.

Description of SPIROMICS III:

Aim 1 is to identify the main forms of smoking-related airway disease that are caused by pathological airway mucus, their biological underpinnings, and their physiological significance. Aim 2 is to identify longitudinal trajectories in established and novel CT measures of emphysema, test how they predict COPD progression, and define their underlying biology. Aim 3 is to identify environmental and social determinants of health that impact disease severity and progression and their influence on lung structure, biology, and health disparities in COPD.

SPIROMICS III will enroll and consent approximately 1800 participants to conduct (a) a single in-person clinic visit at approximately 11-16 years of follow-up for those originally enrolled into SPIROMICS I and approximately 5-6 years of follow-up for those originally enrolled into SOURCE (and MAP COPD) (NCT05033990), (b) follow-up telephone calls every 4 months to assess respiratory health status, and (c) to assess indoor and outdoor environmental monitoring.

Study Type

Observational

Enrollment (Actual)

2981

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Birmingham, Alabama, United States, 35249
        • University of Alabama at Birmingham
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic Arizona
    • California
      • Los Angeles, California, United States, 90095
        • University of California at Los Angeles
      • San Francisco, California, United States, 94143
        • University of California at San Francisco
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Health
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins University
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • New York
      • New York, New York, United States, 10032
        • Columbia University
      • New York, New York, United States, 10021
        • Weill Cornell Medicine
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah

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.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Never-smokers, current and former smokers without COPD, and current and former smokers with COPD with access to one of the study clinical centers.

Description

Inclusion Criteria:

  • Between 40 and 80 at baseline visit
  • Never smokers: <1 pack-year history of smoking
  • Never smokers: Must meet lung function criteria based on spirometry without inhaled bronchodilators
  • Current or former smokers: >20 pack-year history of smoking
  • Current or former smokers: Must meet lung function criteria based on spirometry with inhaled bronchodilators

Exclusion Criteria:

  • Dementia or other cognitive dysfunction which in the opinion of the investigator would prevent the participant from consenting to the study or completing study procedures
  • Plans to leave the area in the next 3 years
  • Smoking history of > 1 pack-year but <21 pack-years
  • BMI > 40 kg/m2 at baseline exam
  • Prior significant difficulties with pulmonary function testing
  • Hypersensitivity to or intolerance of albuterol sulfate or ipratropium bromide or propellants or excipients of the inhalers
  • Non-COPD obstructive lung disease, severe kyphoscoliosis, neuromuscular weakness, or other conditions, including clinically significant cardiovascular and pulmonary disease, that, limit the interpretability of the pulmonary function measures.
  • History of Interstitial lung disease
  • History of Lung volume reduction surgery or lung resection
  • History of lung or other organ transplant
  • History of endobronchial valve therapy
  • History of large thoracic metal implants (e.g., AICD (automatic implantable cardioverter/defibrillator) and/or pacemaker)
  • Currently taking >=10mg a day/20mg every other day of prednisone or equivalent systemic corticosteroid
  • Currently taking any immunosuppressive agent
  • Current illicit substance abuse, excluding marijuana
  • History of or current use of IV Ritalin
  • History of or current use of heroin
  • History of illegal IV drug use within the last 10 years or more than 5 instances of illegal IV drug use ever
  • Known HIV/AIDS infection
  • History of lung cancer or any cancer that spread to multiple locations in the body
  • History of or current exposure to chemotherapy or radiation treatments that, in the opinion of the investigator, limits the interpretability of the pulmonary function measures.
  • Diagnosis of unstable cardiovascular disease including myocardial infarction in the past 6 weeks, uncontrolled congestive heart failure, or uncontrolled arrhythmia
  • Any illness expected to cause mortality in the next 3 years
  • Active pulmonary infection, including tuberculosis
  • History of pulmonary embolism in the past 2 years
  • Known diagnosis of primary bronchiectasis
  • Currently institutionalized (e.g., prisons, long-term care facilities)
  • Known to be a first degree relative of another, already enrolled participant (i.e., biological parent, biological sibling)
  • Never smokers only: Current diagnosis of asthma
  • Women only: Cannot be pregnant at baseline or plan to become pregnant during the course of the study

Temporal Exclusion Criteria for SPIROMICS III:

  • Participants who present with a pulmonary exacerbation, either solely participant-identified or that has been clinically treated, in the last six weeks, can complete the study visit once a six-week window has passed.
  • Participants who present with an upper respiratory infection, either solely participant-identified or that has been clinically treated, in the last six weeks, can complete the study visit once a six-week window has passed.
  • Participants who present with current use of acute antibiotics or steroids can complete the study visit ≥30 days after discontinuing acute antibiotics/steroids. This does not apply to participants who are on chronic prednisone therapy of <10 mg per day or <20 mg every other day or participants who are currently on chronic, prophylactic, or suppressive antibiotic therapy.
  • Participants who present with a myocardial infarction or eye, chest or abdominal surgery within six weeks can complete the study visit after a six-week window has passed.
  • Female participants who present <3 months after giving birth will be asked to schedule the visit once three months have passed post-delivery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Smokers without COPD
Current or former smokers with at least a 20 pack-year history with normal lung function based on post-bronchodilator spirometry (n=944).
Severe COPD
Current and former smokers with at least a 20 pack-year history with severe COPD based on post-bronchodilator spirometry (n=625).
Mild/Moderate COPD
Current and former smokers with at least a 20 pack-year history with mild to moderate COPD based on post-bronchodilator spirometry (n=1210).
Non-smokers
Never-smokers with normal lung function on spirometry without use of bronchodilators (n=201).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity
Time Frame: Through study completion, an average of 18 years.
Morbidity in SPIROMICS will primarily be measured by assessing acute exacerbations in the SPIROMICS cohort.
Through study completion, an average of 18 years.
Lung Function
Time Frame: Through study completion, an average of 18 years.
COPD is characterized by physiological problems, such as airflow limitations and abnormalities of gas exchange and lung hyperinflation. These features of lung function are accessed objectively in the laboratory setting using spirometry/plethysmography, which can measure such parameters as FEV1 (forced expiratory volume in one second), FVC (forced vital capacity or total volume of air exhaled after full inspiration), FRC (functional residual capacity or volume of gas remaining in the lung at the end of tidal expiration), and IC (inspiratory capacity or maximum volume of gas that can be inspired from end-tidal expiration). The FDA preferred primary endpoint for assessment of alteration in disease progression in COPD is serial measurements of FEV1 over three years.
Through study completion, an average of 18 years.
Mortality
Time Frame: Through study completion, an average of 18 years.
Deaths of SPIROMICS participants will be identified during follow-up calls and attempts to schedule clinic exams during the three-year study period, and deaths will be recorded in the clinical database. The cause of death will be determined via chart review and adjudication, and deaths attributable to COPD worsening or exacerbation will be recorded as confirmed clinical endpoints, in addition to contributing to the endpoint of all-cause mortality.
Through study completion, an average of 18 years.
SPIROMICS III: Radiology - Emphysema Volume
Time Frame: Through study completion, an average of 18 years.
Percent Emphysema (percent <-950HU)
Through study completion, an average of 18 years.
SPIROMICS III: Radiology - Functional Small Airway Disease through Parametric Response Mapping (PRM)
Time Frame: Through study completion, an average of 18 years.
PRM metrics will be used to non-invasively evaluate the regional structural heterogeneity of the lung, including small airways disease and emphysema, and its relationship to clinical measurements. The metric is PRMfSAD.
Through study completion, an average of 18 years.
SPIROMICS III: Radiology - Functional Small Airway Disease through Disease Probability Method (DPM)
Time Frame: Through study completion, an average of 18 years.
Patients undergo both full-inspiration and full-expiration chest CT scans. These scans are coregistered-aligned voxel-by-voxel-to allow for direct comparison of lung tissue characteristics between breathing phases. Each voxel (3D pixel) in the lung is classified into one of three categories: Normal: No signs of disease, Emphysema: Identified by low attenuation on inspiratory CT, Gas Trapping (SAD): Identified by abnormal retention of air on expiratory CT without emphysema features. The proportion of voxels classified as emphysema, gas trapping, or normal is calculated.
Through study completion, an average of 18 years.
SPIROMICS III: Radiology - Airway Wall Thickness
Time Frame: Through study completion, an average of 18 years.
Pi10 as a measure of airway wall thickness
Through study completion, an average of 18 years.
SPIROMICS III: Physiology - Lung function (Spirometry)
Time Frame: Through study completion, an average of 18 years.
Lung function will be assessed as FEV1 through spirometry using forced and slow vital capacity before and after bronchodilator (BD) administration.
Through study completion, an average of 18 years.
SPIROMICS III: Physiology - Lung function (Respiratory Oscillometry)
Time Frame: Through study completion, an average of 18 years.
Assessment of lung function through respiratory oscillometry.
Through study completion, an average of 18 years.
SPIROMICS III: Biological - Mucin concentrations
Time Frame: Through study completion, an average of 18 years.
Mucus samples obtained from sputum, bronchial brushings, and Bronchoalveolar Lavage (BAL) will be analyzed for total mucin concentration.
Through study completion, an average of 18 years.
SPIROMICS III: Biological - MUCQ index
Time Frame: Through study completion, an average of 18 years.
The MUCQ index which integrates mucin concentration with MUC5AC/MUC5B ratios will be calculated and provide more detailed understanding of mucin composition and regulation. The formula MUCQ=[total mucin] x [5AC]/[MUC5B] / 100 will be used.
Through study completion, an average of 18 years.
SPIROMICS III: Biological - Mucin-interacting proteins
Time Frame: Through study completion, an average of 18 years.
Mucin-interacting proteins will be identified and quantified using labeled and label free mass spectrometry.
Through study completion, an average of 18 years.
SPIROMICS III: Environmental and Social Determinants of Health - Outdoor concentrations of particulate matter (PM) 2.5
Time Frame: Through study completion, an average of 18 years.
Data on ambient air quality will be obtained from the EPA DataMart for sites nearest each participant home address. Data will be obtained at the highest temporal resolution and averaged to daily and weekly values. Outdoor concentrations of PM2.5 will be measured in micrograms per cubic meter of air (µg/m³).
Through study completion, an average of 18 years.
SPIROMICS III: Environmental and Social Determinants of Health - Outdoor concentrations of nitrogen dioxide (NO2)
Time Frame: Through study completion, an average of 18 years.
Data on ambient air quality will be obtained from the EPA DataMart for sites nearest each participant home address. Data will be obtained at the highest temporal resolution and averaged to daily and weekly values. Outdoor concentrations of NO2 will be measured in parts per billion (ppb).
Through study completion, an average of 18 years.
SPIROMICS III: Environmental and Social Determinants of Health - Outdoor concentrations of nitrogen oxides (NOx)
Time Frame: Through study completion, an average of 18 years.
Data on ambient air quality will be obtained from the EPA DataMart for sites nearest each participant home address. Data will be obtained at the highest temporal resolution and averaged to daily and weekly values. Outdoor concentrations of NOx will be measured in parts per billion (ppb).
Through study completion, an average of 18 years.
SPIROMICS III: Environmental and Social Determinants of Health - Outdoor concentrations of ozone (O3)
Time Frame: Through study completion, an average of 18 years.
Data on ambient air quality will be obtained from the EPA DataMart for sites nearest each participant home address. Data will be obtained at the highest temporal resolution and averaged to daily and weekly values. Outdoor concentrations of ozone will be measured in parts per billion (ppb).
Through study completion, an average of 18 years.
SPIROMICS III: Environmental and Social Determinants of Health - Outdoor concentrations of wildfire-derived particulate matter (PM) 2.5
Time Frame: Through study completion, an average of 18 years.
Data on ambient air quality will be obtained from the EPA DataMart for sites nearest each participant home address. Data will be obtained at the highest temporal resolution and averaged to daily and weekly values. Outdoor concentrations of wildfire-derived PM2.5 will be measured in micrograms per cubic meter of air (µg/m³).
Through study completion, an average of 18 years.
SPIROMICS III: Environmental and Social Determinants of Health - Indoor concentrations of particulate matter (PM)
Time Frame: Through study completion, an average of 18 years.
Indoor PM will be measured using a low-cost sensor monitor. Monitors will provide a year-long continuous in-home air monitoring and assessment. Indoor concentrations of PM2.5 will be measured in micrograms per cubic meter of air (µg/m³).
Through study completion, an average of 18 years.
SPIROMICS III: Environmental and Social Determinants of Health - Indoor measurements of temperature
Time Frame: Through study completion, an average of 18 years.
Indoor temperature will be measured using a low-cost sensor monitor. Monitors will provide a year-long continuous in-home air monitoring and assessment.
Through study completion, an average of 18 years.
SPIROMICS III: Environmental and Social Determinants of Health - Indoor measurements of humidity
Time Frame: Through study completion, an average of 18 years.
Indoor humidity will be measured using a low-cost sensor monitor. Monitors will provide a year-long continuous in-home air monitoring and assessment.
Through study completion, an average of 18 years.
SPIROMICS III: Environmental and Social Determinants of Health - Indoor measurements of NO2
Time Frame: Through study completion, an average of 18 years.
Airborne NO2 will be monitored with passive samplers for approximately one week or seven days in the home. Temperature and humidity measurements will be used to adjust the NO2 analytical results as appropriate. Indoor concentrations of NO2 will be measured in parts per billion (ppb).
Through study completion, an average of 18 years.
SPIROMICS III: Environmental and Social Determinants of Health - Indoor measurements of air nicotine
Time Frame: Through study completion, an average of 18 years.
Air nicotine will be monitored using passive sampling badges for one week or seven days in the home. Nicotine is collected by passive diffusion onto glass fiber filters treated with a 4% sodium bisulfate solution. The cassette is sealed and returned to the clinic laboratory for extraction and analysis. Indoor concentrations of airborne nicotine will be measured in micrograms per cubic meter (µg/m³).
Through study completion, an average of 18 years.
SPIROMICS III: Environmental and Social Determinants of Health - Indoor measurements of settled dust
Time Frame: Through study completion, an average of 18 years.
Settled dust samples will be collected from the home to ascertain exposure to common household allergens. The presence of indoor allergens will be assessed by extracting protein from the settled dust samples and quantifying them using enzyme-linked immunosorbent assay (ELISA).
Through study completion, an average of 18 years.
SPIROMICS III: Environmental and Social Determinants of Health - Geocoding
Time Frame: Through study completion, an average of 18 years.
Geocoding will assess residential mobility and neighborhood characteristics including area deprivation, food access, and segregation.
Through study completion, an average of 18 years.
SPIROMICS III: Epigenetic
Time Frame: Through study completion, an average of 18 years.
Illumina EPIC Methylation Arrays
Through study completion, an average of 18 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Repeatability Substudy: Repeatability of clinic visit measurements
Time Frame: Up to end of recruitment (2-6 week measurement repeatability)
The repeatability of clinic visit measurements will be assessed at the end of this substudy. In this substudy all clinic procedures and samples are repeated/recollected 2-6 weeks after the baseline clinic visit in a subset of participants. This provides a measurement of short-term repeatability of these assessments.
Up to end of recruitment (2-6 week measurement repeatability)
Exacerbation Substudy: Nasal swab analyses
Time Frame: Through study completion, an average of 18 years.
Self-administered nasal swabs will be collected during an acute exacerbation in a subset of participants. These will be used to better understand the biological processes underlying an acute exacerbation, including providing information about viral triggers and the host inflammatory response. Analyses will include measurements for RNA and DNA.
Through study completion, an average of 18 years.
Exacerbation Substudy: Sputum analyses for ribonucleic acid (RNA)
Time Frame: Through study completion, an average of 18 years.
Spontaneous sputum will be collected during an acute exacerbation in a subset of participants. It will be used to better understand the biological processes underlying an acute exacerbation, including initial characterization of the host response. Sputum will be analyzed for RNA and host gene expression.
Through study completion, an average of 18 years.
Exacerbation Substudy: Sputum analyses for mucins
Time Frame: Through study completion, an average of 18 years.
Spontaneous sputum will be collected during an acute exacerbation in a subset of participants. It will be used to better understand the biological processes underlying an acute exacerbation, including initial characterization of the host response. Sputum will be analyzed for mucins.
Through study completion, an average of 18 years.
Exacerbation Substudy: Sputum analyses for proteins
Time Frame: Through study completion, an average of 18 years.
Spontaneous sputum will be collected during an acute exacerbation in a subset of participants. It will be used to better understand the biological processes underlying an acute exacerbation, including initial characterization of the host response. Sputum will be analyzed for proteins.
Through study completion, an average of 18 years.
Exacerbation Substudy: Sputum analyses for cytokines
Time Frame: Through study completion, an average of 18 years.
Spontaneous sputum will be collected during an acute exacerbation in a subset of participants. It will be used to better understand the biological processes underlying an acute exacerbation, including initial characterization of the host response. Sputum will be analyzed for cytokines.
Through study completion, an average of 18 years.
Exacerbation Substudy: Assess symptomatic changes in COPD in relation to acute exacerbation
Time Frame: Through study completion, an average of 18 years.
The exacerbation substudy will collect a daily symptom diary. Data from this daily diary will be used to characterize the stable versus exacerbative state in a subset of participants.
Through study completion, an average of 18 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Neil Alexis, PhD, University of North Carolina, Chapel Hill
  • Principal Investigator: David Couper, PhD, University of North Carolina, Chapel Hill
  • Principal Investigator: Graham Barr, PhD, MD, Columbia University
  • Principal Investigator: Robert Paine, MD, University of Utah
  • Principal Investigator: Eric Hoffman, MD, University of Iowa
  • Study Chair: Prescott Woodruff, MD, University of California at San Francisco
  • Principal Investigator: Igor Barjaktarevic, MD, University of California at Los Angeles
  • Principal Investigator: MeiLan Han, MD, University of Michigan
  • Principal Investigator: Alejandro Cornellas, MD, University of Iowa
  • Principal Investigator: Nadia Hansel, MD, Johns Hopkins University
  • Principal Investigator: Jerry Krishnan, MD, University of Illinois at Chicago
  • Principal Investigator: Claudia Onofrei, MD, MSc, National Jewish Health
  • Principal Investigator: Nathaniel Marchetti, DO, Temple University
  • Principal Investigator: J. Michael Wells, MD, University of Alabama at Birmingham
  • Principal Investigator: Jessica Bon, MD, MS, ATSF, Wake Forest University
  • Principal Investigator: Robert Kaner, MD, Weill Medical College of Cornell University
  • Principal Investigator: Victor Ortega, MD, PhD, Mayo Clinic
  • Principal Investigator: Christopher Cooper, MD, PhD, University of California at Los Angeles
  • Principal Investigator: Sanjiv Shah, Northwestern University
  • Principal Investigator: Joao Lima, MD, MBA, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 Major Dates

Study Start

November 1, 2010

Primary Completion (Estimated)

June 17, 2031

Study Completion (Estimated)

June 17, 2031

Study Registration Dates

First Submitted

October 16, 2013

First Submitted That Met QC Criteria

October 21, 2013

First Posted (Estimated)

October 25, 2013

Study Record Updates

Last Update Posted (Estimated)

November 13, 2025

Last Update Submitted That Met QC Criteria

November 12, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 10-0048
  • R01HL144718 (U.S. NIH Grant/Contract)
  • HHSN268200900020C (Other Identifier: National Heart, Lung, and Blood Institute)
  • HHSN268200900013C (Other Identifier: National Heart, Lung, and Blood Institute)
  • HHSN268200900014C (Other Identifier: National Heart, Lung, and Blood Institute)
  • HHSN268200900015C (Other Identifier: National Heart, Lung, and Blood Institute)
  • HHSN268200900016C (Other Identifier: National Heart, Lung, and Blood Institute)
  • HHSN268200900017C (Other Identifier: National Heart, Lung, and Blood Institute)
  • HHSN268200900018C (Other Identifier: National Heart, Lung, and Blood Institute)
  • HHSN2682009000019C (Other Identifier: National Heart, Lung, and Blood Institute)
  • 5U01HL137880 (U.S. NIH Grant/Contract)
  • 1U24HL141762 (U.S. NIH Grant/Contract)
  • R01HL093081 (U.S. NIH Grant/Contract)
  • 75N92024D00012 (Other Identifier: National Heart, Lung, and Blood Institute)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data and biospecimens collected in SPIROMICS I were submitted to the NHLBI data and biospecimen repository known as BioLINCC. Data, including genetics and genomics, from SPIROMICS I and SPIROMICS II are submitted to the NIH data repository known as dbGaP. All data and biospecimens are also available through the SPIROMICS Genomics and Informatics Center (GIC) at the Collaborative Studies Coordinating Center (CSCC) at The University of North Carolina at Chapel Hill, by request, and according to study policies and procedures.

IPD Sharing Time Frame

Data and biospecimens from SPIROMICS I and SPIROMICS II are currently available and will remain available indefinitely. The same for data and biospecimens from SPIROMICS III on an annual basis.

IPD Sharing Access Criteria

Access criteria for data from BioLINCC are determined by NHLBI, not by the SPIROMICS Investigators.

Criteria, policies, and procedures for obtaining data and biospecimens directly from the SPIROMICS Genomics and Informatics Center (GIC) at the Collaborative Studies Coordinating Center (CSCC) at The University of North Carolina at Chapel Hill are available on the web site listed below.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Obstructive Pulmonary Disease

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