COPDSPIROMICSNCT01969344

Study of COPD Subgroups and Biomarkers

An observational study of COPD and Chronic Obstructive Pulmonary Disease, run by University of North Carolina, Chapel Hill at 14 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

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… Read more about this study

Who is it for?: Ages 40 to 80 yearsHealthy volunteers can take part
Conditions the study is for: COPD, Chronic Obstructive Pulmonary Disease, Chronic Bronchitis
How many people: 2,981 participants
Where: 14 sitesUnited States
Study dates: Nov 2010to 17 Jun 2031
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 40 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Show all 36Show fewer

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.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

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

Other trials in United States

About this study

Official title: 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.

Read the 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:

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.
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.
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:

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.
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.

Conditions: COPD, Chronic Obstructive Pulmonary Disease, Chronic Bronchitis, Emphysema
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic, Emphysema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01969344
Study group	Role	What they receive
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 being measured

The primary outcome is the main question the study is designed to answer.

Morbidity
Morbidity in SPIROMICS will primarily be measured by assessing acute exacerbations in the SPIROMICS cohort.
Measured: Through study completion, an average of 18 years.
Lung Function
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.
Measured: Through study completion, an average of 18 years.
Mortality
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.
Measured: Through study completion, an average of 18 years.
SPIROMICS III: Radiology - Emphysema Volume
Percent Emphysema (percent <-950HU)
Measured: Through study completion, an average of 18 years.
SPIROMICS III: Radiology - Functional Small Airway Disease through Parametric Response Mapping (PRM)
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.
Measured: Through study completion, an average of 18 years.
SPIROMICS III: Radiology - Functional Small Airway Disease through Disease Probability Method (DPM)
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.
Measured: Through study completion, an average of 18 years.
SPIROMICS III: Radiology - Airway Wall Thickness
Pi10 as a measure of airway wall thickness
Measured: Through study completion, an average of 18 years.
SPIROMICS III: Physiology - Lung function (Spirometry)
Lung function will be assessed as FEV1 through spirometry using forced and slow vital capacity before and after bronchodilator (BD) administration.
Measured: Through study completion, an average of 18 years.
SPIROMICS III: Physiology - Lung function (Respiratory Oscillometry)
Assessment of lung function through respiratory oscillometry.
Measured: Through study completion, an average of 18 years.
SPIROMICS III: Biological - Mucin concentrations
Mucus samples obtained from sputum, bronchial brushings, and Bronchoalveolar Lavage (BAL) will be analyzed for total mucin concentration.
Measured: Through study completion, an average of 18 years.
SPIROMICS III: Biological - MUCQ index
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.
Measured: Through study completion, an average of 18 years.
SPIROMICS III: Biological - Mucin-interacting proteins
Mucin-interacting proteins will be identified and quantified using labeled and label free mass spectrometry.
Measured: Through study completion, an average of 18 years.
SPIROMICS III: Environmental and Social Determinants of Health - Outdoor concentrations of particulate matter (PM) 2.5
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).
Measured: Through study completion, an average of 18 years.
SPIROMICS III: Environmental and Social Determinants of Health - Outdoor concentrations of nitrogen dioxide (NO2)
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).
Measured: Through study completion, an average of 18 years.
SPIROMICS III: Environmental and Social Determinants of Health - Outdoor concentrations of nitrogen oxides (NOx)
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).
Measured: Through study completion, an average of 18 years.
SPIROMICS III: Environmental and Social Determinants of Health - Outdoor concentrations of ozone (O3)
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).
Measured: 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
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).
Measured: Through study completion, an average of 18 years.
SPIROMICS III: Environmental and Social Determinants of Health - Indoor concentrations of particulate matter (PM)
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).
Measured: Through study completion, an average of 18 years.
SPIROMICS III: Environmental and Social Determinants of Health - Indoor measurements of temperature
Indoor temperature will be measured using a low-cost sensor monitor. Monitors will provide a year-long continuous in-home air monitoring and assessment.
Measured: Through study completion, an average of 18 years.
SPIROMICS III: Environmental and Social Determinants of Health - Indoor measurements of humidity
Indoor humidity will be measured using a low-cost sensor monitor. Monitors will provide a year-long continuous in-home air monitoring and assessment.
Measured: Through study completion, an average of 18 years.
SPIROMICS III: Environmental and Social Determinants of Health - Indoor measurements of NO2
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).
Measured: Through study completion, an average of 18 years.
SPIROMICS III: Environmental and Social Determinants of Health - Indoor measurements of air nicotine
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).
Measured: Through study completion, an average of 18 years.
SPIROMICS III: Environmental and Social Determinants of Health - Indoor measurements of settled dust
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).
Measured: Through study completion, an average of 18 years.
SPIROMICS III: Environmental and Social Determinants of Health - Geocoding
Geocoding will assess residential mobility and neighborhood characteristics including area deprivation, food access, and segregation.
Measured: Through study completion, an average of 18 years.
SPIROMICS III: Epigenetic
Illumina EPIC Methylation Arrays
Measured: Through study completion, an average of 18 years.

Secondary outcomes (7)

Repeatability Substudy: Repeatability of clinic visit measurements
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.
Measured: Up to end of recruitment (2-6 week measurement repeatability)
Exacerbation Substudy: Nasal swab analyses
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.
Measured: Through study completion, an average of 18 years.
Exacerbation Substudy: Sputum analyses for ribonucleic acid (RNA)
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.
Measured: Through study completion, an average of 18 years.
Exacerbation Substudy: Sputum analyses for mucins
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.
Measured: Through study completion, an average of 18 years.
Exacerbation Substudy: Sputum analyses for proteins
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.
Measured: Through study completion, an average of 18 years.
Exacerbation Substudy: Sputum analyses for cytokines
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.
Measured: Through study completion, an average of 18 years.
Exacerbation Substudy: Assess symptomatic changes in COPD in relation to acute exacerbation
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.
Measured: Through study completion, an average of 18 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 201017 Jun 2031

First posted25 Oct 2013 (estimated)
Study startNov 2010
Primary completion17 Jun 2031 (estimated)
Study completion17 Jun 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (125)Papers the sponsor has linked to this study.
Other trials for COPDStudies of the same condition, open and under way.
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: Prospective
Enrolment: 2,981 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01969344
Sponsor's protocol ID: 10-0048
Other IDs: 5U01HL137880, 1U24HL141762, R01HL144718, R01HL093081, HHSN268200900020C, HHSN268200900013C, HHSN268200900014C, HHSN268200900015C
Acronym: SPIROMICS
Status last verified: Sep 2025
First submitted: 16 Oct 2013
Last updated: 13 Nov 2025
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Yes: 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.

Publications

Couper D, LaVange LM, Han M, Barr RG, Bleecker E, Hoffman EA, Kanner R, Kleerup E, Martinez FJ, Woodruff PG, Rennard S; SPIROMICS Research Group. Design of the Subpopulations and Intermediate Outcomes in COPD Study (SPIROMICS). Thorax. 2014 May;69(5):491-4. doi: 10.1136/thoraxjnl-2013-203897. Epub 2013 Sep 12.
PubMed 24029743
Freeman CM, Crudgington S, Stolberg VR, Brown JP, Sonstein J, Alexis NE, Doerschuk CM, Basta PV, Carretta EE, Couper DJ, Hastie AT, Kaner RJ, O'Neal WK, Paine R 3rd, Rennard SI, Shimbo D, Woodruff PG, Zeidler M, Curtis JL. Design of a multi-center immunophenotyping analysis of peripheral blood, sputum and bronchoalveolar lavage fluid in the Subpopulations and Intermediate Outcome Measures in COPD Study (SPIROMICS). J Transl Med. 2015 Jan 27;13:19. doi: 10.1186/s12967-014-0374-z.
PubMed 25622723
Sieren JP, Newell JD Jr, Barr RG, Bleecker ER, Burnette N, Carretta EE, Couper D, Goldin J, Guo J, Han MK, Hansel NN, Kanner RE, Kazerooni EA, Martinez FJ, Rennard S, Woodruff PG, Hoffman EA; SPIROMICS Research Group. SPIROMICS Protocol for Multicenter Quantitative Computed Tomography to Phenotype the Lungs. Am J Respir Crit Care Med. 2016 Oct 1;194(7):794-806. doi: 10.1164/rccm.201506-1208PP.
PubMed 27482984
Hansel NN, Paulin LM, Gassett AJ, Peng RD, Alexis N, Fan VS, Bleecker E, Bowler R, Comellas AP, Dransfield M, Han MK, Kim V, Krishnan JA, Pirozzi C, Cooper CB, Martinez F, Woodruff PG, Breysse PJ, Barr RG, Kaufman JD. Design of the Subpopulations and Intermediate Outcome Measures in COPD (SPIROMICS) AIR Study. BMJ Open Respir Res. 2017 May 18;4(1):e000186. doi: 10.1136/bmjresp-2017-000186. eCollection 2017.
PubMed 28948026
O'Neal WK, Anderson W, Basta PV, Carretta EE, Doerschuk CM, Barr RG, Bleecker ER, Christenson SA, Curtis JL, Han MK, Hansel NN, Kanner RE, Kleerup EC, Martinez FJ, Miller BE, Peters SP, Rennard SI, Scholand MB, Tal-Singer R, Woodruff PG, Couper DJ, Davis SM; SPIROMICS Investigators. Comparison of serum, EDTA plasma and P100 plasma for luminex-based biomarker multiplex assays in patients with chronic obstructive pulmonary disease in the SPIROMICS study. J Transl Med. 2014 Jan 8;12:9. doi: 10.1186/1479-5876-12-9.
PubMed 24397870
Smith BM, Hoffman EA, Rabinowitz D, Bleecker E, Christenson S, Couper D, Donohue KM, Han MK, Hansel NN, Kanner RE, Kleerup E, Rennard S, Barr RG. Comparison of spatially matched airways reveals thinner airway walls in COPD. The Multi-Ethnic Study of Atherosclerosis (MESA) COPD Study and the Subpopulations and Intermediate Outcomes in COPD Study (SPIROMICS). Thorax. 2014 Nov;69(11):987-96. doi: 10.1136/thoraxjnl-2014-205160. Epub 2014 Jun 13.
PubMed 24928812
Boes JL, Hoff BA, Bule M, Johnson TD, Rehemtulla A, Chamberlain R, Hoffman EA, Kazerooni EA, Martinez FJ, Han MK, Ross BD, Galban CJ. Parametric response mapping monitors temporal changes on lung CT scans in the subpopulations and intermediate outcome measures in COPD Study (SPIROMICS). Acad Radiol. 2015 Feb;22(2):186-94. doi: 10.1016/j.acra.2014.08.015. Epub 2014 Nov 4.
PubMed 25442794
Putcha N, Puhan MA, Drummond MB, Han MK, Regan EA, Hanania NA, Martinez CH, Foreman M, Bhatt SP, Make B, Ramsdell J, DeMeo DL, Barr RG, Rennard SI, Martinez F, Silverman EK, Crapo J, Wise RA, Hansel NN. A simplified score to quantify comorbidity in COPD. PLoS One. 2014 Dec 16;9(12):e114438. doi: 10.1371/journal.pone.0114438. eCollection 2014.
PubMed 25514500
Paulin LM, Diette GB, Blanc PD, Putcha N, Eisner MD, Kanner RE, Belli AJ, Christenson S, Tashkin DP, Han M, Barr RG, Hansel NN; SPIROMICS Research Group. Occupational exposures are associated with worse morbidity in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2015 Mar 1;191(5):557-65. doi: 10.1164/rccm.201408-1407OC.
PubMed 25562375
Martinez CH, Diaz AA, Parulekar AD, Rennard SI, Kanner RE, Hansel NN, Couper D, Holm KE, Hoth KF, Curtis JL, Martinez FJ, Hanania NA, Regan EA, Paine R 3rd, Cigolle CT, Han MK; COPDGene and SPIROMICS Investigators. Age-Related Differences in Health-Related Quality of Life in COPD: An Analysis of the COPDGene and SPIROMICS Cohorts. Chest. 2016 Apr;149(4):927-35. doi: 10.1016/j.chest.2015.11.025. Epub 2015 Dec 17.
PubMed 26836895
Putcha N, Barr RG, Han MK, Woodruff PG, Bleecker ER, Kanner RE, Martinez FJ, Smith BM, Tashkin DP, Bowler RP, Eisner MD, Rennard SI, Wise RA, Hansel NN; SPIROMICS Investigators. Understanding the impact of second-hand smoke exposure on clinical outcomes in participants with COPD in the SPIROMICS cohort. Thorax. 2016;71:411-420. doi: 10.1136/thoraxjnl-2015-207487. Epub 2016 Mar 9.
PubMed 26962015
Guo J, Wang C, Chan KS, Jin D, Saha PK, Sieren JP, Barr RG, Han MK, Kazerooni E, Cooper CB, Couper D, Newell JD Jr, Hoffman EA; SPIROMICS Research Group. A controlled statistical study to assess measurement variability as a function of test object position and configuration for automated surveillance in a multicenter longitudinal COPD study (SPIROMICS). Med Phys. 2016 May;43(5):2598. doi: 10.1118/1.4947303.
PubMed 27147369
Woodruff PG, Barr RG, Bleecker E, Christenson SA, Couper D, Curtis JL, Gouskova NA, Hansel NN, Hoffman EA, Kanner RE, Kleerup E, Lazarus SC, Martinez FJ, Paine R 3rd, Rennard S, Tashkin DP, Han MK; SPIROMICS Research Group. Clinical Significance of Symptoms in Smokers with Preserved Pulmonary Function. N Engl J Med. 2016 May 12;374(19):1811-21. doi: 10.1056/NEJMoa1505971.
PubMed 27168432
Sun W, Kechris K, Jacobson S, Drummond MB, Hawkins GA, Yang J, Chen TH, Quibrera PM, Anderson W, Barr RG, Basta PV, Bleecker ER, Beaty T, Casaburi R, Castaldi P, Cho MH, Comellas A, Crapo JD, Criner G, Demeo D, Christenson SA, Couper DJ, Curtis JL, Doerschuk CM, Freeman CM, Gouskova NA, Han MK, Hanania NA, Hansel NN, Hersh CP, Hoffman EA, Kaner RJ, Kanner RE, Kleerup EC, Lutz S, Martinez FJ, Meyers DA, Peters SP, Regan EA, Rennard SI, Scholand MB, Silverman EK, Woodruff PG, O'Neal WK, Bowler RP; SPIROMICS Research Group; COPDGene Investigators. Common Genetic Polymorphisms Influence Blood Biomarker Measurements in COPD. PLoS Genet. 2016 Aug 17;12(8):e1006011. doi: 10.1371/journal.pgen.1006011. eCollection 2016 Aug.
PubMed 27532455
Martinez CH, Diaz AA, Meldrum C, Curtis JL, Cooper CB, Pirozzi C, Kanner RE, Paine R 3rd, Woodruff PG, Bleecker ER, Hansel NN, Barr RG, Marchetti N, Criner GJ, Kazerooni EA, Hoffman EA, Ross BD, Galban CJ, Cigolle CT, Martinez FJ, Han MK; SPIROMICS Investigators. Age and Small Airway Imaging Abnormalities in Subjects with and without Airflow Obstruction in SPIROMICS. Am J Respir Crit Care Med. 2017 Feb 15;195(4):464-472. doi: 10.1164/rccm.201604-0871OC.
PubMed 27564413

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
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 recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia

All COPD trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Subpopulations and Intermediate Outcome Measures in COPD Study
ClinicalTrials.gov ID: NCT01969344
Acronym / sponsor ID: SPIROMICS / 10-0048
Conditions: COPD, Chronic Obstructive Pulmonary Disease, Chronic Bronchitis, Emphysema
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 2,981 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), COPD Foundation, Columbia University, Johns Hopkins University, National Jewish Health, Temple University, University of Alabama at Birmingham, University of California, Los Angeles, University of California, San Francisco, University of Illinois at Chicago, University of Iowa, University of Michigan, University of Utah, Wake Forest University
Study start: Nov 2010
Primary completion: 17 Jun 2031 (estimated)
Study completion: 17 Jun 2031 (estimated)
First posted: 25 Oct 2013 (estimated)
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.

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

Detailed description

Description of SPIROMICS I:

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

Sub studies:

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.
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.
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:

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.
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:

Description of SPIROMICS III:

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 4

Arm	Type	Receives
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).

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (5 listed)

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

Key exclusion criteria (36 listed)

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

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

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.
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.
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.
SPIROMICS III: Radiology - Emphysema Volume
Time frame: Through study completion, an average of 18 years.
Percent Emphysema (percent <-950HU)
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.
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.
SPIROMICS III: Radiology - Airway Wall Thickness
Time frame: Through study completion, an average of 18 years.
Pi10 as a measure of airway wall thickness
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.
SPIROMICS III: Physiology - Lung function (Respiratory Oscillometry)
Time frame: Through study completion, an average of 18 years.
Assessment of lung function through respiratory oscillometry.
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.
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.
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.
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).
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).
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).
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).
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).
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).
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.
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.
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).
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).
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).
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.
SPIROMICS III: Epigenetic
Time frame: Through study completion, an average of 18 years.
Illumina EPIC Methylation Arrays

7 secondary outcomes

Repeatability Substudy: Repeatability of clinic visit measurements
Time frame: 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.
Exacerbation Substudy: Sputum analyses for ribonucleic acid (RNA)
Time frame: Through study completion, an average of 18 years.
Exacerbation Substudy: Sputum analyses for mucins
Time frame: Through study completion, an average of 18 years.
Exacerbation Substudy: Sputum analyses for proteins
Time frame: Through study completion, an average of 18 years.
Exacerbation Substudy: Sputum analyses for cytokines
Time frame: 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.

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 13 Nov 2025.
Background: PubMed 24029743Couper D, LaVange LM, Han M, Barr RG, Bleecker E, Hoffman EA, Kanner R, Kleerup E, Martinez FJ, Woodruff PG, Rennard S; SPIROMICS Research Group. Design of the Subpopulations and Intermediate Outcomes in COPD Study (SPIROMICS). Thorax. 2014 May;69(5):491-4. doi: 10.1136/thoraxjnl-2013-203897. Epub 2013 Sep 12.
Background: PubMed 25622723Freeman CM, Crudgington S, Stolberg VR, Brown JP, Sonstein J, Alexis NE, Doerschuk CM, Basta PV, Carretta EE, Couper DJ, Hastie AT, Kaner RJ, O'Neal WK, Paine R 3rd, Rennard SI, Shimbo D, Woodruff PG, Zeidler M, Curtis JL. Design of a multi-center immunophenotyping analysis of peripheral blood, sputum and bronchoalveolar lavage fluid in the Subpopulations and Intermediate Outcome Measures in COPD Study (SPIROMICS). J Transl Med. 2015 Jan 27;13:19. doi: 10.1186/s12967-014-0374-z.
Background: PubMed 27482984Sieren JP, Newell JD Jr, Barr RG, Bleecker ER, Burnette N, Carretta EE, Couper D, Goldin J, Guo J, Han MK, Hansel NN, Kanner RE, Kazerooni EA, Martinez FJ, Rennard S, Woodruff PG, Hoffman EA; SPIROMICS Research Group. SPIROMICS Protocol for Multicenter Quantitative Computed Tomography to Phenotype the Lungs. Am J Respir Crit Care Med. 2016 Oct 1;194(7):794-806. doi: 10.1164/rccm.201506-1208PP.
Background: PubMed 28948026Hansel NN, Paulin LM, Gassett AJ, Peng RD, Alexis N, Fan VS, Bleecker E, Bowler R, Comellas AP, Dransfield M, Han MK, Kim V, Krishnan JA, Pirozzi C, Cooper CB, Martinez F, Woodruff PG, Breysse PJ, Barr RG, Kaufman JD. Design of the Subpopulations and Intermediate Outcome Measures in COPD (SPIROMICS) AIR Study. BMJ Open Respir Res. 2017 May 18;4(1):e000186. doi: 10.1136/bmjresp-2017-000186. eCollection 2017.
Results publication: PubMed 24397870O'Neal WK, Anderson W, Basta PV, Carretta EE, Doerschuk CM, Barr RG, Bleecker ER, Christenson SA, Curtis JL, Han MK, Hansel NN, Kanner RE, Kleerup EC, Martinez FJ, Miller BE, Peters SP, Rennard SI, Scholand MB, Tal-Singer R, Woodruff PG, Couper DJ, Davis SM; SPIROMICS Investigators. Comparison of serum, EDTA plasma and P100 plasma for luminex-based biomarker multiplex assays in patients with chronic obstructive pulmonary disease in the SPIROMICS study. J Transl Med. 2014 Jan 8;12:9. doi: 10.1186/1479-5876-12-9.
Results publication: PubMed 24928812Smith BM, Hoffman EA, Rabinowitz D, Bleecker E, Christenson S, Couper D, Donohue KM, Han MK, Hansel NN, Kanner RE, Kleerup E, Rennard S, Barr RG. Comparison of spatially matched airways reveals thinner airway walls in COPD. The Multi-Ethnic Study of Atherosclerosis (MESA) COPD Study and the Subpopulations and Intermediate Outcomes in COPD Study (SPIROMICS). Thorax. 2014 Nov;69(11):987-96. doi: 10.1136/thoraxjnl-2014-205160. Epub 2014 Jun 13.
Results publication: PubMed 25442794Boes JL, Hoff BA, Bule M, Johnson TD, Rehemtulla A, Chamberlain R, Hoffman EA, Kazerooni EA, Martinez FJ, Han MK, Ross BD, Galban CJ. Parametric response mapping monitors temporal changes on lung CT scans in the subpopulations and intermediate outcome measures in COPD Study (SPIROMICS). Acad Radiol. 2015 Feb;22(2):186-94. doi: 10.1016/j.acra.2014.08.015. Epub 2014 Nov 4.
Results publication: PubMed 25514500Putcha N, Puhan MA, Drummond MB, Han MK, Regan EA, Hanania NA, Martinez CH, Foreman M, Bhatt SP, Make B, Ramsdell J, DeMeo DL, Barr RG, Rennard SI, Martinez F, Silverman EK, Crapo J, Wise RA, Hansel NN. A simplified score to quantify comorbidity in COPD. PLoS One. 2014 Dec 16;9(12):e114438. doi: 10.1371/journal.pone.0114438. eCollection 2014.
Results publication: PubMed 25562375Paulin LM, Diette GB, Blanc PD, Putcha N, Eisner MD, Kanner RE, Belli AJ, Christenson S, Tashkin DP, Han M, Barr RG, Hansel NN; SPIROMICS Research Group. Occupational exposures are associated with worse morbidity in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2015 Mar 1;191(5):557-65. doi: 10.1164/rccm.201408-1407OC.
Results publication: PubMed 26836895Martinez CH, Diaz AA, Parulekar AD, Rennard SI, Kanner RE, Hansel NN, Couper D, Holm KE, Hoth KF, Curtis JL, Martinez FJ, Hanania NA, Regan EA, Paine R 3rd, Cigolle CT, Han MK; COPDGene and SPIROMICS Investigators. Age-Related Differences in Health-Related Quality of Life in COPD: An Analysis of the COPDGene and SPIROMICS Cohorts. Chest. 2016 Apr;149(4):927-35. doi: 10.1016/j.chest.2015.11.025. Epub 2015 Dec 17.
Results publication: PubMed 26962015Putcha N, Barr RG, Han MK, Woodruff PG, Bleecker ER, Kanner RE, Martinez FJ, Smith BM, Tashkin DP, Bowler RP, Eisner MD, Rennard SI, Wise RA, Hansel NN; SPIROMICS Investigators. Understanding the impact of second-hand smoke exposure on clinical outcomes in participants with COPD in the SPIROMICS cohort. Thorax. 2016;71:411-420. doi: 10.1136/thoraxjnl-2015-207487. Epub 2016 Mar 9.
Results publication: PubMed 27147369Guo J, Wang C, Chan KS, Jin D, Saha PK, Sieren JP, Barr RG, Han MK, Kazerooni E, Cooper CB, Couper D, Newell JD Jr, Hoffman EA; SPIROMICS Research Group. A controlled statistical study to assess measurement variability as a function of test object position and configuration for automated surveillance in a multicenter longitudinal COPD study (SPIROMICS). Med Phys. 2016 May;43(5):2598. doi: 10.1118/1.4947303.
Study WebsiteLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

Related trials for COPD

Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
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 recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia

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. This study is not recruiting at the moment.

David Couper, PhD principal investigator

University of North Carolina, Chapel Hill

Graham Barr, PhD, MD principal investigator

Columbia University

Robert Paine, MD principal investigator

University of Utah

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of COPD and Chronic Obstructive Pulmonary Disease, run by University of North Carolina, Chapel Hill at 14 sites 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 5 inclusion and 36 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: under way, not looking for participants, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites 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?

Morbidity (time frame: Through study completion, an average of 18 years.). The study lists 25 primary outcomes in all. 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 NCT01969344, which also lists 125 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 13 Nov 2025.