Subpopulations and Intermediate Markers in COPD Study (SPIROMICS)

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Accession Number

Study Type
Epidemiology Study

Collection Type
Open BioLINCC Study See bottom of this webpage for request information

Study Period
November 2010 – July 2018

NHLBI Division

Dataset(s) Last Updated
June 28, 2019

Primary Publication URLs


Commercial Use Data Restrictions Yes

Data Restrictions Based On Area Of Research Yes

Commercial Use Specimen Restrictions Yes

Non-Genetic Use Specimen Restrictions Based On Area Of Use Yes

Genetic Use Of Specimens Allowed? Yes, For Some Specimens

Genetic Use Area Of Research Restrictions Yes

Specific Consent Restrictions
Use of data and/or biospecimens in is tiered to (1) COPD research only, or (2) other types of research. Study participants were also given the option to consent to commercial use of specimens and/or data, as well as to use of specimens in genetic research.

Available Data

Data available for request include SPIROMICS I main study data as well as SPIROMICS Bridge phone call follow-up period data (period between SPIROMICS I NIH contract and SPIROMICS II grant).


The SPIROMICS study sought to identify homogeneous subgroups of COPD patients for targeted enrollment in future therapeutic clinical trials, as well as to identify and conduct preliminary validation of intermediate biological or clinical outcomes for use as clinical trial endpoints.


Chronic obstructive pulmonary disease (COPD) is a chronic, usually progressive, lung disease characterized by incompletely reversible airflow obstruction. At the time of the SPIROMICS study, COPD affected between 12,000,000 and 24,000,000 people in the US, with no proven medical therapies that significantly reduce mortality, other than supplemental oxygen and smoking cessation. COPD is also a highly heterogeneous disease. For example, cigarette smoke-induced chronic bronchitis and emphysema are subsumed within the COPD definition, despite histological and clinical differences. The recognition of COPD as a systemic disease that affects extra-pulmonary systems, including cardiovascular, sleep and muscle function, further complicates disease classification. Because of clinical and pathological heterogeneity, individual patient subtypes may benefit from unique therapeutic regimens. Thus the SPIROMICS study was initiated to facilitate the identification of important COPD phenotypes, based on disease pathophysiology and biomarkers that track key pathophysiologic processes, in order to focus research efforts and improve treatment options.


Eligible participants were between 40 and 80 years of age, and included never-smokers, current and former smokers without obstructive lung disease, and current and former smokers with COPD. Never smoker was defined as less than 1 pack-year smoking history, and current or former smoker were defined as more than 20 pack-years smoking history. Lung function was also part of the eligibility criteria and was assessed by spirometry with or without inhaled bronchodilators. Non-smokers were required to have pre-bronchodilator FEV1 (forced expiratory volume in one second)/FVC (forced vital capacity) > 0.7 and FVC > LLN (lower limit of normal). Current or former smokers without obstructive lung disease were required to have post-bronchodilator FEV1/FVC > 0.7 and FVC > LLN. Current or former smokers with obstructive lung disease were required to have post-bronchodilator FEV1/FVC < 0.7 and FEV1 > 50% predicted.

Major exclusion criteria included non-COPD obstructive lung disease or a history of diseases or treatments likely to interfere with interpretation of study tests, BMI > 40 kg/m2 at baseline, hypersensitivity to or intolerance of the bronchodilators used in study assessments, and diagnosis of unstable cardiovascular disease.


SPIROMICS was a prospective cohort study that enrolled approximately 2,981 participants at twelve clinical centers over five years. Participants were distributed across four enrollment strata; never-smokers, smokers without COPD, smokers with mild or moderate COPD, and smokers with severe COPD.

There were baseline (Visit 1) and three annual in-person follow-up visits (Visits 2–4). Participants also received quarterly follow-up calls to assess health status and determine if an exacerbation occurred. Visits 1, 2 and 4, included anthropometry, seated blood pressure, spirometry, 6-minute walk test, biological specimen collection, and a series of questionnaires. Information was collected on medical history, respiratory exposures and current medications. Visits 1 and 2 included a thoracic computed tomography (CT) scan at maximum inspiration and expiration.

Clinical outcomes, including hospitalizations and deaths, were adjudicated centrally. The primary outcome measures up to month 36 were (1) morbidity measured by assessing acute exacerbations, (2) lung function by using spirometry and plethysmography to measure FEV1, FVC, FRC (functional residual capacity), and IC (inspiratory capacity), and (3) mortality.

There were several key sub-studies involving SPIROMICS participants. The Repeatability and Replicate Sub-study enrolled 98 participants and repeated the entire baseline clinic visit, including the CT scanning, in order to quantify reliability and short-term within-person variability of study procedures and assay methods. In addition, sites collected blinded replicate samples on 5% of each specimen type at the Baseline, Year 1, and Year 3 visits. The Bronchoscopy Sub-study enrolled a total of 250 subjects to undergo bronchoscopy with bronchoalveolar lavage, epithelial brushings and bronchial biopsies. The Exacerbation Sub-study enrolled a total of 214 participants that were followed prospectively and had biological samples (not available via BioLINCC) and clinical information collected at the time of an acute exacerbation.

David Couper et al. Design of the subpopulations and intermediate outcomes in COPD study (SPIROMICS). Thorax. 2014;69(5):492–495.

Additional Details

  Frequency Percent Cumulative
Non-smoker 194 6.74 194 6.74
Smoker without COPD 917 31.87 1111 38.62
Mild/Moderate COPD 1168 40.60 2279 79.21
Severe COPD 598 20.79 2877 100.00
  Frequency Percent Cumulative
40-<45 86 2.99 86 2.99
45-<50 154 5.35 240 8.34
50-<55 332 11.54 572 19.88
55-<60 423 14.70 995 34.58
60-<65 443 15.40 1438 49.98
65-<70 644 22.38 2082 72.37
70-<75 522 18.14 2604 90.51
75-80 273 9.49 2877 100.00
  Frequency Percent Cumulative
Male 1520 52.83 1520 52.83
Female 1357 47.17 2877 100.00
  Frequency Percent Cumulative
White 2202 76.54 2202 76.54
Black 545 18.94 2747 95.48
Asian 29 1.01 2776 96.49
Amer.Ind. or Pacif.Isl. 15 0.52 2791 97.01
Mixed 69 2.40 2860 99.41
Missing 17 0.59 2877 100.00
  Frequency Percent Cumulative
Missing 1 0.03 1 0.03
Non-hispanic 2729 94.86 2730 94.89
Hispanic 147 5.11 2877 100.00

Please note that biospecimen availability is subject to review by the NHLBI, BioLINCC, and the NHLBI Biorepository. Certain biospecimens may not be made available for your request. Section 3 of the BioLINCC handbook describes the components of the review process

Material Types:

Serum, Plasma, Urine, Sputum, Bronchial Lavage, Bronchial Wash, Oral Wash

General Freeze/Thaw Status:

All samples have never been thawed

Visits (Vials):
  Baseline Baseline Repeatability Bronchoscopy Year 1 Year 3 Total
Serum 16620 593 0 15215 5914 38342
Plasma 36632 1254 0 31812 12168 81866
Bronchial Wash 0 0 191 0 0 191
Urine 13092 464 0 10899 4727 29182
BAL 0 0 1151 0 0 1151
Oral Wash 0 0 154 0 0 154
Sputum 1758 55 0 0 0 1813

Visits (Subjects):
Total number of subjects Average volume (mL) per subject
Baseline 2,700 1.58
Baseline Repeatability 89 1.74
Year 1 2,129 1.78
Year 3 819 1.77
Total number of subjects Average volume (mL) per subject
Baseline 2,707 4.37
Baseline Repeatability 89 4.69
Year 1 2,128 4.65
Year 3 818 4.52
  Bronchial Wash
Total number of subjects Average volume (mL) per subject
Bronchoscopy 40 2.48
Total number of subjects Average volume (mL) per subject
Baseline 2,653 4.94
Baseline Repeatability 89 5.21
Year 1 2,078 5.25
Year 3 787 6.00
Total number of subjects Average volume (mL) per subject
Bronchoscopy 155 5.66
  Oral Wash
Total number of subjects Average volume (mL) per subject
Bronchoscopy 154 10.01
Total number of subjects Average volume (mL) per subject
Baseline 882 2.09
Baseline Repeatability 28 2.22

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Resources Available

Specimens and Study Datasets

Materials Available

  • Bronchial Lavage
  • Bronchial Wash
  • Oral Wash (Saline)
  • Plasma
  • Serum
  • Sputum
  • Urine
  • More Details

Study Documents

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