Subpopulations and Intermediate Markers in COPD Study (SPIROMICS)
Note that you will be prompted to log in or register an account
Accession Number
HLB01461719a
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
DLD
Dataset(s) Last Updated
June 28, 2019
Study Website
https://www.spiromics.com/spiromics/
Clinical Trial URLs
https://clinicaltrials.gov/ct2/show/NCT01969344
Primary Publication URLs
N/A
Consent
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).
Objectives
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.
Background
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.
Participants
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.
Design
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
There are 2,863 total subjects:
Non-smoker: 195
Smoker without COPD: 912
Mild/Moderate COPD: 1,159
Severe COPD: 597
| Non-smoker | Smoker without COPD | Mild/Moderate COPD | Severe COPD | Total Subjects |
---|---|---|---|---|---|
40-49 | 49 | 141 | 37 | 12 | 239 |
50-59 | 77 | 273 | 243 | 159 | 752 |
60-69 | 44 | 308 | 473 | 256 | 1,081 |
70-79 | 24 | 186 | 394 | 164 | 768 |
80-89 | 1 | 4 | 12 | 6 | 23 |
| Non-smoker | Smoker without COPD | Mild/Moderate COPD | Severe COPD | Total Subjects |
---|---|---|---|---|---|
Male | 74 | 435 | 679 | 328 | 1,516 |
Female | 121 | 477 | 480 | 269 | 1,347 |
| Non-smoker | Smoker without COPD | Mild/Moderate COPD | Severe COPD | Total Subjects |
---|---|---|---|---|---|
White | 136 | 622 | 959 | 473 | 2,190 |
Black | 43 | 240 | 159 | 102 | 544 |
Asian | 4 | 6 | 13 | 6 | 29 |
Amer.Ind./Pacif.Isl. | 3 | 4 | 6 | 2 | 15 |
Mixed | 7 | 35 | 16 | 11 | 69 |
Missing | 2 | 5 | 6 | 3 | 16 |
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
Serum, Plasma, Urine, Sputum, Bronchial Lavage, Bronchial Wash, Oral Wash
As of 02/08/2024, nearly all specimens are unthawed. Very few plasma and BAL specimens have undergone at least 1 freeze-thaw cycle.
02/08/2024
| Serum | Plasma | Bronchial wash | Urine | Bronchoalveolar Lavage (BAL) | Oral Wash (Saline) | Sputum | Total Vials |
---|---|---|---|---|---|---|---|---|
Baseline | 17,213 | 37,886 | . | 13,556 | . | . | 1,813 | 70,468 |
Bronchoscopy | . | . | 191 | . | 1,130 | 154 | . | 1,475 |
Year 1 | 15,215 | 31,812 | . | 10,899 | . | . | . | 57,926 |
Year 3 | 5,914 | 12,168 | . | 4,727 | . | . | . | 22,809 |
02/08/2024
| Serum | |
---|---|---|
Total number of subjects | Average volume (mL) per subject | |
Baseline | 2,702 | 1.63 |
Year 1 | 2,129 | 1.78 |
Year 3 | 819 | 1.77 |
| Plasma | |
---|---|---|
Total number of subjects | Average volume (mL) per subject | |
Baseline | 2,709 | 4.52 |
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 |
| Urine | |
---|---|---|
Total number of subjects | Average volume (mL) per subject | |
Baseline | 2,655 | 5.11 |
Year 1 | 2,078 | 5.25 |
Year 3 | 787 | 6.00 |
| Bronchoalveolar Lavage (BAL) | |
---|---|---|
Total number of subjects | Average volume (mL) per subject | |
Bronchoscopy | 155 | 5.07 |
| Oral Wash (Saline) | |
---|---|---|
Total number of subjects | Average volume (mL) per subject | |
Bronchoscopy | 154 | 10.01 |
| Sputum | |
---|---|---|
Total number of subjects | Average volume (mL) per subject | |
Baseline | 889 | 2.14 |
Please note that researchers must be registered on this site to submit a request, and you will be prompted to log in. If you are not registered on this site, you can do so via the Request button. Registration is quick, easy and free.
Resources Available
Specimens and Study DatasetsMaterials Available
- Bronchial Lavage
- Bronchial Wash
- Oral Wash (Saline)
- Plasma
- Serum
- Sputum
- Urine
- More Details
Study Documents
- Data Dictionary (PDF - 62.8 MB)
- Forms (PDF - 9.5 MB)
- Protocol (PDF - 901.7 KB)
- Protocol Synopsis (PDF - 323.5 KB)
- Procedure Manuals
Persons using assistive technology may not be able to fully access information in the study documents. For assistance, Contact BioLINCC and include the web address and/or publication title in your message. If you need help accessing information in different file formats such as PDF, XLS, DOC, see Instructions for Downloading Viewers and Players.