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Home > Studies > Subpopulations and Intermediate Markers in COPD Study (SPIROMICS)

Subpopulations and Intermediate Markers in COPD Study (SPIROMICS)

Accession Number
HLB01461717a

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

Date Prepared
March 7, 2017

Last Updated
N/A

Clinical Trial URLs
https://clinicaltrials.gov/ct2/s...

Primary Publication URLs
N/A

Study Website
https://www.spiromics.com/spirom...

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.

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.

Subjects

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 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

Study Population

Subjects:
  Frequency Percent Cumulative
Frequency
Cumulative
Percent
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
 
Age:
  Frequency Percent Cumulative
Frequency
Cumulative
Percent
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
 
Sex:
  Frequency Percent Cumulative
Frequency
Cumulative
Percent
Male 1520 52.83 1520 52.83
Female 1357 47.17 2877 100.00
 
Race:
  Frequency Percent Cumulative
Frequency
Cumulative
Percent
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
Frequency
Cumulative
Percent
Missing 1 0.03 1 0.03
Non-hispanic 2729 94.86 2730 94.89
Hispanic 147 5.11 2877 100.00
 
 

Available Biospecimens

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):
10/26/2018
 
  Baseline Baseline Repeatability Bronchoscopy Year 1 Year 3 Total
Serum 16746 605 0 15351 5938 38640
Plasma 37084 1282 0 32264 12325 82955
Bronchial Wash 0 0 191 0 0 191
Urine 13207 474 0 11030 4779 29490
BAL 0 0 1401 0 0 1401
Oral Wash 0 0 155 0 0 155
Sputum 1768 55 0 0 0 1823
Visits (Subjects):
10/26/2018
 
  Serum
Total number of subjects Average volume (mL) per subject
Baseline 2,721 1.58
Baseline Repeatability 91 1.76
Year 1 2,148 1.78
Year 3 822 1.77
 
  Plasma
Total number of subjects Average volume (mL) per subject
Baseline 2,728 4.44
Baseline Repeatability 91 4.71
Year 1 2,147 4.73
Year 3 821 4.62
 
  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 2,674 4.94
Baseline Repeatability 91 5.21
Year 1 2,097 5.26
Year 3 790 6.05
 
  BAL
Total number of subjects Average volume (mL) per subject
Bronchoscopy 156 7.31
 
  Oral Wash
Total number of subjects Average volume (mL) per subject
Bronchoscopy 155 9.99
 
  Sputum
Total number of subjects Average volume (mL) per subject
Baseline 887 2.09
Baseline Repeatability 28 2.22

Requests for Open BioLINCC Studies are submitted through this website. Click the Request button to begin.

Resources Available

Specimens and Study Datasets

Study Catalog

Study Publications (0)

Materials Available

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

Study Documents

  • PDF Data Dictionary (PDF - 14.0 MB)
  • PDF Forms (PDF - 8.7 MB)
  • PDF Protocol (PDF - 901.7 KB)
  • PDF 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.

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