Subpopulations and Intermediate Markers in COPD Study (SPIROMICS)

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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

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.

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 (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

Subjects:

There are 2,863 total subjects:

Non-smoker: 195
Smoker without COPD: 912
Mild/Moderate COPD: 1,159
Severe COPD: 597

Age:

 

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

Sex:

 

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

Race:

 

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

Material Types:

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

General Freeze/Thaw Status:

As of 02/08/2024, nearly all specimens are unthawed. Very few plasma and BAL specimens have undergone at least 1 freeze-thaw cycle.

Visits (Vials):

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

Visits (Subjects):

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

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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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