Subpopulations and Intermediate Markers in COPD Study (SPIROMICS) - Catalog

Name

Subpopulations and Intermediate Markers in COPD Study (SPIROMICS)

Accession Number

HLB01461719a

Acronym

SPIROMICS

Related studies

BSI Study IDs

SPR

Is public use dataset

False

Keywords

Has Study Datasets

True

Has Specimens

True

Specimen ID Type

Coded

Study Website

https://www.spiromics.com/spiromics/

The Framingham Heart Study Group requires that the requestor must obtain full or expedited IRB/Ethics Committee review and approval to obtain these data. Waivers or a determination that the research is exempt from ethical regulations do not suffice.

False

Study type

Epidemiology Study

Collection Type

Open BioLINCC Study

Cohort type

Adult

Interventions

Study Open Date (Data)

2017-04-21

Study Open Date (Specimens)

2017-04-21

Date materials available

2017-03-07

Last updated

None

Study period

November 2010 – July 2018

Study Contacts
NHLBI Division

DLD

Classification

Lung

HIV study classification

non-HIV

COVID study classification

non-COVID

Pre-Website # of Specimens Shipped

None

# of Returned Specimens

None

Primary Publication URLs
N/A
Conditions

Chronic Bronchitis
Chronic Obstructive Pulmonary Disease
Emphysema

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.

Conclusions

Disease classification

Publications

Mat types

Bronchial Lavage
Bronchial Wash
Oral Wash (Saline)
Plasma
Serum
Sputum
Urine

Network

The study population available in BioLINCC study data may be lower than total study enrollment due to Informed Consent restrictions and other factors.

  • Subjects

    There are 2,863 total subjects:

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


    Last Modified: Feb. 8, 2024, 11:10 a.m.
  • 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


    Last Modified: Feb. 8, 2024, 11:10 a.m.
  • 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


    Last Modified: Feb. 8, 2024, 11:10 a.m.
  • 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


    Last Modified: Feb. 8, 2024, 11:10 a.m.

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 3.0 of the BioLINCC Handbook describes the components of the review process.

  • Material Types

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


    Last Modified: April 21, 2017, 11:17 a.m.
  • 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.


    Last Modified: Feb. 8, 2024, 11:10 a.m.
  • 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


    Last Modified: Feb. 8, 2024, 11:12 a.m.
  • 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


    Last Modified: Feb. 8, 2024, 11:10 a.m.