Journal article
Design of the SPIROMICS Study of Early COPD Progression: SOURCE Study
Chronic obstructive pulmonary diseases, Vol.11(5), pp.444-459
09/2024
DOI: 10.15326/jcopdf.2023.0490
PMCID: PMC11548966
PMID: 39159077
Abstract
The biological mechanisms leading some tobacco-exposed individuals to develop early-stage chronic obstructive pulmonary disease (COPD) are poorly understood. This knowledge gap hampers development of disease-modifying agents for this prevalent condition. Accord-ingly, with National Heart, Lung and Blood Institute support, we initiated the SPIROMICS Study of Early COPD Progression (SOURCE), a multicenter observational cohort study of younger individuals with a history of cigarette smoking and thus at-risk for, or with, early-stage COPD. Our overall objectives are to identify those who will develop COPD earlier in life, characterize them thoroughly, and by contrasting them to those not developing COPD, define mechanisms of disease progression. SOURCE utilizes the established SPIROMICS clinical network. Its goal is to enroll n=649 participants, ages 30-55 years, all races/ethnicities, with ≥10 pack-years cigarette smoking, in either Global Initiative for Chronic Obstructive Lung Disease (GOLD) groups 0-2 or with Preserved Ratio Impaired Spirometry (PRISm); and an additional n=40 never-smoker controls. Participants undergo baseline and three-year follow-up visits, each including high-resolution computed tomography; respiratory oscillometry and spirometry (pre- and post-bronchodilator administration), exhaled breath condensate (baseline only); and extensive biospecimen collection, including sputum induction. Symptoms, interim healthcare utilization, and exacerbations are captured every six months via follow-up phone calls. An embedded bronchoscopy sub-study involving n=100 participants (including all never-smokers) will allow collection of lower airway samples for genetic, epigenetic, genomic, immunological, microbiome, mucin analyses, and basal cell culture. SOURCE should provide novel insights into the natural history of lung disease in younger individuals with a smoking history, and its biological basis.The biological mechanisms leading some tobacco-exposed individuals to develop early-stage chronic obstructive pulmonary disease (COPD) are poorly understood. This knowledge gap hampers development of disease-modifying agents for this prevalent condition. Accord-ingly, with National Heart, Lung and Blood Institute support, we initiated the SPIROMICS Study of Early COPD Progression (SOURCE), a multicenter observational cohort study of younger individuals with a history of cigarette smoking and thus at-risk for, or with, early-stage COPD. Our overall objectives are to identify those who will develop COPD earlier in life, characterize them thoroughly, and by contrasting them to those not developing COPD, define mechanisms of disease progression. SOURCE utilizes the established SPIROMICS clinical network. Its goal is to enroll n=649 participants, ages 30-55 years, all races/ethnicities, with ≥10 pack-years cigarette smoking, in either Global Initiative for Chronic Obstructive Lung Disease (GOLD) groups 0-2 or with Preserved Ratio Impaired Spirometry (PRISm); and an additional n=40 never-smoker controls. Participants undergo baseline and three-year follow-up visits, each including high-resolution computed tomography; respiratory oscillometry and spirometry (pre- and post-bronchodilator administration), exhaled breath condensate (baseline only); and extensive biospecimen collection, including sputum induction. Symptoms, interim healthcare utilization, and exacerbations are captured every six months via follow-up phone calls. An embedded bronchoscopy sub-study involving n=100 participants (including all never-smokers) will allow collection of lower airway samples for genetic, epigenetic, genomic, immunological, microbiome, mucin analyses, and basal cell culture. SOURCE should provide novel insights into the natural history of lung disease in younger individuals with a smoking history, and its biological basis.
Details
- Title: Subtitle
- Design of the SPIROMICS Study of Early COPD Progression: SOURCE Study
- Creators
- Jeffrey L Curtis - University of MichiganLori A Bateman - University of North Carolina at Chapel HillSusan Murray - University of MichiganDavid J Couper - University of North Carolina at Chapel HillWassim W Labaki - University of MichiganChristine M Freeman - University of MichiganKelly B Arnold - University of MichiganStephanie A Christenson - University of California, San FranciscoNeil E Alexis - University of North Carolina at Chapel HillMehmet Kesimer - University of North Carolina at Chapel HillRichard C Boucher - University of North Carolina at Chapel HillRobert J Kaner - New York Hospital QueensIgor Barjaktarevic - University of California, Los AngelesChristopher B Cooper - University of California, Los AngelesEric A Hoffman - University of IowaR Graham Barr - Columbia University Irving Medical CenterEugene R Bleecker - Mayo Clinic in ArizonaRussell P Bowler - National Jewish HealthAlejandro Comellas - University of IowaMark T Dransfield - University of Alabama at BirminghamMichael B Freedman - University of Illinois ChicagoNadia N Hansel - Johns Hopkins UniversityJerry A Krishnan - University of Illinois ChicagoNathaniel Marchetti - Temple UniversityDeborah A Meyers - National Jewish HealthJill Ohar - Wake Forest UniversityWanda K O'Neal - University of North Carolina at Chapel HillVictor E Ortega - Mayo Clinic in ArizonaRobert Paine III - University of Utah Health CareStephen P Peters - Wake Forest UniversityBenjamin M Smith - Columbia University Irving Medical CenterJadwiga A Wedzicha - Imperial College LondonJ Michael Wells - University of IowaPrescott G Woodruff - University of California, San FranciscoMeiLan K Han - University of MichiganFernando J Martinez - New York Hospital Queens
- Resource Type
- Journal article
- Publication Details
- Chronic obstructive pulmonary diseases, Vol.11(5), pp.444-459
- DOI
- 10.15326/jcopdf.2023.0490
- PMID
- 39159077
- PMCID
- PMC11548966
- NLM abbreviation
- Chronic Obstr Pulm Dis
- ISSN
- 2372-952X
- eISSN
- 2372-952X
- Publisher
- COPD FOUNDATION
- Grant note
Author contributions: JLC takes responsibility for the overall content as guarantor. The manuscript was written primarily by JLC and LAB, based on the study protocol (unpublished) . FJM, MKH, and JLC, as cochairs of the SOURCE Executive Committee, led development of the study protocol. All authors engaged in planning various aspects of the study and all authors reviewed the manuscript, provided feedback, and approved the final version.
- Language
- English
- Electronic publication date
- 08/16/2024
- Date published
- 09/2024
- Academic Unit
- Roy J. Carver Department of Biomedical Engineering; Radiology; Pulmonary, Critical Care, and Occupational Medicine; ICTS; Internal Medicine
- Record Identifier
- 9984697360002771
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