ClinicalTrials.gov Identifier: NCT01969344
Funding Statement: SPIROMICS is funded by the National Heart, Lung, and Blood Institute (NHLBI) and the COPD Foundation and is coordinated by the Collaborative Studies Coordinating Center at The University of North Carolina at Chapel Hill.
About the study
SPIROMICS is a collaborative research effort that includes prospective collection and analysis of phenotypic, biomarker, genetic, genomic, and clinical data from individuals with COPD or at risk for COPD or healthy participants for the purpose of identifying subpopulations and intermediate outcome measures that can be used in developing new therapies for COPD and for improving the clinical management of patients with COPD and related lung diseases.
A primary aim of SPIROMICS is to perform detailed molecular fingerprinting and extensive participant phenotyping to identify disease subpopulations and to identify and validate surrogate markers of disease severity and activity which will be useful as intermediate outcome measures for future clinical trials. Secondary aims are to increase our understanding of the natural history of COPD, to develop bioinformatic resources that will enable the utilization and sharing of data in studies of COPD and related diseases, and to create a collection of clinical, biomarker, radiographic, and genetic data that can be used by external investigators for other studies of COPD.
SPIROMICS is also creating a biorepository with a unique collection of clinical samples including sputum, bronchial lavage, bronchial wash, oral wash, plasma, serum, and urine. Additional information on the contents of the biorepository and how to access samples in the biorepository is available at this link: SPIROMICS BioLINCC.
SPIROMICS investigators contributed data for multiple working groups of the Chronic Lung Disease Biomarker and Clinical Outcome Assessment Qualification Consortium (CBQC).
The first phase of SPIROMICS (SPIROMICS I) has been completed and the study is currently in its second phase (SPIROMICS II) with planning for a third phase (SPIROMICS III) in progress.
As of June 2021, the SPIROMICS investigators and collaborators had published over 90 peer-reviewed research papers. The analyses of the SPIROMICS data have contributed to a better understanding of a number of important aspects of COPD. Among these are:
- An improved understanding and the disease burden in symptomatic smokers with normal lung function (pre-COPD). Woodruff PG, Barr RG, Bleecker E, et al; SPIROMICS Research Group. Clinical significance of symptoms in smokers with preserved pulmonary function. N Engl J Med. 2016;374:1811–1821. doi: https://doi.org/10.1056/NEJMoa1505971
- The importance of specific mucins and total mucin concentration in disease pathogenesis. Radicioni G, Ceppe A, Ford AA, et al. Airway mucin MUC5AC and MUC5B concentrations and the initiation and progression of chronic obstructive pulmonary disease: an analysis of the SPIROMICS cohort. Lancet Respir Med. 2021May 28:S2213-2600(21)00079-5. doi: https://doi.org/10.1016/S2213-2600(21)00079-5.
- The role of small airways disease in disease progression and important clinical outcomes. Boes JL, Hoff BA, Bule M, et al. Parametric response mapping monitors temporal changes on lung CT scans in the subpopulations and intermediate outcome measures in COPD Study (SPIROMICS). Acad Radiol. 2015 Feb;22(2):186-194. doi: https://doi.org/10.1016/j.acra.2014.08.015.
- The identification of several biomarkers that may facilitate the identification of patient subgroups for targeted therapies. Serban KA, Pratte KA, Bowler RP. Protein biomarkers for COPD outcomes. Chest. 2021 ;159(6):2244-2253. doi: https://doi.org/10.1016/j.chest.2021.01.004.
- The identification of a potential marker for COPD patients at increased risk for adverse lung outcome. Burkes RM, Ceppe AS, Couper DJ, et al. Plasma cathelicidin is independently associated with reduced lung function in COPD: analysis of the Subpopulations and Intermediate Outcome Measures In COPD Study Cohort. Chronic Obstr Pulm Dis. 2020;7(4):370-381. doi: https://doi.org/10.15326/jcopdf.7.4.2020.0142.
The above is only a partial list of results from SPIROMICS. A complete list of SPIROMICS publications can be found here (last accessed 30 June 2021): SPIROMICS Publications - Pubmed
The SPIROMICS II Industry Advisory Committee and The Role of the COPD Foundation
The SPIROMICS II Industry Advisory Committee (IAC) is a program of the COPD Foundation. The COPD Foundation manages the IAC, which entails management of finances, contracting with SPIROMICS II participating sites, and planning of quarterly SPIROMICS II IAC meetings. Funds provided by IAC members are used to support SPIROMICS II study-related costs not covered by the National Institutes of Health (NIH) grants. IAC members contract solely with the COPD Foundation for participation in the SPIROMICS II IAC. IAC members are invited to participate in the quarterly meetings and an annual SPIROMICS Steering Committee meeting. IAC members are able to propose ancillary studies and to interact with SPIROMICS investigators and leadership as outlined in the contract. The perspective provided by industry members is important in shaping many of the analyses of SPIROMICS data as well as influencing aspects of data collection.
A schematic of the relationships of the IAC in SPIROMICS II is shown in the figure below.
SPIROMICS Study of Early COPD Progression
There is a fundamental gap in understanding the early origins of COPD. The long-term goal of SPIROMICS Study of Early COPD Progression (also known as SOURCE) is to arrest COPD progression by understanding its earliest stages. SOURCE will recruit a new cohort of younger at-risk individuals to link chest imaging and pathologic abnormality with longitudinal disease progression, and thus, define potentially targetable mechanisms laying the foundation for developing disease-modifying therapies.
This project has two significant deliverables:
- identify potential mechanisms in younger participants who develop rapidly progressive COPD
- to speed up the availability of tests like computed tomography scans in clinical practice to identify disease progression in COPD
How do I join the SPIROMICS IAC?
The COPD Foundation, the NIH, and SPIROMICS leadership welcome the interest of potential new members to the SPIROMICS II IAC. For information on how to become an IAC member or for additional information on SPIROMICS, please contact one of the COPD Foundation contacts listed below.