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Study of COPD Subgroups and Biomarkers (SPIROMICS)

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ClinicalTrials.gov Identifier: NCT01969344
Recruitment Status : Active, not recruiting
First Posted : October 25, 2013
Last Update Posted : February 15, 2019
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
COPD Foundation
Columbia University
Johns Hopkins University
National Jewish Health
Temple University
University of Alabama at Birmingham
University of California, Los Angeles
University of California, San Francisco
University of Illinois at Chicago
University of Iowa
University of Michigan
University of Utah
Wake Forest University
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:

SPIROMICS I and SPIROMICS II are observational studies of Chronic Obstructive Pulmonary Disease (COPD).

SPIROMICS I had two main aims: (1) To find groups of patients with COPD who share certain characteristics; (2) To find new ways of measuring whether or not COPD is getting worse and so provide new ways of testing whether a new treatment is working.

SPIROMICS II has three primary aims. Aim 1 is to define the natural history of "Smokers with symptoms despite preserved spirometry" and characterize the airway mucus abnormalities underlying this condition. Aim 2 is to determine the radiographic precursor lesion(s) for emphysema, and identify the molecular phenotypes underlying airway disease and emphysema. Aim 3 is to advance understanding of the biology of COPD exacerbations through analysis of predisposing baseline phenotypes, exacerbation triggers and host inflammatory response.


Condition or disease
COPD Chronic Obstructive Pulmonary Disease Chronic Bronchitis Emphysema

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 2981 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Subpopulations and Intermediate Markers in COPD Study
Study Start Date : November 2010
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : July 31, 2023

Group/Cohort
Smokers without COPD
Current or former smokers with at least a 20 pack-year history with normal lung function based on post-bronchodilator spirometry (n=944).
Severe COPD
Current and former smokers with at least a 20 pack-year history with severe COPD based on post-bronchodilator spirometry (n=625).
Mild/Moderate COPD
Current and former smokers with at least a 20 pack-year history with mild to moderate COPD based on post-bronchodilator spirometry (n=1210).
Non-smokers
Never-smokers with normal lung function on spirometry without use of bronchodilators (n=201).



Primary Outcome Measures :
  1. Morbidity [ Time Frame: Up to end of follow-up (data presented up to month 36) ]
    Morbidity in SPIROMICS will primarily be measured by assessing acute exacerbations in the SPRIOMICS cohort.

  2. Lung Function [ Time Frame: Up to end of follow-up (data presented up to month 36) ]
    COPD is characterized by physiological problems, such as airflow limitations and abnormalities of gas exchange and lung hyperinflation. These features of lung function are accessed objectively in the laboratory setting using spirometry/plethysmography, which can measure such parameters as FEV1 (forced expiratory volume in one second), FVC (forced vital capacity or total volume of air exhaled after full inspiration), FRC (functional residual capacity or volume of gas remaining in the lung at the end of tidal expiration), and IC (inspiratory capacity or maximum volume of gas that can be inspired from end-tidal expiration). The FDA preferred primary endpoint for assessment of alteration in disease progression in COPD is serial measurements of FEV1 over three years.

  3. Mortality [ Time Frame: Up to end of follow-up (data presented up to month 36) ]
    Deaths of SPIROMICS participants will be identified during follow-up calls and attempts to schedule clinic exams during the three-year study period, and deaths will be recorded in the clinical database. The cause of death will be determined via chart review and adjudication, and deaths attributable to COPD worsening or exacerbation will be recorded as confirmed clinical endpoints, in addition to contributing to the endpoint of all-cause mortality.


Secondary Outcome Measures :
  1. Repeatability Substudy: Repeatability of clinic visit measurements [ Time Frame: Up to end of recruitment (2-6 week measurement repeatability) ]
    The repeatability of clinic visit measurements will be assessed at the end of this substudy. In this substudy all clinic procedures and samples are repeated/recollected 2-6 weeks after the baseline clinic visit in a subset of participants. This provides a measurement of short-term repeatability of these assessments.

  2. Exacerbation Substudy: Assess clinical and biological data in relation to an acute exacerbation [ Time Frame: Up to end of follow-up (data presented up to month 15) ]
    The exacerbation substudy will collect clinical and biological measurements during an acute exacerbation in a subset of participants. These will be used to better understand the biological processes underlying an acute exacerbation.

  3. Exacerbation Substudy: Assess symptomatic changes in COPD in relation to acute exacerbation [ Time Frame: Up to end of follow-up (data presented up to month 15) ]
    The exacerbation substudy will collect a daily symptom diary. Data from this daily diary will be used to characterize the stable versus exacerbative state in a subset of participants.

  4. Parametric Response Mapping in COPD: Structural assessment of the lung [ Time Frame: Up to end of follow-up (data presented up to month 36) ]
    In the PRM ancillary study, PRM metrics will be used to non-invasively evaluate the regional structural heterogeneity of the lung, including small airways disease and emphysema, and its relationship to clinical measurements.


Biospecimen Retention:   Samples With DNA
Whole blood, serum, plasma, urine, lung biopsies, lung bronchial wash and lavage fluid, oral rinse and tongue scrapping, and sputum


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Never-smokers, current and former smokers without COPD, and current and former smokers with COPD with access to one of the study clinical centers.
Criteria

Inclusion Criteria:

  • Between 40 and 80 at baseline visit
  • Never smokers: <1 pack-year history of smoking
  • Never smokers: Must meet lung function criteria based on spirometry without inhaled bronchodilators
  • Current or former smokers: >20 pack-year history of smoking
  • Current or former smokers: Must meet lung function criteria based on spirometry with inhaled bronchodilators

Exclusion Criteria:

  • Dementia or other cognitive dysfunction which in the opinion of the investigator would prevent the participant from consenting to the study or completing study procedures
  • Plans to leave the area in the next 3 years
  • Smoking history of > 1 pack-year but <21 pack-years
  • BMI > 40 kg/m2 at baseline exam
  • Prior significant difficulties with pulmonary function testing
  • Hypersensitivity to or intolerance of albuterol sulfate or ipratropium bromide or propellants or excipients of the inhalers
  • Non-COPD obstructive lung disease, severe kyphoscoliosis, neuromuscular weakness, or other conditions, including clinically significant cardiovascular and pulmonary disease, that, limit the interpretability of the pulmonary function measures.
  • History of Interstitial lung disease
  • History of Lung volume reduction surgery or lung resection
  • History of lung or other organ transplant
  • History of endobronchial valve therapy
  • History of large thoracic metal implants (e.g., AICD and/or pacemaker)
  • Currently taking >=10mg a day/20mg every other day of prednisone or equivalent systemic corticosteroid
  • Currently taking any immunosuppressive agent
  • Current illicit substance abuse, excluding marijuana
  • History of or current use of IV Ritalin
  • History of or current use of heroin
  • History of illegal IV drug use within the last 10 years or more than 5 instances of illegal IV drug use ever
  • Known HIV/AIDS infection
  • History of lung cancer or any cancer that spread to multiple locations in the body
  • History of or current exposure to chemotherapy or radiation treatments that, in the opinion of the investigator, limits the interpretability of the pulmonary function measures.
  • Diagnosis of unstable cardiovascular disease including myocardial infarction in the past 6 weeks, uncontrolled congestive heart failure, or uncontrolled arrhythmia
  • Any illness expected to cause mortality in the next 3 years
  • Active pulmonary infection, including tuberculosis
  • History of pulmonary embolism in the past 2 years
  • Known diagnosis of primary bronchiectasis
  • Currently institutionalized (e.g., prisons, long-term care facilities)
  • Known to be a first degree relative of another, already enrolled participant (i.e., biological parent, biological sibling)
  • Never smokers only: Current diagnosis of asthma
  • Women only: Cannot be pregnant at baseline or plan to become pregnant during the course of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01969344


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
United States, California
University of California at Los Angeles
Los Angeles, California, United States, 90095
University of California at San Francisco
San Francisco, California, United States, 94143
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21224
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, New York
Columbia University
New York, New York, United States, 10032
United States, North Carolina
Wake Forest University
Winston-Salem, North Carolina, United States, 27157
United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19140
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Heart, Lung, and Blood Institute (NHLBI)
COPD Foundation
Columbia University
Johns Hopkins University
National Jewish Health
Temple University
University of Alabama at Birmingham
University of California, Los Angeles
University of California, San Francisco
University of Illinois at Chicago
University of Iowa
University of Michigan
University of Utah
Wake Forest University
Investigators
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Principal Investigator: David Couper, PhD University of North Carolina, Chapel Hill
Principal Investigator: Graham Barr, PhD, MD Columbia University
Principal Investigator: Eugene Bleecker, MD University of Arizona
Principal Investigator: Robert Paine, MD University of Utah
Principal Investigator: Eric Hoffman, MD University of Iowa
Study Chair: Prescott Woodruff, MD University of California at San Francisco
Principal Investigator: Christopher Cooper, MD University of California at Los Angeles
Principal Investigator: MeiLan Han, MD University of Michigan
Principal Investigator: Russell Bowler, MD National Jewish Health
Principal Investigator: Alejandro Cornellas, MD University of Iowa
Principal Investigator: Gerard Criner, MD Temple University
Principal Investigator: Mark Dransfield, MD University of Alabama at Birmingham
Principal Investigator: Nadia Hansel, MD Johns Hopkins University
Principal Investigator: Jerry Krishnan, MD University of Illinois at Chicago
Principal Investigator: Stephen Peters, MD Wake Forest University

Additional Information:
Publications of Results:
Hobbs BD, de Jong K, Lamontagne M, Bossé Y, Shrine N, Artigas MS, Wain LV, Hall IP, Jackson VE, Wyss AB, London SJ, North KE, Franceschini N, Strachan DP, Beaty TH, Hokanson JE, Crapo JD, Castaldi PJ, Chase RP, Bartz TM, Heckbert SR, Psaty BM, Gharib SA, Zanen P, Lammers JW, Oudkerk M, Groen HJ, Locantore N, Tal-Singer R, Rennard SI, Vestbo J, Timens W, Paré PD, Latourelle JC, Dupuis J, O'Connor GT, Wilk JB, Kim WJ, Lee MK, Oh YM, Vonk JM, de Koning HJ, Leng S, Belinsky SA, Tesfaigzi Y, Manichaikul A, Wang XQ, Rich SS, Barr RG, Sparrow D, Litonjua AA, Bakke P, Gulsvik A, Lahousse L, Brusselle GG, Stricker BH, Uitterlinden AG, Ampleford EJ, Bleecker ER, Woodruff PG, Meyers DA, Qiao D, Lomas DA, Yim JJ, Kim DK, Hawrylkiewicz I, Sliwinski P, Hardin M, Fingerlin TE, Schwartz DA, Postma DS, MacNee W, Tobin MD, Silverman EK, Boezen HM, Cho MH; COPDGene Investigators; ECLIPSE Investigators; LifeLines Investigators; SPIROMICS Research Group; International COPD Genetics Network Investigators; UK BiLEVE Investigators; International COPD Genetics Consortium. Genetic loci associated with chronic obstructive pulmonary disease overlap with loci for lung function and pulmonary fibrosis. Nat Genet. 2017 Mar;49(3):426-432. doi: 10.1038/ng.3752. Epub 2017 Feb 6.

Other Publications:

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01969344     History of Changes
Other Study ID Numbers: 10-0048
HHSN268200900020C ( Other Identifier: National Heart, Lung, and Blood Institute )
HHSN268200900013C ( Other Identifier: National Heart, Lung, and Blood Institute )
HHSN268200900014C ( Other Identifier: National Heart, Lung, and Blood Institute )
HHSN268200900015C ( Other Identifier: National Heart, Lung, and Blood Institute )
HHSN268200900016C ( Other Identifier: National Heart, Lung, and Blood Institute )
HHSN268200900017C ( Other Identifier: National Heart, Lung, and Blood Institute )
HHSN268200900018C ( Other Identifier: National Heart, Lung, and Blood Institute )
HHSN2682009000019C ( Other Identifier: National Heart, Lung, and Blood Institute )
5U01HL137880 ( U.S. NIH Grant/Contract )
1U24HL141762 ( U.S. NIH Grant/Contract )
First Posted: October 25, 2013    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All data collected in SPIROMICS I have been submitted to the NHLBI data repository (BioLINCC). Updates will be submitted regularly during SPIROMICS II
Supporting Materials: Study Protocol
Time Frame: Data from SPIROMICS I are currently available and will remain available indefinitely.
Access Criteria:

Access criteria for data from BioLINCC are determined by NHLBI, not by the SPIROMICS Investigators.

Criteria for obtaining data directly from SPIROMICS are provided on the web site given below.

URL: http://www2.cscc.unc.edu/spiromics/obtaining-data
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bronchitis
Bronchitis, Chronic
Emphysema
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes
Bronchial Diseases
Respiratory Tract Infections