Trial record 2 of 18 for:    bronchitis | Open Studies | NIH, U.S. Fed

Study of COPD Subgroups and Biomarkers (SPIROMICS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of North Carolina, Chapel Hill
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01969344
First received: October 16, 2013
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

The purpose of SPIROMICS is to learn about chronic obstructive pulmonary disease (COPD), which is sometimes called emphysema or chronic bronchitis. Millions of Americans have COPD, and it is the fourth leading cause of death in the country. The most common cause of COPD is cigarette smoking, although not all smokers get COPD. The discovery of new treatments for COPD has been slowed by a poor understanding of different types of COPD and a lack of ways to measure whether or not COPD is getting worse.

The study has two main goals. The first is to find groups of patients with COPD who share certain characteristics. Certain groups may respond differently to certain treatments. The second is to find new ways of measuring whether or not COPD is getting worse. This would provide new ways of testing whether a new treatment is working.


Condition
COPD
Chronic Obstructive Pulmonary Disease
Chronic Bronchitis
Emphysema

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Subpopulations and Intermediate Markers in COPD Study

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Morbidity [ Time Frame: Participants will be followed for an average of three years ] [ Designated as safety issue: No ]
    Morbidity in SPIROMICS will primarily be measured by assessing acute exacerbations in the SPRIOMICS cohort.

  • Lung Function [ Time Frame: Participants will be followed for an average of three years ] [ Designated as safety issue: No ]
    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.

  • Mortality [ Time Frame: Participants will be followed for an average of three years ] [ Designated as safety issue: No ]
    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.


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


Estimated Enrollment: 3200
Study Start Date: November 2010
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Smokers without COPD
Nine hundred current or former smokers with at least a 20 pack-year history with normal lung function based on post-bronchodilator spirometry.
Severe COPD
Six hundred current and former smokers with at least a 20 pack-year history with sever COPD based on post-bronchodilator spirometry.
Mild/Moderate COPD
Fifteen hundred current and former smokers with at least a 20 pack-year history with mild to moderate COPD based on post-bronchodilator spirometry.
Non-smokers
Two hundred never-smokers with normal lung function on spirometry without use of bronchodilators.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01969344

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35249
Contact: Necole Harris    205-934-9240      
Principal Investigator: Mark Dransfield, MD         
United States, California
University of California at Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Marietta Wadley    310-825-3509      
Principal Investigator: Eric Kleerup, MD         
University of California at San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Chris Kirby    415-476-5125      
Principal Investigator: Prescott Woodruff, MD         
United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: Christina Schnell    303-398-1772      
Principal Investigator: Russ Bowler, MD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21224
Contact: Rebecca Forney    410-550-2593      
Principal Investigator: Nadia Hansel, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Cheryl Majors    734-764-7388      
Principal Investigator: Fernando Martinez, MD         
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Casandra Almonte    212-342-4162      
Principal Investigator: Graham Barr, PhD, MD         
United States, North Carolina
Wake Forest University Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Penny Spernoga    336-713-8553      
Principal Investigator: Eugene Bleecker, MD         
United States, Pennsylvania
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Barbara Macdonald    215-707-9610      
Principal Investigator: Gerald Criner, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Martin Villegas    801-581-5864      
Principal Investigator: Richard Kanner, MD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: David Couper, PhD University of North Carolina, Chapel Hill
Principal Investigator: Graham Barr, PhD, MD Columbia University
Principal Investigator: Eugene Bleecker, MD Wake Forest School of Medicine
Principal Investigator: Fernando Martinez, MD University of Michigan
Principal Investigator: Richard Kanner, MD University of Utah
Principal Investigator: Eric Hoffman, MD University of Iowa
Principal Investigator: Prescott Woodruff, MD University of California at San Francisco
Principal Investigator: Eric Kleerup, MD University of California at Los Angeles
Study Chair: Steve Rennard, MD University of Nebraska
  More Information

Additional Information:
No publications provided

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01969344     History of Changes
Other Study ID Numbers: 10-0048, HHSN268200900020C, HHSN268200900013C, HHSN268200900014C, HHSN268200900015C, HHSN268200900016C, HHSN268200900017C, HHSN268200900018C, HHSN2682009000019C
Study First Received: October 16, 2013
Last Updated: April 24, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Bronchitis
Bronchitis, Chronic
Emphysema
Pulmonary Emphysema
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014