Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
3200

Summary

Conditions
  • Chronic Bronchitis
  • Chronic Obstructive Pulmonary Disease
  • COPD
  • Emphysema
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 40 years and 80 years
Gender
Both males and females

Description

SPIROMICS was initially funded through contracts from the NIH. That phase of SPIROMICS is now referred to as SPIROMICS I. SPIROMICS is now funded as a grant from the NIH. The current phase is referred to as SPIROMICS II. Brief summary of SPIROMICS I: The purpose of SPIROMICS is to learn about chroni...

SPIROMICS was initially funded through contracts from the NIH. That phase of SPIROMICS is now referred to as SPIROMICS I. SPIROMICS is now funded as a grant from the NIH. The current phase is referred to as SPIROMICS II. Brief summary of SPIROMICS I: 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. SPIROMICS has three substudies and two ancillary studies. Substudies: Repeatability Substudy: The entire baseline clinic visit will be repeated on 100 volunteers. The goal of this substudy is to determine reliability of measurement procedures. Bronchoscopy Substudy: 300 participants will be enrolled for two additional study visits, including a bronchoscopy. The goal of this substudy is to collect and assess biological specimens and relate those results to clinical measurements. Exacerbation Substudy: Up to 400 participants will be enrolled in this substudy. A daily symptom diary will be collected on all participants. Participants will also be seen in the clinic during a pulmonary exacerbation. The goals of this substudy are to 1) better understand the relationship between symptoms and exacerbations and 2) obtain clinical data and specimens during a pulmonary exacerbation. Ancillary Studies: Air Pollution Ancillary Study: The SPIROMICS Air Pollution ancillary study uses state-of-the art air pollution exposure assessments to determine individual-level outdoor and indoor air pollution exposure. The goals of this substudy are to determine the effect of long-term air pollution exposure on COPD morbidity and to determine whether short-term changes in outdoor air pollution are associated with changes in COPD morbidity. Parametric Response Mapping in COPD: The Parametric Response Mapping (PRM) in COPD ancillary study collects an additional CT scan during the final study visit and uses a new analysis technique (PRM) to assess the functional small airways of the lung and emphysema. Brief summary of SPIROMICS II: 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. SPIROMICS II will continue follow-up of current participants, with no new enrollment. Each participant will have one clinic visit and will be contacted by telephone every 4 months.

Tracking Information

NCT #
NCT01969344
Collaborators
  • Johns Hopkins University
  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Utah
  • COPD Foundation
  • Columbia University
  • National Jewish Health
  • Temple University
  • University of Alabama at Birmingham
  • University of Michigan
  • Wake Forest University
  • University of California, Los Angeles
  • University of California, San Francisco
  • University of Illinois at Chicago
  • University of Iowa
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 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: Igor Barjaktarevic, 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