Overview

This trial is active, not recruiting.

Conditions copd, chronic obstructive pulmonary disease, chronic bronchitis, emphysema
Sponsor University of North Carolina, Chapel Hill
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date November 2010
End date July 2016
Trial size 3200 participants
Trial identifier NCT01969344, 10-0048, HHSN2682009000019C, HHSN268200900013C, HHSN268200900014C, HHSN268200900015C, HHSN268200900016C, HHSN268200900017C, HHSN268200900018C, HHSN268200900020C

Summary

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:

1. 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.

2. 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.

3. 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:

1. 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.

2. 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Nine hundred current or former smokers with at least a 20 pack-year history with normal lung function based on post-bronchodilator spirometry.
Six hundred current and former smokers with at least a 20 pack-year history with sever COPD based on post-bronchodilator spirometry.
Fifteen hundred current and former smokers with at least a 20 pack-year history with mild to moderate COPD based on post-bronchodilator spirometry.
Two hundred never-smokers with normal lung function on spirometry without use of bronchodilators.

Primary Outcomes

Measure
Morbidity
time frame: Up to end of follow-up (data presented up to month 36)
Lung Function
time frame: Up to end of follow-up (data presented up to month 36)
Mortality
time frame: Up to end of follow-up (data presented up to month 36)

Secondary Outcomes

Measure
Repeatability Substudy: Repeatability of clinic visit measurements
time frame: Up to end of recruitment (2-6 week measurement repeatability)
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)
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)
Parametric Response Mapping in COPD: Structural assessment of the lung
time frame: Up to end of follow-up (data presented up to month 36)

Eligibility Criteria

Male or female participants from 40 years up to 80 years old.

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

Additional Information

Official title Subpopulations and Intermediate Markers in COPD Study
Principal investigator David Couper, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill.