Study of COPD Subgroups and Biomarkers



Status:Active, not recruiting
Conditions:Bronchitis, Chronic Obstructive Pulmonary Disease, Chronic Obstructive Pulmonary Disease, Pulmonary, Pulmonary, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - 80
Updated:2/17/2019
Start Date:November 2010
End Date:July 31, 2023

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Subpopulations and Intermediate Markers in COPD Study

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.

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:

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.

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.

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
We found this trial at
12
sites
Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Baltimore, MD
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Iowa City, IA
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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New York, NY
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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Salt Lake City, UT
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Ann Arbor, MI
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2035 W Taylor St
Chicago, Illinois
(312) 996-4350
University of Illinois at Chicago A major research university in the heart of one of...
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Chicago, IL
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1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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Denver, CO
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1801 N Broad St
Philadelphia, Pennsylvania 19122
(215) 204-7000
Temple University Temple University is many things to many people. A place to pursue life's...
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Philadelphia, PA
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San Francisco, California 94143
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Winston-Salem, North Carolina 27157
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Winston-Salem, NC
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