|NHLBI and CMS Launch Large Study of Home Oxygen
Therapy for COPD — Clinical Trial Will Clarify If More
Patients Could Benefit from Treatment
The National Heart, Lung, and Blood Institute (NHLBI), one of
the National Institutes of Health (NIH), and the Centers for Medicare & Medicaid
Services (CMS) is launching the largest randomized clinical trial
of the effectiveness and safety of long-term, home oxygen therapy
for COPD (chronic obstructive pulmonary disease). The six-year,
$28 million project will study patients with moderate disease.
COPD, a lung disease that over time makes it hard to breathe,
is the fourth leading cause of death in the United States. In the
Long-term Oxygen Treatment Trial, researchers at 14 clinical centers
across the United States will study approximately 3,500 patients
with moderate COPD to determine whether supplemental oxygen will
help them lead longer, more active, and better quality lives. The
results will help Medicare decide whether to extend coverage for
home oxygen treatment to patients with moderate disease. Currently,
Medicare limits coverage of home oxygen therapy to beneficiaries
with severe COPD (very low blood oxygen levels while resting).
NHLBI will administer and oversee the study, and Medicare will
cover the costs of items and medical services that are generally
available through that program to beneficiaries enrolled in the
trial. NIH and CMS are agencies of the U.S. Department of Health
and Human Services (HHS).
“COPD is a devastating, highly disabling disease. The prospect
that home oxygen therapy could lessen the disability of COPD and
perhaps even prolong life when given earlier during the course
of the disease is enticing, but we need more information to determine
the risks and benefits,” said NHLBI Director Elizabeth G. Nabel,
M.D. “This study will provide important information to help patients
and their health providers decide whether home oxygen treatment
is a good choice for them.”
About 12 million adults in the United States have been diagnosed
with COPD, and another 12 million are believed to be undiagnosed.
Approximately one million COPD patients currently receive supplemental
oxygen treatment. Although oxygen therapy has been shown to improve
survival in patients with severe COPD, the effects of treatment
have not been adequately studied in patients with less severe disease.
The decision to undertake the study evolved from a scientific
working group convened in May 2004 by NHLBI in cooperation with
CMS and HHS' Agency for Healthcare Research and Quality. The group
called for more research on the safety and efficacy of long-term
oxygen therapy in patients with COPD. In March, Medicare announced
that it will extend coverage of home oxygen treatment to Medicare-eligible
patients enrolled in the study, who would not otherwise be covered.
“Medicare is committed to ensure that beneficiaries have access
to the most appropriate treatments based on the best available
science,” commented CMS Chief Clinical Officer Barry Straube, M.D. “The
results of this study will improve our understanding of the effects
of oxygen treatment in a broader group of COPD patients and will
help guide our policy decisions."
Patient recruitment for the Long-term Oxygen Treatment Trial is
expected to begin in late 2007. Participants will be randomly selected
to receive or not to receive supplemental oxygen for approximately
three years. All participants will be periodically monitored; those
who are not initially selected to receive oxygen will be prescribed
oxygen if their blood oxygen levels worsen during the trial.
The 14 field study sites awarded contracts are
- Brigham & Women’s Hospital (John Reilly, M.D., Principal Investigator)
- Cleveland Clinic Foundation (James Stoller, M.D., M.S., Principal
- Denver Health Medical Center (Rick Albert, M.D., Principal
- Duke University (Neil MacIntyre, M.D., Principal Investigator)
- Kaiser Permanente Northwest (Thomas Stibolt, M.D., Principal
- Los Angeles Biomedical Research Institute (Richard Casaburi,
M.D., Principal Investigator)
- Ohio State University (Philip Diaz, M.D., Principal Investigator)
- Temple University (Gerard Criner, M.D., Principal Investigator)
- University of Alabama at Birmingham (J. Allen Cooper, Jr.,
M.D., Principal Investigator)
- University of Michigan (Fernando J. Martinez, M.D., M.S., Principal
- University of Pittsburgh (Frank Sciurba, M.D., Principal Investigator)
- University of Utah (Richard Kanner, M.D., Principal Investigator)
- University of Washington (David Au, M.D., M.S., Principal Investigator)
- Washington University (Roger Yusen, M.D., M.P.H., Principal
NHLBI awarded the contract for the study’s data coordinating center
to Johns Hopkins University (Steven Piantadosi, MD, PhD, Principal
COPD is usually caused by smoking or by long-term exposure to
dust or fumes. Symptoms include regular coughing (sometimes called "smoker's
cough"), shortness of breath, excess sputum production, feeling
like you can't breathe, not being able to take a deep breath, and
wheezing. Quitting smoking is the single most important step patients
can take to reduce the risk of developing COPD and to slow the
progress of the disease.
Other treatments can help manage patients’ symptoms, lower the
rate of serious complications, and improve quality of life. Such
treatments include exercise rehabilitation, medications such as
bronchodilators and inhaled steroids to help open airways, supportive
and preventive measures such as flu shots and pneumonia vaccine,
and prompt treatment of respiratory infections. A limited number
of patients with severe COPD may also benefit from lung volume
reduction surgery (LVRS) or other surgeries.
NHLBI and CMS previously collaborated on the landmark study that
determined which patients with severe COPD are most likely to benefit
from or suffer complications from LVRS. Findings from the National
Emphysema Treatment Trial were reported in May 2003, and Medicare
subsequently began coverage of the procedure based on the results.
"As the population ages, the number of individuals affected by
COPD is on the rise," noted James Kiley, PhD., director of the
NHLBI Division of Lung Diseases. "It is more imperative than ever
that we find treatments that will improve the health and function
of patients with chronic lung diseases such as COPD."
November is National COPD Awareness Month. In addition, NHLBI
is developing a national educational campaign to increase awareness
and understanding of COPD and its risk factors and to underscore
the benefits of early detection and treatment in slowing the disease
and improving the quality of life.
To interview Thomas Croxton, M.D., Ph.D., NHLBI project officer
of the study, contact the NHLBI Communications Office at 301-496-4236.
To interview Dr. Reilly, call Kevin Myron at 617-534-1605; to interview
Dr. Stoller, call Erinne Dyer at 216-444-8168 or Dr. Stoller at
216-444-1960; to interview Dr. Albert, call Lynn Ercolani at 303-436-6606;
to interview Dr. MacIntyre, call Marla Broadfoot at 919-660-1306;
to interview Dr. Stibolt, call Terry Fitzpatrick at 503-335-6602;
to interview Dr. Casaburi, call David Feuerherd at 310-215-0234;
to interview Dr. Diaz, call Sherri Kirk at 614-293-3737; to interview
Dr. Criner, call Eryn Jelesiewicz at 215-707-0730; to interview
Dr. Cooper, call Bob Shepard at 205-934-8934; to interview Dr.
Martinez, call Katie Gazella at 734-764-2220; to interview Dr.
Sciurba, call Michele Baum at 412-647-3555; to interview Dr. Kanner,
call Chris Nelson at 801-581-7387; to interview Dr. Au, call Clare
Hagerty at 206-685-1323; to interview Dr. Yusen, call Joni Westerhouse
at 314-286-0120; to interview Dr. Piantadosi, call David Marsh
Part of the National Institutes of Health, the National Heart,
Lung, and Blood Institute (NHLBI) plans, conducts, and supports
research related to the causes, prevention, diagnosis, and treatment
of heart, blood vessel, lung, and blood diseases; and sleep disorders.
The Institute also administers national health education campaigns
on women and heart disease, healthy weight for children, and
other topics. NHLBI press releases and other materials are available
online at: www.nhlbi.nih.gov.
The National Institutes of Health (NIH) — The Nation's
Medical Research Agency — includes 27 Institutes and
Centers and is a component of the U.S. Department of Health and
Human Services. It is the primary federal agency for conducting
and supporting basic, clinical and translational medical research,
and it investigates the causes, treatments, and cures for both
common and rare diseases. For more information about NIH and
its programs, visit www.nih.gov.