(PORTLAND, Ore.) - The National Heart, Lung, and Blood Institute (NHLBI) today announced that it is awarding $28 million to 15 research institutions throughout the United States to conduct the Long-term Oxygen Treatment Trial (LOTT). This new study is the largest randomized clinical trial ever conducted on the effectiveness and safety of long-term, home oxygen therapy for patients with chronic obstructive pulmonary disease (COPD). The study is supported by NHLBI and the Centers for Medicare & Medicaid Services (CMS). Kaiser Permanente's Center for Health Research (CHR), located in Portland, has been selected as one of the study's 14 clinical centers and will receive $2.76 million to carry out the six-year study.

COPD, a lung disease that over time makes it hard to breathe, is the fourth leading cause of death in the United States. Nearly 12 million adults Americans have been diagnosed with COPD, and another 12 million are believed to be undiagnosed. Approximately one million COPD patients currently receive supplemental oxygen treatment. COPD is usually caused by smoking or by long-term exposure to dust or fumes. Symptoms include regular coughing, shortness of breath, excess sputum production, not being able to take a deep breath, and wheezing.

Finding the best treatments and clinical management practices for COPD is a very high research and medical priority. Previous research has found that long-term treatment with supplemental oxygen improves survival in patients with severe COPD (very low blood oxygen levels while resting). However, there is a lack of scientific evidence about the effectiveness of long-term oxygen treatment in patients with moderate COPD. Results of the new study will help Medicare decide whether to extend coverage for home oxygen therapy to this group of COPD patients. Currently, Medicare covers home oxygen therapy only for beneficiaries with severe COPD.

"This is a very important study," says Thomas Stibolt, MD, principal investigator for the study at CHR and senior physician, pulmonary and critical care at Kaiser Permanente Northwest, "because it will expand our knowledge about the possible benefits of oxygen therapy for patients with moderate COPD. It will help physicians better understand whether oxygen therapy will increase survival for this very large group of patients and whether it will improve such quality of life issues as appetite, exercise capability, cognitive functioning, and depression."

"We are very pleased to have been chosen to participate in this study," Dr. Stibolt adds. "Kaiser Permanente Northwest and the Center for Health Research have a long history of doing important clinical trials on health issues that affect millions of people. Due to our state-of-the-art electronic health record system, we also have the ability to identify and contact patients with COPD to ask them if they would like to participate in this study."

Nationwide, nearly 3,500 individuals with COPD are expected to participate in the study. Patient recruitment is expected to begin in late 2007. In this area, Dr. Stibolt and his research team will recruit 250 participants who are Kaiser Permanente members living in Oregon and Southwest Washington. Participants will be randomly selected to receive or not 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 study.

The primary aim of the study is to test whether long-term oxygen therapy improves survival among individuals with COPD who have moderate hypoxemia and increased risk of death compared to similar individuals who do not receive long-term oxygen therapy. Secondary aims include quality of life, exercise capacity, COPD hospitalizations, and cognitive function. Several substudies will address the impact of the intervention in selected subgroups of participants and will identify factors that influence responsiveness to the therapy.

Johns Hopkins University was selected by NHLBI to serve as the study's coordinating center. Other institutions selected to serve as the study's clinical centers are:

• Brigham & Women's Hospital
• Cleveland Clinic Foundation
• Denver Health Medical Center
• Duke University
• Los Angeles Biomedical Research Institute
• Ohio State University
• Temple University
• University of Alabama
• University of Michigan
• University of Pittsburgh
• University of Utah
• University of Washington
• Washington University

Kaiser Permanente's Center for Health Research, founded in 1964, is a non-profit research institution dedicated to "advancing knowledge to improve health." Kaiser Permanente Northwest is a prepaid group practice health care organization serving the medical needs of 485,000 people in Oregon and Southwest Washington.  

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Released: November 20, 2006