Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Effectiveness of Long-term Oxygen Therapy in Treating People With Chronic Obstructive Pulmonary Disease
Chronic obstructive pulmonary disease (COPD) is a serious respiratory disease in which the airways in the lungs are partially blocked, resulting in symptoms of chest tightness, coughing, and difficulty breathing. Currently, there are many available treatments for managing COPD symptoms and improving quality of life, including medications, lifestyle changes, oxygen therapy, and pulmonary rehabilitation. For people with severe COPD that is characterized by very low blood oxygen levels at rest, long term oxygen therapy can help to prolong life and promote feelings of well-being. However, the effectiveness of supplemental oxygen therapy for people with COPD that is characterized by only moderately low blood oxygen levels at rest or normal blood oxygen at rest and desaturation on exercise is not known. This study will evaluate the effectiveness of supplemental oxygen therapy in treating people with COPD who have moderately low blood oxygen levels at rest or who have normal blood oxygen levels at rest, but have low or very low blood oxygen levels during exercise.
COPD is the fourth leading cause of death in the United States, with more than 12 million
people currently diagnosed with the disease. Risk factors for COPD include smoking,
environmental exposure to lung irritants, and genetic predisposition. People with COPD often
experience symptoms of chronic cough, shortness of breath, excess mucus production, and
wheezing. In COPD, the airways in the lungs are chronically obstructed, and if left
untreated, this obstruction can cause significant damage to the lungs and lasting
disability. The quality of life of a person with COPD decreases as the disease progresses,
making treating and managing COPD in the moderate stages important. Long-term oxygen therapy
has been shown to help people with severe COPD that is characterized by very low blood
oxygen levels at rest to live longer and healthier lives. This study will determine whether
supplemental oxygen therapy is helpful for people with COPD that is characterized by
moderately low blood oxygen levels at rest or normal oxygen levels at rest and low or very
low levels during exercise.
Participation in this study will last at least one year and up to 7 years. Potential
participants will first undergo a screening visit that will include questionnaires, a
breathing test, measurements of resting and walking blood oxygen levels, a brief physical
exam, and a blood draw. Eligible participants will then return for a second screening visit,
during which they will complete more questionnaires. At the end of the second visit,
eligible participants will be assigned randomly to supplemental oxygen therapy or no oxygen
therapy.
Participants assigned to supplemental oxygen therapy will receive stationary and portable
oxygen systems. Shortly after receiving the portable oxygen system, participants will return
for a 1-hour visit to determine how much oxygen to use while walking and to learn how to use
the equipment. Participants who have low blood oxygen levels during rest will be instructed
to use supplemental oxygen 24 hours per day. Patients with normal resting blood oxygen
levels, but low or very low blood oxygen levels during exercise will be instructed to use it
during physical activity and sleep. Throughout the treatment period, participants will be
asked to keep records of the number of oxygen tanks emptied or pounds of oxygen delivered,
meter readings, and changes in equipment. Study officials will contact participants weekly
for the first month, monthly for the next 5 months, and then every 2 months until the Year 1
study visit. Participants will also complete a form about their oxygen equipment and usage
every 2 months. Participants assigned to receive no oxygen treatment will be contacted 1
week after study group assignment for a check-up.
All participants will return for study visits once a year for up to 7 years. At each of
these visits, participants will complete some of the same tests and questionnaires from the
screening visit. At the Year 1 visit, participants will also undergo a blood draw. Both
treatment groups will receive two phone calls each year to check on status and use of
oxygen. Participants in both groups will be asked to complete a quality of life
questionnaire by mail at 4 months and 16 months. Participants will also sign a release of
medical records form each year and will have their Medicare claims collected for the time
they are in the study.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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