Status:
COMPLETED
Long-term Oxygen Treatment Trial
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsors:
Centers for Medicare and Medicaid Services
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
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 difficult...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Age at least 40 years
- COPD
- Dyspnea, determined by Modified Medical Research Council (MMRC) scale of at least 1
- Dyspnea and lung disease process dominated by COPD in judgment of the study physician
- Participant must meet one of the following:
- Post-bronchodilator forced expiratory volume in 1 second (FEV1) percent less than or equal to 70% predicted
- Post-bronchodilator forced expiratory volume in 1 second (FEV1) percent \>70% predicted and LOTT study physician determines that there is radiologic evidence of emphysema
- Post-bronchodilator FEV1/forced vital capacity (FVC) less then 0.70
- Participant must meet either of the following oxygen saturation criteria:
- Oxygen saturation of at least 89% and no greater than 93% after sitting quietly on room air, without hyperventilation and without pursed lips breathing during oximetry
- Resting oxygen saturation 94% or greater and desaturation during exercise defined as saturation below 90% for at least 10 seconds during the 6 minute walk test
- If participant is on supplemental oxygen at the start of screening, all of the following must be met prior to randomization:
- Participant agrees to stop using oxygen if randomized to no oxygen
- Participant's physician agrees in writing to rescind order for oxygen if participant is randomized to no oxygen
- Participant must report not using oxygen on the day of randomization and must report not using oxygen for the 4 calendar days prior to randomization
- Satisfactory resolution of logistics of continuation with same oxygen company with waiver of cost sharing obligations or switch to new company that will waive cost sharing obligations if participant is randomized to oxygen
- At least 10 pack-years of tobacco cigarette smoking before study entry
- Agreement not to smoke while using supplemental oxygen
- Medicare beneficiary with both Part A and Part B coverage or insurance OR personally willing to cover costs typically covered by Medicare
- Approval of study physician for randomization to either treatment group
- Completion of all required prerandomization assessments within 60 days of initiating study entry
- Randomization within 60 days of initiating eligibility evaluation
- Consent
Exclusion
- Less than 30 days post treatment for acute exacerbation of COPD as of initiating eligibility evaluation (less than 30 days from last dose of antibiotics or since a new or increased dose of systemic corticosteroids was initiated); chronic use of systemic corticosteroids while health is stable is not exclusionary
- COPD exacerbation requiring antibiotics, new or increased dose of systemic corticosteroids, or oxygen treatment after screening starts and prior to randomization (chronic use of corticosteroids while health is stable is not exclusionary)
- Less than 30 days post discharge from an acute care hospital after acute care hospitalization for COPD or other condition, as of initiating eligibility evaluation (participant may be in a rehab hospital at time of screening)
- New prescription of supplemental oxygen after screening starts and before randomization
- Thoracotomy, sternotomy, major cardiopulmonary intervention (e.g., lung resection, open heart surgery, etc.), or other procedure in the 6 months before study entry likely to cause instability of pulmonary status
- Non-COPD lung disease that affects oxygenation or survival
- Epworth Sleepiness Scale score greater than 15
- Desaturation below 80% for at least 1 minute during the 6-minute walk test
- Disease or condition expected to cause death, inability to perform procedures for the trial, or inability to comply with therapy within 6 months of random assignment, as judged by the study physician
- Participation in another intervention study
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
738 Patients enrolled
Trial Details
Trial ID
NCT00692198
Start Date
January 1 2009
End Date
August 1 2015
Last Update
May 10 2017
Active Locations (39)
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1
Birmingham VA Medical Center
Birmingham, Alabama, United States, 35233
2
University of Alabama
Birmingham, Alabama, United States, 35294
3
City of Hope National Medical Center
Duarte, California, United States, 91010
4
Loma Linda VA Medical Center
Loma Linda, California, United States, 92357