Long-term Oxygen Treatment Trial
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Supplemental oxygen therapy
Intervention description: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 738.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD

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 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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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