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Long-term Oxygen Treatment Trial (LOTT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Centers for Medicare and Medicaid Services
Information provided by (Responsible Party):
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00692198
First received: June 4, 2008
Last updated: October 1, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Behavioral: Supplemental oxygen therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of Long-term Oxygen Therapy in Treating People With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Death or hospitalization [ Time Frame: Measured every 4 months for up to 7 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease-specific quality of life [ Time Frame: Measured twice in year 1, twice in year 2, once in each of years 3-6 ] [ Designated as safety issue: No ]
  • Preference-weighted health-related quality of life [ Time Frame: Measured twice in year 1, twice in year 2, once in each of years 3-6 ] [ Designated as safety issue: No ]
  • Quality-adjusted survival [ Time Frame: Measured every 4 months for up to 7 years ] [ Designated as safety issue: No ]
  • Health care utilization [ Time Frame: Measured every 4 months for up to 7 years ] [ Designated as safety issue: No ]
  • Maintenance of nutritional status (e.g., body mass index) [ Time Frame: Measured once per year for up to 7 years ] [ Designated as safety issue: No ]
  • General quality of life [ Time Frame: Measured once per year for up to 7 years ] [ Designated as safety issue: No ]
  • Sleep quality [ Time Frame: Measured once per year for up to 7 years ] [ Designated as safety issue: No ]
  • Depression and anxiety [ Time Frame: Measured once per year for up to 7 years ] [ Designated as safety issue: No ]
  • Onset of severe hypoxemia (defined as room air oxygen saturation less than or equal to 88%) [ Time Frame: Measured once per year for up to 7 years ] [ Designated as safety issue: No ]
  • 6-minute walk distance [ Time Frame: Measured once per year for up to 7 years ] [ Designated as safety issue: No ]
  • Dyspnea [ Time Frame: Measured once per year for up to 7 years ] [ Designated as safety issue: No ]
  • COPD exacerbation rate [ Time Frame: Measured every 4 months for up to 7 years ] [ Designated as safety issue: No ]
  • Adherence to supplemental oxygen [ Time Frame: Measured every 2 months for up to 7 years ] [ Designated as safety issue: No ]
  • Risk of cardiovascular disease [ Time Frame: Measured every 4 months for up to 7 years ] [ Designated as safety issue: No ]
  • Cost effectiveness [ Time Frame: Assessed at end of trial using quality adjusted survival ] [ Designated as safety issue: No ]

Estimated Enrollment: 737
Study Start Date: January 2009
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supplemental oxygen therapy
Participants will receive treatment with supplemental oxygen therapy.
Behavioral: Supplemental oxygen therapy
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.
No Intervention: No supplemental oxygen therapy
Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest).

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 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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00692198

  Show 39 Study Locations
Sponsors and Collaborators
Centers for Medicare and Medicaid Services
Investigators
Study Chair: William C. Bailey, MD University of Alabama at Birmingham Lung Health Center
  More Information

Additional Information:
No publications provided

Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00692198     History of Changes
Other Study ID Numbers: 583, N01HR76197
Study First Received: June 4, 2008
Last Updated: October 1, 2014
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 27, 2014