Trial record 1 of 57 for:    Long Term Oxygen Treatment trial
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Effectiveness of Long-term Oxygen Therapy in Treating People With Chronic Obstructive Pulmonary Disease (The Long-term Oxygen Treatment Trial [LOTT])

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by National Heart, Lung, and Blood Institute (NHLBI)
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: July 18, 2013
Last verified: July 2013

June 4, 2008
July 18, 2013
January 2009
December 2015   (final data collection date for primary outcome measure)
Death or hospitalization [ Time Frame: Measured every 4 months for up to 7 years ] [ Designated as safety issue: No ]
Survival [ Time Frame: Measured every 4 months for 4.5 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00692198 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Disease impact (e.g., disease-specific quality of life, dyspnea, 6-minute walk distance, exacerbation rate) [ Time Frame: Measured once per year for 4.5 years ] [ Designated as safety issue: No ]
  • Preference-weighted health-related quality of life [ Time Frame: Measured once per year for 4.5 years ] [ Designated as safety issue: No ]
  • Quality-adjusted survival [ Time Frame: Measured every 4 months for 4.5 years ] [ Designated as safety issue: No ]
  • Health care utilization [ Time Frame: Measured every 4 months for 4.5 years ] [ Designated as safety issue: No ]
  • Maintenance of nutritional status (e.g., body mass index) [ Time Frame: Measured once per year for 4.5 years ] [ Designated as safety issue: No ]
  • General quality of life [ Time Frame: Measured once per year for 4.5 years ] [ Designated as safety issue: No ]
  • Sleep quality [ Time Frame: Measured once per year for 4.5 years ] [ Designated as safety issue: No ]
  • Depression and anxiety [ Time Frame: Measured once per year for 4.5 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 4.5 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effectiveness of Long-term Oxygen Therapy in Treating People With Chronic Obstructive Pulmonary Disease (The Long-term Oxygen Treatment Trial [LOTT])
Long-term Oxygen Treatment Trial

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
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.
  • Experimental: 1
    Participants will receive treatment with supplemental oxygen therapy.
    Intervention: Behavioral: Supplemental oxygen therapy
  • No Intervention: 2
    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).
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
737
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact: Alice Sternberg, ScM 410-955-3752 asternbe@jhsph.edu
United States
 
NCT00692198
583, N01 HR76197
Yes
National Heart, Lung, and Blood Institute (NHLBI)
National Heart, Lung, and Blood Institute (NHLBI)
Centers for Medicare and Medicaid Services
Study Chair: William C. Bailey, MD University of Alabama at Birmingham Lung Health Center
National Heart, Lung, and Blood Institute (NHLBI)
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP