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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.
Verified by National Heart, Lung, and Blood Institute (NHLBI), October 2009
First Received: June 4, 2008   Last Updated: November 20, 2009   History of Changes
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Collaborator: Centers for Medicare and Medicaid Services
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00692198
  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 III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Long-term Oxygen Treatment Trial

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 4.5 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 year 3, and once in year 4 ] [ 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 year 3, and once in year 4 ] [ Designated as safety issue: No ]
  • Quality-adjusted survival [ Time Frame: Measured every 4 months for up to 4.5 years ] [ Designated as safety issue: No ]
  • Health care utilization [ Time Frame: Measured every 4 months for up to 4.5 years ] [ Designated as safety issue: No ]
  • Maintenance of nutritional status (e.g., body mass index) [ Time Frame: Measured once per year for up to 4.5 years ] [ Designated as safety issue: No ]
  • General quality of life [ Time Frame: Measured once per year for up to 4.5 years ] [ Designated as safety issue: No ]
  • Sleep quality [ Time Frame: Measured once per year for up to 4.5 years ] [ Designated as safety issue: No ]
  • Depression and anxiety [ Time Frame: Measured once per year for up to 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 up to 4.5 years ] [ Designated as safety issue: No ]
  • 6-minute walk distance [ Time Frame: Measured once per year for up to 4.5 years ] [ Designated as safety issue: No ]
  • Dyspnea [ Time Frame: Measured once per year for up to 4.5 years ] [ Designated as safety issue: No ]
  • COPD exacerbation rate [ Time Frame: Measured every 4 months for up to 4.5 years ] [ Designated as safety issue: No ]
  • Adherence to supplemental oxygen [ Time Frame: Measured every 2 months for up to 4.5 years ] [ Designated as safety issue: No ]
  • Risk of cardiovascular disease [ Time Frame: Measured every 4 months for up to 4.5 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: 1134
Study Start Date: January 2009
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
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.
2: No Intervention
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 4.5 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, a blood draw, and an at-home measurement of blood oxygen level over a 24-hour period. 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 4 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:

  • 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
  • Predicted post-bronchodilator forced expiratory volume in 1 second (FEV1) percent less than or equal to 65% predicted
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00692198

Contacts
Contact: Alice Sternberg, ScM 410-955-3752 asternbe@jhsph.edu

Locations
United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35294
Contact: Debbie Brewton, RN     205-934-5555     dbrewton@uab.edu    
Contact: Allen Cooper, MD     205-934-1339     allenc@uab.edu    
Principal Investigator: Allen Cooper, MD            
Sub-Investigator: Kathleen Harrington, PhD            
Sub-Investigator: Mark Dransfield, MD            
Birmingham VA Medical Center Recruiting
Birmingham, Alabama, United States, 35233
Contact: Janet Bowden     205-933-8101 ext 5550     janet.bowden@va.gov    
Contact: Allen Cooper, MD     205-934-1339     allenc@uab.edu    
Principal Investigator: Allen Cooper, MD            
United States, California
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center Recruiting
Los Angeles, California, United States, 90502
Contact: Peggy Walker     310-222-8200     pwalker@labiomed.org    
Contact: Richard Casaburi, MD, PhD     310-222-8200     casaburi@ucla.edu    
Principal Investigator: Richard Casaburi, MD, PhD            
Sub-Investigator: Janos Porszasz, MD            
Loma Linda VA Medical Center Recruiting
Loma Linda, California, United States, 92357
Contact: Kathleen Ellstrom     909-583-6095     kathleen.ellstrom@va.gov    
Contact: Lennard Specht, MD     909-583-6098     norman.specht@va.gov    
Principal Investigator: Richard Casaburi, MD, PhD            
United States, Colorado
Denver Health and Hospital Authority Recruiting
Denver, Colorado, United States, 80204
Contact: Christine Verano, RN, BSN     720-848-0757     chris.verano@uchsc.edu    
Contact: Richard Albert, MD     303-436-6900     rick.albert@dhha.org    
Principal Investigator: Richard Albert, MD            
Sub-Investigator: Barry Make, MD            
National Jewish Medical and Research Center Recruiting
Denver, Colorado, United States, 80206
Contact: Jennifer Underwood     303-398-1518     underwoodj@njhealth.org    
Contact: Barry Make, MD     303-398-1703     makeb@njhealth.org    
Principal Investigator: Richard Albert, MD            
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Christine Verano     720-848-0757     chris.verano@ucdenver.edu    
Contact: Marvin Schwartz     303-724-4075     marvin.schwartz@ucdenver.edu    
Principal Investigator: Richard Albert, MD            
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Rey Cortes     859-323-6176     rccort2@email.uky.edu    
Contact: Dennis Doherty, MD     859-323-5944     dedohe0@email.uky.edu    
Principal Investigator: Philip Diaz, MD            
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Susan Peterson, RRT     617-732-6272     speterson2@partners.org    
Contact: Anne Fuhlbrigge, MD     617-525-2728     anne.fuhlbrigge@channing.harvard.edu    
Principal Investigator: Anne Fuhlbrigge, MD, MS            
Sub-Investigator: George Washko, MD            
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Catherine Meldrum, RN, BSN     734-647-7840     cathymel@umich.edu    
Contact: Fernando Martinez, MD     734-763-2540     fmartine@umich.edu    
Principal Investigator: Fernando Martinez, MD            
Sub-Investigator: Jeffrey Curtis, MD            
United States, Missouri
Washington University Recruiting
St. Louis, Missouri, United States, 63110
Contact: Jeanne Heaghney, RN     314-747-1610     jheaghne@dom.wustl.edu    
Contact: Roger Yusen, MD     314-454-8764     ryusen@dom.wustl.edu    
Principal Investigator: Roger Yusen, MD, MPH            
Sub-Investigator: Mario Castro, MD, MPH            
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Stephanie Keeting     919-613-6306     stephanie.keeting@duke.edu    
Contact: Neil MacIntyre, MD     919-681-2720     macin001@mc.duke.edu    
Principal Investigator: Neil MacIntyre, MD            
Sub-Investigator: Michael Cicale, MD            
Sub-Investigator: Yuh-Chin Tony Huang, MD, MHS            
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Yvonne Meli     216-445-4215     meliy@ccf.org    
Contact: James Stoller, MD     215-444-1960     stollej@ccf.org    
Principal Investigator: James Stoller, MD, MS            
Sub-Investigator: Kingman Strohl, MD            
Sub-Investigator: Jeffrey Kern, MD            
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Janice Drake     614-366-2287     janice.drake@osumc.edu    
Contact: Philip Diaz, MD     614-293-4925     philip.diaz@osumc.edu    
Principal Investigator: Philip Diaz, MD            
Sub-Investigator: Dennis Doherty, MD            
Sub-Investigator: Ralph Panos, MD            
Cincinnati VA Medical Center Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Laura Lach     513-861-3100 ext 4557     laura.lach@va.gov    
Contact: Ralph Panos, MD     513-861-3100 ext 4500     panosrj@ucmail.uc.edu    
Principal Investigator: Philip Diaz, MD            
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: David Haney     216-844-2381     david.haney@uhhospitals.org    
Contact: Jeffrey Kern, MD     216-844-8101     jeffrey.kern@uhhs.com    
Principal Investigator: James Stoller, MD            
United States, Oregon
Kaiser Foundation Hospitals Recruiting
Portland, Oregon, United States, 97232
Contact: Nancy Siegel, MPH     503-335-6793     nancy.a.siegel@kpchr.org    
Contact: Thomas Stibolt, MD     503-813-3638     tom.stibolt@kp.org    
Principal Investigator: Thomas Stibolt, MD            
Sub-Investigator: Richard Mularski, MD            
Sub-Investigator: Allison Naleway, MD            
United States, Pennsylvania
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Carla Grabianowski, RN, BSN     215-707-1359     carla.grabianowski@tuhs.temple.edu    
Contact: Gerard Criner, MD     215-707-8113     gerard.criner@tuhs.temple.edu    
Principal Investigator: Gerard Criner, MD            
Sub-Investigator: Steven Scharf, MD, PhD            
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Donna Smith, RRT, MS     412-647-9503     smithdd@upmc.edu    
Contact: Frank Sciurba, MD     412-648-6492     sciurbafc@upmc.edu    
Principal Investigator: Frank Sciurba, MD            
Sub-Investigator: Charles Atwood, MD            
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Martin Villegas     801-581-5864     martin.villegas@hsc.utah.edu    
Contact: Richard Kanner, MD     801-581-7806     richard.kanner@hsc.utah.edu    
Principal Investigator: Richard Kanner, MD            
Sub-Investigator: Mary Beth Scholand, MD            
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98101
Contact: Edmunds Udris     206-764-2504     ed.udris@va.gov    
Contact: David Au, MD, MS     206-277-6132     dau@u.washington.edu    
Principal Investigator: David Au, MD, MS            
Sub-Investigator: Bruce Culver, MD            
Puget Sound VA Medical Center Recruiting
Seattle, Washington, United States, 98108
Contact: Edmunds Udris     206-764-2504     ed.udris@va.gov    
Contact: David Au, MD     206-277-6132     dau@u.washington.edu    
Principal Investigator: David Au, MD            
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98101
Contact: Edmunds Udris     206-764-2504     ed.udris@va.gov    
Contact: Randall Curtis, MD, MPH     206-744-3356     jrc@u.washington.edu    
Principal Investigator: David Au, MD, MS            
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: NHLBI ( Antonello Punturieri, MD, PhD )
Study ID Numbers: 583, N01 HR76197
Study First Received: June 4, 2008
Last Updated: November 20, 2009
ClinicalTrials.gov Identifier: NCT00692198     History of Changes
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on February 08, 2010