Long-term Oxygen Treatment Trial
LOTT
Effectiveness of Long-term Oxygen Therapy in Treating People With Chronic Obstructive Pulmonary Disease With Moderate Desaturation
2 other identifiers
interventional
738
1 country
39
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 chronic-obstructive-pulmonary-disease
Started Jan 2009
Longer than P75 for phase_3 chronic-obstructive-pulmonary-disease
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2008
CompletedFirst Posted
Study publicly available on registry
June 6, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedResults Posted
Study results publicly available
April 4, 2017
CompletedMay 10, 2017
November 1, 2016
6.6 years
June 4, 2008
November 10, 2016
April 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Death or Hospitalization, Whichever Occurs First
The primary outcome event is death or hospitalization, whichever occurs first. The difference between treatment groups on the primary outcome was assessed with a time-to-event analysis by calculation of the between group hazard ratio for the primary composite outcome; the statistical significance of the hazard ratio was determined from the log rank test. The uncertainty in the hazard ratio is expressed in the 95% confidence interval on the hazard ratio.
Through study completion. Median follow-up was 18.4 months.
Secondary Outcomes (13)
Death
Through study completion. Median follow-up was 41.5 months.
Health Care Utilization
Through study completion. Median follow-up was 18.4 months.
Adherence
Through study completion. Median follow-up was 18.4 months.
COPD Exacerbation
Through study completion. Median follow-up was 11.4 months
Preference-weighted Health-related Quality of Life
Baseline to 1 year
- +8 more secondary outcomes
Study Arms (2)
Supplemental oxygen therapy
EXPERIMENTALParticipants will receive treatment with supplemental oxygen therapy.
No supplemental oxygen therapy
NO INTERVENTIONParticipants 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).
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
- +8 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Birmingham VA Medical Center
Birmingham, Alabama, 35233, United States
University of Alabama
Birmingham, Alabama, 35294, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
Loma Linda VA Medical Center
Loma Linda, California, 92357, United States
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Los Angeles, California, 90502, United States
UCSD Medical Center
San Diego, California, 92103, United States
Denver Health and Hospital Authority
Denver, Colorado, 80204, United States
National Jewish Medical and Research Center
Denver, Colorado, 80206, United States
North Florida/South Georgia VA
Gainseville, Florida, 32608, United States
Central Florida Pulmonary Group
Orlando, Florida, 32803, United States
Weston Florida Cleveland Clinic
Weston, Florida, 33331, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Suburban Lung Associates
Elk Grove Village, Illinois, 60007, United States
Louisiana State University Health Sciences Center
New Orleans, Louisiana, 70112, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Boston VA Medical Center
West Roxbury, Massachusetts, 02132, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Washington University
St Louis, Missouri, 63110, United States
Pulmonary Consultants Inc./Christian Hospital
St Louis, Missouri, 63136, United States
Buffalo VAMC
Buffalo, New York, 14215, United States
Crouse Medical Practice
Syracuse, New York, 13210, United States
Duke University
Durham, North Carolina, 27710, United States
Cincinnati VA Medical Center
Cincinnati, Ohio, 45220, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43210, United States
Kaiser Foundation Hospitals
Portland, Oregon, 97232, United States
Geisinger Institute
Danville, Pennsylvania, 17822, United States
Institute for Respiratory and Sleep Medicine
Langhorne, Pennsylvania, 19047, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Respiratory Specialists
Wyomissing, Pennsylvania, 19610, United States
University of Texas at San Antonio
San Antonio, Texas, 78249, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Harborview Medical Center
Seattle, Washington, 98101, United States
University of Washington
Seattle, Washington, 98101, United States
Puget Sound VA Medical Center
Seattle, Washington, 98108, United States
Related Publications (4)
Long-Term Oxygen Treatment Trial Research Group; Albert RK, Au DH, Blackford AL, Casaburi R, Cooper JA Jr, Criner GJ, Diaz P, Fuhlbrigge AL, Gay SE, Kanner RE, MacIntyre N, Martinez FJ, Panos RJ, Piantadosi S, Sciurba F, Shade D, Stibolt T, Stoller JK, Wise R, Yusen RD, Tonascia J, Sternberg AL, Bailey W. A Randomized Trial of Long-Term Oxygen for COPD with Moderate Desaturation. N Engl J Med. 2016 Oct 27;375(17):1617-1627. doi: 10.1056/NEJMoa1604344.
PMID: 27783918RESULTMoy ML, Harrington KF, Sternberg AL, Krishnan JA, Albert RK, Au DH, Casaburi R, Criner GJ, Diaz P, Kanner RE, Panos RJ, Stibolt T, Stoller JK, Tonascia J, Yusen RD, Tan AM, Fuhlbrigge AL; LOTT Research Group. Characteristics at the time of oxygen initiation associated with its adherence: Findings from the COPD Long-term Oxygen Treatment Trial. Respir Med. 2019 Mar;149:52-58. doi: 10.1016/j.rmed.2019.02.004. Epub 2019 Feb 13.
PMID: 30803886DERIVEDYusen RD, Criner GJ, Sternberg AL, Au DH, Fuhlbrigge AL, Albert RK, Casaburi R, Stoller JK, Harrington KF, Cooper JAD Jr, Diaz P, Gay S, Kanner R, MacIntyre N, Martinez FJ, Piantadosi S, Sciurba F, Shade D, Stibolt T, Tonascia J, Wise R, Bailey WC; LOTT Research Group *; LOTT Research Group. The Long-Term Oxygen Treatment Trial for Chronic Obstructive Pulmonary Disease: Rationale, Design, and Lessons Learned. Ann Am Thorac Soc. 2018 Jan;15(1):89-101. doi: 10.1513/AnnalsATS.201705-374SD.
PMID: 29087741DERIVEDStoller JK, Aboussouan LS, Kanner RE, Wilson LA, Diaz P, Wise R; LOTT Research Group. Characteristics of Alpha-1 Antitrypsin-Deficient Individuals in the Long-term Oxygen Treatment Trial and Comparison with Other Subjects with Chronic Obstructive Pulmonary Disease. Ann Am Thorac Soc. 2015 Dec;12(12):1796-804. doi: 10.1513/AnnalsATS.201506-389OC.
PMID: 26653189DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- James Tonascia, PhD
- Organization
- Johns Hopkins Bloomberg School of Public Health
Study Officials
- STUDY CHAIR
William C. Bailey, MD
University of Alabama at Birmingham Lung Health Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2008
First Posted
June 6, 2008
Study Start
January 1, 2009
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
May 10, 2017
Results First Posted
April 4, 2017
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will share
Datasets and associated documentation will be deposited with the National Heart, Lung, and Blood Institute Biologic Specimen and Data Repository Information Coordinating Center (NHLBI BioLINCC) repository once the contract ends, currently scheduled for May 2017. Data will be deidentified per BioLINCC requirements; datasets will include baseline and follow-up data collected during the trial. The BioLINCC Repository website includes instructions regarding accessing data on deposit in their repository.