Chronic Obstructive Pulmonary DiseasePhase 3LOTTNCT00692198
Long-term Oxygen Treatment Trial
A Phase 3 study testing Supplemental oxygen therapy in people with Chronic Obstructive Pulmonary Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 39 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Supplemental oxygen therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 738 participants
- Where
- 39 sitesUnited States
- Study dates
- Jan 2009to Aug 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 23Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Maryland
Baltimore, Maryland, 21201
Birmingham VA Medical Center
Birmingham, Alabama, 35233
University of Alabama
Birmingham, Alabama, 35294
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Boston Medical Center
Boston, Massachusetts, 02118
Buffalo VAMC
Buffalo, New York, 14215
University of Illinois at Chicago
Chicago, Illinois, 60612
Cincinnati VA Medical Center
Cincinnati, Ohio, 45220
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ohio State University
Columbus, Ohio, 43210
Geisinger Institute
Danville, Pennsylvania, 17822
Denver Health and Hospital Authority
Denver, Colorado, 80204
National Jewish Medical and Research Center
Denver, Colorado, 80206
City of Hope National Medical Center
Duarte, California, 91010
Duke University
Durham, North Carolina, 27710
Suburban Lung Associates
Elk Grove Village, Illinois, 60007
North Florida/South Georgia VA
Gainseville, Florida, 32608
Institute for Respiratory and Sleep Medicine
Langhorne, Pennsylvania, 19047
Loma Linda VA Medical Center
Loma Linda, California, 92357
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Los Angeles, California, 90502
Louisiana State University Health Sciences Center
New Orleans, Louisiana, 70112
Central Florida Pulmonary Group
Orlando, Florida, 32803
Temple University
Philadelphia, Pennsylvania, 19140
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Kaiser Foundation Hospitals
Portland, Oregon, 97232
Beaumont Hospital
Royal Oak, Michigan, 48073
University of Utah
Salt Lake City, Utah, 84132
University of Texas at San Antonio
San Antonio, Texas, 78249
UCSD Medical Center
San Diego, California, 92103
Harborview Medical Center
Seattle, Washington, 98101
University of Washington
Seattle, Washington, 98101
Puget Sound VA Medical Center
Seattle, Washington, 98108
Washington University
St Louis, Missouri, 63110
Pulmonary Consultants Inc./Christian Hospital
St Louis, Missouri, 63136
Crouse Medical Practice
Syracuse, New York, 13210
Boston VA Medical Center
West Roxbury, Massachusetts, 02132
Weston Florida Cleveland Clinic
Weston, Florida, 33331
Respiratory Specialists
Wyomissing, Pennsylvania, 19610
About this study
Official title: Effectiveness of Long-term Oxygen Therapy in Treating People With Chronic Obstructive Pulmonary Disease With Moderate Desaturation
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Supplemental oxygen therapy
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplemental oxygen therapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Supplemental oxygen therapy | Experimental | Participants will receive treatment with supplemental oxygen therapy. Receives: Drug: Supplemental oxygen therapy |
| No supplemental oxygen therapy | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion. Median follow-up was 18.4 months.
Secondary outcomes (13)
Death
The difference between treatment groups in mortality is assessed with a time-to-event analysis by calculation of the between group hazard ratio for death; 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.
Measured: Through study completion. Median follow-up was 41.5 months.
Health Care Utilization
Health care utilization is measured by the rate of all hospitalizations.
Measured: Through study completion. Median follow-up was 18.4 months.
Adherence
Adherence is measured by self-reported hours of home oxygen per day
Measured: Through study completion. Median follow-up was 18.4 months.
COPD Exacerbation
Rate of all COPD exacerbations
Measured: Through study completion. Median follow-up was 11.4 months
Preference-weighted Health-related Quality of Life
Preference-weighted health-related quality of life is measured by change in the Quality of Well-being Scale total daily score, follow-up value minus baseline value. The total daily score ranges from 0 to 1 with higher score indicating more better quality of life. Death is scored 0. Greater change, follow-up minus baseline, indicates improvement in quality of life compared to baseline. Change scores may range from -1 to +1.
Measured: Baseline to 1 year
Disease-specific Quality of Life
Disease-specific quality of life is measured by the change in the St George's Respiratory Questionnaire total score, follow-up value minus baseline value. The total score ranges from 0 to 100 with lower score indicating fewer respiratory symptoms. Change in score, follow-up minus baseline may range from -100 to +100, with lower values indicating improvement in disease-specific quality of life.
Measured: Baseline to 1 year
General Quality of Life
General quality of life is measured by the change in the physical component summary subscale of the SF-36 quality of life questionnaire, follow-up value minus baseline value. The physical component summary subscale score ranges from 0 to 100 with higher values indicating better physical functioning. The change in score, follow-up minus baseline value, ranges from -100 to +100 with higher values indicating improvement in physical functioning.
Measured: Baseline to 1 year
Sleep Quality
Sleep quality is measured by the change in the Pittsburgh Sleep Quality Index total score, follow-up value minus baseline value. The Pittsburgh Sleep Quality Index total score ranges from 0 to 21 with higher values indicating worse sleep quality. The change in score, follow-up minus baseline value, ranges from -21 to +21 with higher values indicating worsening in sleep quality.
Measured: Baseline to 1 year
Anxiety
Anxiety is measured by the change in the Hospital Anxiety and Depression Scale (HADS) anxiety score, follow-up value minus baseline value. The HADS anxiety score ranges from 0 to 21 with higher values indicating greater anxiety. The change in score, follow-up minus baseline value, ranges from -21 to +21 with higher values indicating increase in anxiety
Measured: Baseline to 1 year
Depression
Depression is measured by the change in the Hospital Anxiety and Depression Scale (HADS) depression score, follow-up value minus baseline value. The HADS depression score ranges from 0 to 21 with higher values indicating greater depression. The change in score, follow-up minus baseline value, ranges from -21 to +21 with higher values indicating increase in depression
Measured: Baseline to 1 year
Development of Severe Resting Desaturation
Severe resting desaturation is defined as resting room air SpO2 <=88%
Measured: Baseline to 1 year
6-minute Walk Distance
Change in distance walked during 6-minute walk test, follow-up value minus baseline value (feet)
Measured: Baseline to 1 year
Dyspnea
Change in dyspnea is measured by change in the St George's Respiratory Questionnaire (SGRQ) total score, follow-up value minus baseline value. The SGRQ total score ranges from 0 to 100, with higher values indicating worse dyspnea. The change in score, follow-up value minus baseline value, ranges from -100 to +100, with higher values indicating increase in dyspnea.
Measured: Baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startJan 2009
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 738 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Centers for Medicare and Medicaid Services
- Responsible party
- Sponsor
- Investigators
- William C. Bailey, MD, Study chair, University of Alabama at Birmingham Lung Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692198
- Sponsor's protocol ID
- 583
- Other IDs
- N01HR76197-12-0-3
- Acronym
- LOTT
- Status last verified
- Nov 2016
- First submitted
- 4 Jun 2008
- Last updated
- 10 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 27783918Moy 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.
PubMed 30803886Yusen 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.
PubMed 29087741Stoller 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.
PubMed 26653189
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Long-term Oxygen Therapy in Treating People With Chronic Obstructive Pulmonary Disease With Moderate Desaturation
- ClinicalTrials.gov ID
- NCT00692198
- Acronym / sponsor ID
- LOTT / 583
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 738 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Collaborators
- Centers for Medicare and Medicaid Services
- Study start
- Jan 2009
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 6 Jun 2008 (estimated)
- Results
- Posted 4 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplemental oxygen therapy | Experimental | Drug: Supplemental oxygen therapyParticipants will receive treatment with supplemental oxygen therapy. |
| No supplemental oxygen therapy | 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). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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:
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supplemental oxygen therapyOxygen 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. | Drug | Supplemental oxygen therapy |
Primary outcome
Death or Hospitalization, Whichever Occurs First
Time frame: Through study completion. Median follow-up was 18.4 months.
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.
13 secondary outcomes
Death
Time frame: Through study completion. Median follow-up was 41.5 months.
Health Care Utilization
Time frame: Through study completion. Median follow-up was 18.4 months.
Adherence
Time frame: Through study completion. Median follow-up was 18.4 months.
COPD Exacerbation
Time frame: Through study completion. Median follow-up was 11.4 months
Preference-weighted Health-related Quality of Life
Time frame: Baseline to 1 year
Disease-specific Quality of Life
Time frame: Baseline to 1 year
General Quality of Life
Time frame: Baseline to 1 year
Sleep Quality
Time frame: Baseline to 1 year
Anxiety
Time frame: Baseline to 1 year
Depression
Time frame: Baseline to 1 year
Development of Severe Resting Desaturation
Time frame: Baseline to 1 year
6-minute Walk Distance
Time frame: Baseline to 1 year
Dyspnea
Time frame: Baseline to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27783918Long-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.
- Derived from this study: PubMed 30803886Moy 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.
- Derived from this study: PubMed 29087741Yusen 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.
- Derived from this study: PubMed 26653189Stoller 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.
- Click here for more information about the Long-term Oxygen Treatment TrialLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William C. Bailey, MD study chair
University of Alabama at Birmingham Lung Health Center
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Supplemental oxygen therapy in people with Chronic Obstructive Pulmonary Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 39 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death or Hospitalization, Whichever Occurs First (time frame: Through study completion. Median follow-up was 18.4 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00692198, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2017.