Long-term Oxygen Treatment Trial | NCT00692198

ID	Type	Description	Link
N01HR76197-12-0-3	U.S. NIH Grant/Contract		View source

Status Module

Name	Class
Centers for Medicare and Medicaid Services	FED

Description Module

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.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Supplemental oxygen therapy	Experimental	Participants will receive treatment with supplemental oxygen therapy.	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).

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Supplemental oxygen therapy	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.	Through study completion. Median follow-up was 41.5 months.

Eligibility Module

Eligibility 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

Name	Affiliation	Role
William C. Bailey, MD	University of Alabama at Birmingham Lung Health Center	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Birmingham VA Medical Center		Birmingham	Alabama	35233	United States
University of Alabama

PubMed Identifier	Type	Citation	Retractions
27783918	Result	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.
30803886

Label	URL
Click here for more information about the Long-term Oxygen Treatment Trial	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Supplemental Oxygen Therapy (LTOT)	Participants will receive treatment with supplemental oxygen therapy. 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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Supplemental Oxygen Therapy	Participants will receive treatment with supplemental oxygen therapy. 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.
BG001	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).
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00068.3± 7.5 BG00169.3± 7.4 BG00268.8± 7.5

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000102 BG00194 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00010 BG0014 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Race

Title	Measurements
African American only	BG00046 BG00134 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000368 BG001370 BG002

Medicare coverage

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG000268 BG001273 BG002

Current tobacco-cigarette smoker

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG000110 BG00192 BG002

Quality of Well-Being Scale mean daily score

The Quality of Well Being questionnaire measures health related quality of life and is comprised of of 79 self reported items. The total daily score ranges from 0 to 1, with higher score indicating higher quality of life.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG0000.56± 0.13 BG001

St George's Respiratory Questionnaire total score

The St George's Respiratory Questionnaire measures the impact of chest disease on daily life and well-being and is comprised of 51 items. The total score ranges from 0 to 100 with lower scores indicating better functioning.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG00049.8± 18.7 BG001

Oxygen desaturation type qualifying patient for enrollment

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Resting desaturation only	BG00073 BG00160 BG002

SpO2 at rest while breathing ambient air

Mean

Standard Deviation

SpO2 (percent saturation)

Title

Denominators

Categories

Title	Measurements
	BG00093.3± 2.1 BG00193.5± 1.9 BG002

Nadir SpO2 during 6-min walk while breathing ambient air

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Less than 86%	BG00086 BG00185 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Posted

Number

Composite events/100 person-years

Through study completion. Median follow-up was 18.4 months.

ID	Title	Description
OG000	Supplemental Oxygen Therapy	Participants will receive treatment with supplemental oxygen therapy. 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.
OG001	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) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).

Units	Counts
Participants	OG000368 OG001370

Title

Denominators

Categories

Title	Measurements
	OG00034.2 OG00136.4

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		0.52		Hazard Ratio (HR)	0.94			2-Sided	95	0.79	1.12					Superiority or Other

Secondary

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.

Posted

Number

Deaths/100 person-years

Through study completion. Median follow-up was 41.5 months.

ID	Title	Description
OG000	Supplemental Oxygen Therapy	Participants will receive treatment with supplemental oxygen therapy. 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.
OG001	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) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).

Secondary

Health Care Utilization

Health care utilization is measured by the rate of all hospitalizations.

Posted

Number

Hospitalizations per 100 person-years

Through study completion. Median follow-up was 18.4 months.

ID	Title	Description
OG000	Supplemental Oxygen Therapy	Participants will receive treatment with supplemental oxygen therapy. 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.
OG001	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) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).

Units

Secondary

Adherence

Adherence is measured by self-reported hours of home oxygen per day

Patients providing at least 1 self-report are included.

Posted

Mean

Standard Deviation

hours per day of supplemental oxygen

Through study completion. Median follow-up was 18.4 months.

ID	Title	Description
OG000	Supplemental Oxygen Therapy	Participants will receive treatment with supplemental oxygen therapy. 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.
OG001	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) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).

Secondary

COPD Exacerbation

Rate of all COPD exacerbations

Posted

Number

COPD exacerbations per 100 person-years

Through study completion. Median follow-up was 11.4 months

ID	Title	Description
OG000	Supplemental Oxygen Therapy	Participants will receive treatment with supplemental oxygen therapy. 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.
OG001	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) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).

Units	Counts

Secondary

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.

Participants with both the baseline and 1 year values were included

Posted

Mean

Standard Deviation

units on a scale

Baseline to 1 year

ID	Title	Description
OG000	Supplemental Oxygen Therapy	Participants will receive treatment with supplemental oxygen therapy. 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.
OG001	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) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).

Secondary

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.

Participants with both the baseline and 1 year values are included

Posted

Mean

Standard Deviation

units on a scale

Baseline to 1 year

ID	Title	Description
OG000	Supplemental Oxygen Therapy	Participants will receive treatment with supplemental oxygen therapy. 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.
OG001	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) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).

Secondary

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.

Participants with both the baseline and 1 year values are included; the SF-36 was administered at a subset of clinics

Posted

Mean

Standard Deviation

units on a scale

Baseline to 1 year

ID	Title	Description
OG000	Supplemental Oxygen Therapy	Participants will receive treatment with supplemental oxygen therapy. 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.
OG001	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) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).

Secondary

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.

Participants with both the baseline and 1 year values are included

Posted

Mean

Standard Deviation

units on a scale

Baseline to 1 year

ID	Title	Description
OG000	Supplemental Oxygen Therapy	Participants will receive treatment with supplemental oxygen therapy. 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.
OG001	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) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).

Secondary

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

Patients with both the baseline and 1 year values are included; a subset of clinics administered the HADS questionnaire.

Posted

Mean

Standard Deviation

units on a scale

Baseline to 1 year

ID	Title	Description
OG000	Supplemental Oxygen Therapy	Participants will receive treatment with supplemental oxygen therapy. 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.
OG001	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) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).

Secondary

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

Patients with both baseline and 1 year values are included

Posted

Mean

Standard Deviation

units on a scale

Baseline to 1 year

ID	Title	Description
OG000	Supplemental Oxygen Therapy	Participants will receive treatment with supplemental oxygen therapy. 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.
OG001	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) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).

Secondary

Development of Severe Resting Desaturation

Severe resting desaturation is defined as resting room air SpO2 <=88%

Participants completing the 1 year saturation assessment are analyzed

Posted

Count of Participants

Participants

Baseline to 1 year

ID	Title	Description
OG000	Supplemental Oxygen Therapy	Participants will receive treatment with supplemental oxygen therapy. 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.
OG001	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) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).

Secondary

6-minute Walk Distance

Change in distance walked during 6-minute walk test, follow-up value minus baseline value (feet)

Change in 6 minute walk distance from baseline to 1 year is analyzed for patients with both baseline and 1 year values

Posted

Mean

Standard Deviation

feet

Baseline to 1 year

ID	Title	Description
OG000	Supplemental Oxygen Therapy	Participants will receive treatment with supplemental oxygen therapy. 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.
OG001	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) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).

Secondary

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.

Patients with both the baseline and 1 year SGRQ total score are included

Posted

Mean

Standard Deviation

units on a scale

Baseline to 1 year

ID	Title	Description
OG000	Supplemental Oxygen Therapy	Participants will receive treatment with supplemental oxygen therapy. 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.
OG001	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) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Supplemental Oxygen Therapy	Participants will receive treatment with supplemental oxygen therapy. 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.	66	368	2	368	30	368
EG001	Patients Crossing Over to Supplemental Oxygen Therapy	Participants in the No supplemental oxygen therapy group who receive supplemental oxygen therapy during their participation in the trial due to prescription of supplemental oxygen outside the trial or development of severe resting or exercise hypoxemia	24	125	0	125	10	125
EG002	No Supplemental Oxygen	Participants in the No supplemental oxygen who did not receive home oxygen during their participation in the trial.	49	245	0	245	0	245

Other Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
Fires related to oxygen use	Product Issues	Non-systematic Assessment	Home fire related to oxygen use	EG0002 events2 affected368 at risk EG0010 events0 affected125 at risk EG0020 events0 affected245 at risk
Burn from smoking around oxygen equipment	Injury, poisoning and procedural complications	Non-systematic Assessment		EG0003 events2 affected368 at risk EG0010 events0 affected125 at risk EG0020 events0 affected245 at risk
Burn from using oxygen equipment around open flame	Injury, poisoning and procedural complications	Non-systematic Assessment		EG0000 events0 affected368 at risk EG0011 events1 affected125 at risk EG0020 events0 affected245 at risk
Burn from liquid oxygen frost	Injury, poisoning and procedural complications	Non-systematic Assessment		EG0003 events3 affected368 at risk EG0011 events1 affected125 at risk EG0020 events0 affected245 at risk
Nosebleed	Ear and labyrinth disorders	Non-systematic Assessment		EG0004 events4 affected368 at risk EG0015 events4 affected125 at risk EG0020 events0 affected245 at risk
Tripping/falling over oxygen equipment not resulting in hospitalization	Injury, poisoning and procedural complications	Non-systematic Assessment		EG00017 events13 affected368 at risk EG0014 events4 affected125 at risk EG0020 events0 affected245 at risk
Blisters on ears and ear pain	Skin and subcutaneous tissue disorders	Non-systematic Assessment		EG0003 events3 affected368 at risk EG0010 events0 affected125 at risk EG0020 events0 affected245 at risk
Dry eyes	Eye disorders	Non-systematic Assessment		EG0001 events1 affected368 at risk EG0010 events0 affected125 at risk EG0020 events0 affected245 at risk
Funny feeling in sinus area	Ear and labyrinth disorders	Non-systematic Assessment		EG0001 events1 affected368 at risk EG0010 events0 affected125 at risk EG0020 events0 affected245 at risk
Increased intestinal gas	Gastrointestinal disorders	Non-systematic Assessment		EG0001 events1 affected368 at risk EG0010 events0 affected125 at risk EG0020 events0 affected245 at risk
Headache	General disorders	Non-systematic Assessment		EG0002 events2 affected368 at risk EG0010 events0 affected125 at risk EG0020 events0 affected245 at risk
Nausea	General disorders	Non-systematic Assessment		EG0001 events1 affected368 at risk EG0010 events0 affected125 at risk EG0020 events0 affected245 at risk

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D018011	Chalcogens
D004602	Elements
D007287	Inorganic Chemicals
D005740	Gases