Trial Outcomes & Findings for Long-term Oxygen Treatment Trial (NCT NCT00692198)

Last Updated: 2017-05-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

738 participants

Primary outcome timeframe

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

Results posted on

2017-05-10

Participant Flow

Participant milestones

Participant milestones
Measure	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.	No Supplemental Oxygen Therapy (No LTOT) 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).
Overall Study STARTED	368	370
Overall Study COMPLETED	368	370
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Long-term Oxygen Treatment Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Supplemental Oxygen Therapy n=368 Participants 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.	No Supplemental Oxygen Therapy n=370 Participants 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).	Total n=738 Participants Total of all reporting groups
Age, Continuous	68.3 years STANDARD_DEVIATION 7.5 • n=5 Participants	69.3 years STANDARD_DEVIATION 7.4 • n=7 Participants	68.8 years STANDARD_DEVIATION 7.5 • n=5 Participants
Sex: Female, Male Female	102 Participants n=5 Participants	94 Participants n=7 Participants	196 Participants n=5 Participants
Sex: Female, Male Male	266 Participants n=5 Participants	276 Participants n=7 Participants	542 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	4 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	358 Participants n=5 Participants	366 Participants n=7 Participants	724 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · African American only	46 Participants n=5 Participants	34 Participants n=7 Participants	80 Participants n=5 Participants
Race/Ethnicity, Customized Race · Caucasian only	299 Participants n=5 Participants	322 Participants n=7 Participants	621 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	23 Participants n=5 Participants	14 Participants n=7 Participants	37 Participants n=5 Participants
Region of Enrollment United States	368 participants n=5 Participants	370 participants n=7 Participants	738 participants n=5 Participants
Medicare coverage	268 Participants n=5 Participants	273 Participants n=7 Participants	541 Participants n=5 Participants
Current tobacco-cigarette smoker	110 Participants n=5 Participants	92 Participants n=7 Participants	202 Participants n=5 Participants
Quality of Well-Being Scale mean daily score	0.56 units on a scale STANDARD_DEVIATION 0.13 • n=5 Participants	0.56 units on a scale STANDARD_DEVIATION 0.13 • n=7 Participants	0.56 units on a scale STANDARD_DEVIATION 0.13 • n=5 Participants
St George's Respiratory Questionnaire total score	49.8 units on a scale STANDARD_DEVIATION 18.7 • n=5 Participants	50.2 units on a scale STANDARD_DEVIATION 17.1 • n=7 Participants	50.0 units on a scale STANDARD_DEVIATION 17.9 • n=5 Participants
Oxygen desaturation type qualifying patient for enrollment Resting desaturation only	73 Participants n=5 Participants	60 Participants n=7 Participants	133 Participants n=5 Participants
Oxygen desaturation type qualifying patient for enrollment Exercise desaturation only	148 Participants n=5 Participants	171 Participants n=7 Participants	319 Participants n=5 Participants
Oxygen desaturation type qualifying patient for enrollment Resting and exercise	147 Participants n=5 Participants	139 Participants n=7 Participants	286 Participants n=5 Participants
SpO2 at rest while breathing ambient air	93.3 SpO2 (percent saturation) STANDARD_DEVIATION 2.1 • n=5 Participants	93.5 SpO2 (percent saturation) STANDARD_DEVIATION 1.9 • n=7 Participants	93.4 SpO2 (percent saturation) STANDARD_DEVIATION 2.0 • n=5 Participants
Nadir SpO2 during 6-min walk while breathing ambient air Less than 86%	86 Participants n=5 Participants	85 Participants n=7 Participants	171 Participants n=5 Participants
Nadir SpO2 during 6-min walk while breathing ambient air 86% through 88%	105 Participants n=5 Participants	103 Participants n=7 Participants	208 Participants n=5 Participants
Nadir SpO2 during 6-min walk while breathing ambient air Greater than 88%	101 Participants n=5 Participants	102 Participants n=7 Participants	203 Participants n=5 Participants
Nadir SpO2 during 6-min walk while breathing ambient air Unknown	76 Participants n=5 Participants	80 Participants n=7 Participants	156 Participants n=5 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Supplemental Oxygen Therapy n=368 Participants 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.	No Supplemental Oxygen Therapy n=370 Participants 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).
Death or Hospitalization, Whichever Occurs First	34.2 Composite events/100 person-years	36.4 Composite events/100 person-years

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Supplemental Oxygen Therapy n=368 Participants 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.	No Supplemental Oxygen Therapy n=370 Participants 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).
Death	5.2 Deaths/100 person-years	5.7 Deaths/100 person-years

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	Supplemental Oxygen Therapy n=368 Participants 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.	No Supplemental Oxygen Therapy n=370 Participants 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).
Health Care Utilization	56.9 Hospitalizations per 100 person-years	56.2 Hospitalizations per 100 person-years

SECONDARY outcome

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

Population: Patients providing at least 1 self-report are included.

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

Outcome measures

Outcome measures
Measure	Supplemental Oxygen Therapy n=368 Participants 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.	No Supplemental Oxygen Therapy n=363 Participants 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).
Adherence	13.6 hours per day of supplemental oxygen Standard Deviation 6.1	1.8 hours per day of supplemental oxygen Standard Deviation 3.9

SECONDARY outcome

Timeframe: Through study completion. Median follow-up was 11.4 months

Rate of all COPD exacerbations

Outcome measures

Outcome measures
Measure	Supplemental Oxygen Therapy n=368 Participants 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.	No Supplemental Oxygen Therapy n=370 Participants 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).
COPD Exacerbation	73.1 COPD exacerbations per 100 person-years	67.7 COPD exacerbations per 100 person-years

SECONDARY outcome

Timeframe: Baseline to 1 year

Population: Participants with both the baseline and 1 year values were included

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.

Outcome measures

Outcome measures
Measure	Supplemental Oxygen Therapy n=341 Participants 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.	No Supplemental Oxygen Therapy n=312 Participants 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).
Preference-weighted Health-related Quality of Life	-0.04 units on a scale Standard Deviation 0.24	-0.04 units on a scale Standard Deviation 0.14

SECONDARY outcome

Timeframe: Baseline to 1 year

Population: Participants with both the baseline and 1 year values are included

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.

Outcome measures

Outcome measures
Measure	Supplemental Oxygen Therapy n=331 Participants 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.	No Supplemental Oxygen Therapy n=299 Participants 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).
Disease-specific Quality of Life	-1.1 units on a scale Standard Deviation 13.5	0.6 units on a scale Standard Deviation 12.7

SECONDARY outcome

Timeframe: Baseline to 1 year

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

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.

Outcome measures

Outcome measures
Measure	Supplemental Oxygen Therapy n=279 Participants 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.	No Supplemental Oxygen Therapy n=241 Participants 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).
General Quality of Life	-0.5 units on a scale Standard Deviation 7.1	-1.0 units on a scale Standard Deviation 7.4

SECONDARY outcome

Timeframe: Baseline to 1 year

Population: Participants with both the baseline and 1 year values are included

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.

Outcome measures

Outcome measures
Measure	Supplemental Oxygen Therapy n=274 Participants 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.	No Supplemental Oxygen Therapy n=240 Participants 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).
Sleep Quality	-0.3 units on a scale Standard Deviation 3.4	0.4 units on a scale Standard Deviation 3.2

SECONDARY outcome

Timeframe: Baseline to 1 year

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

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

Outcome measures

Outcome measures
Measure	Supplemental Oxygen Therapy n=280 Participants 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.	No Supplemental Oxygen Therapy n=243 Participants 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).
Anxiety	-0.1 units on a scale Standard Deviation 3.3	0.3 units on a scale Standard Deviation 3.2

SECONDARY outcome

Timeframe: Baseline to 1 year

Population: Patients with both baseline and 1 year values are included

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

Outcome measures

Outcome measures
Measure	Supplemental Oxygen Therapy n=280 Participants 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.	No Supplemental Oxygen Therapy n=243 Participants 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).
Depression	0.4 units on a scale Standard Deviation 3.0	0.7 units on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: Baseline to 1 year

Population: Participants completing the 1 year saturation assessment are analyzed

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

Outcome measures

Outcome measures
Measure	Supplemental Oxygen Therapy n=322 Participants 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.	No Supplemental Oxygen Therapy n=288 Participants 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).
Development of Severe Resting Desaturation	7 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline to 1 year

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

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

Outcome measures

Outcome measures
Measure	Supplemental Oxygen Therapy n=291 Participants 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.	No Supplemental Oxygen Therapy n=267 Participants 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).
6-minute Walk Distance	-53 feet Standard Deviation 281	-85 feet Standard Deviation 245

SECONDARY outcome

Timeframe: Baseline to 1 year

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

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.

Outcome measures

Outcome measures
Measure	Supplemental Oxygen Therapy n=331 Participants 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.	No Supplemental Oxygen Therapy n=299 Participants 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).
Dyspnea	-1.1 units on a scale Standard Deviation 13.5	0.6 units on a scale Standard Deviation 12.7

Adverse Events

Supplemental Oxygen Therapy

Serious events: 2 serious events

Other events: 30 other events

Deaths: 66 deaths

Patients Crossing Over to Supplemental Oxygen Therapy

Serious events: 0 serious events

Other events: 10 other events

Deaths: 24 deaths

No Supplemental Oxygen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 49 deaths

Serious adverse events

Serious adverse events
Measure	Supplemental Oxygen Therapy n=368 participants at risk 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.	Patients Crossing Over to Supplemental Oxygen Therapy n=125 participants at risk 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	No Supplemental Oxygen n=245 participants at risk Participants in the No supplemental oxygen who did not receive home oxygen during their participation in the trial.
General disorders Event attributed to supplemental oxygen required hospitalization	0.54% 2/368 • Number of events 2 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.	0.00% 0/125 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.	0.00% 0/245 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.

Other adverse events

Other adverse events
Measure	Supplemental Oxygen Therapy n=368 participants at risk 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.	Patients Crossing Over to Supplemental Oxygen Therapy n=125 participants at risk 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	No Supplemental Oxygen n=245 participants at risk Participants in the No supplemental oxygen who did not receive home oxygen during their participation in the trial.
Product Issues Fires related to oxygen use	0.54% 2/368 • Number of events 2 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.	0.00% 0/125 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.	0.00% 0/245 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.
Injury, poisoning and procedural complications Burn from smoking around oxygen equipment	0.54% 2/368 • Number of events 3 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.	0.00% 0/125 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.	0.00% 0/245 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.
Injury, poisoning and procedural complications Burn from using oxygen equipment around open flame	0.00% 0/368 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.	0.80% 1/125 • Number of events 1 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.	0.00% 0/245 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.
Injury, poisoning and procedural complications Burn from liquid oxygen frost	0.82% 3/368 • Number of events 3 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.	0.80% 1/125 • Number of events 1 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.	0.00% 0/245 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.
Ear and labyrinth disorders Nosebleed	1.1% 4/368 • Number of events 4 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.	3.2% 4/125 • Number of events 5 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.	0.00% 0/245 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.
Injury, poisoning and procedural complications Tripping/falling over oxygen equipment not resulting in hospitalization	3.5% 13/368 • Number of events 17 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.	3.2% 4/125 • Number of events 4 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.	0.00% 0/245 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.
Skin and subcutaneous tissue disorders Blisters on ears and ear pain	0.82% 3/368 • Number of events 3 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.	0.00% 0/125 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.	0.00% 0/245 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.
Eye disorders Dry eyes	0.27% 1/368 • Number of events 1 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.	0.00% 0/125 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.	0.00% 0/245 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.
Ear and labyrinth disorders Funny feeling in sinus area	0.27% 1/368 • Number of events 1 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.	0.00% 0/125 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.	0.00% 0/245 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.
Gastrointestinal disorders Increased intestinal gas	0.27% 1/368 • Number of events 1 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.	0.00% 0/125 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.	0.00% 0/245 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.
General disorders Headache	0.54% 2/368 • Number of events 2 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.	0.00% 0/125 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.	0.00% 0/245 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.
General disorders Nausea	0.27% 1/368 • Number of events 1 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.	0.00% 0/125 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.	0.00% 0/245 • Through study completion. Median follow-up of 41.5 months Adverse events reported to be possibly, probably or definitely related to use of supplemental oxygen were tracked. Mortality is reported for those assigned to Supplemental Oxygen, those assigned to No Supplemental Oxygen who crossed over to Supplemental Oxygen at some time during follow-up, and those assigned to No Supplemental Oxygen who never reported using supplemental oxygen, but we do not know whether the patient was using supplemental oxygen when death occurred.

Additional Information

James Tonascia, PhD

Johns Hopkins Bloomberg School of Public Health

Phone: 410-955-8175

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place