LOTT: Long-term Oxygen Treatment Trial

• Sponsor: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00692198
• Collaborator: Centers for Medicare and Medicaid Services (U.S. Fed)
• Enrollment: 738
• Locations: 39
• Arms: 2
• Duration (Months): 78.9
• Patients Per Site: 18.9
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

Chronic obstructive pulmonary disease (COPD) is a serious respiratory disease in which the airways in the lungs are partially blocked, resulting in symptoms of chest tightness, coughing, and difficulty breathing. Currently, there are many available treatments for managing COPD symptoms and improving quality of life, including medications, lifestyle changes, oxygen therapy, and pulmonary rehabilitation. For people with severe COPD that is characterized by very low blood oxygen levels at rest, long term oxygen therapy can help to prolong life and promote feelings of well-being. However, the effectiveness of supplemental oxygen therapy for people with COPD that is characterized by only moderately low blood oxygen levels at rest or normal blood oxygen at rest and desaturation on exercise is not known. This study will evaluate the effectiveness of supplemental oxygen therapy in treating people with COPD who have moderately low blood oxygen levels at rest or who have normal blood oxygen levels at rest, but have low or very low blood oxygen levels during exercise.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: Supplemental oxygen therapy	Phase 3

Detailed Description

COPD is the fourth leading cause of death in the United States, with more than 12 million people currently diagnosed with the disease. Risk factors for COPD include smoking, environmental exposure to lung irritants, and genetic predisposition. People with COPD often experience symptoms of chronic cough, shortness of breath, excess mucus production, and wheezing. In COPD, the airways in the lungs are chronically obstructed, and if left untreated, this obstruction can cause significant damage to the lungs and lasting disability. The quality of life of a person with COPD decreases as the disease progresses, making treating and managing COPD in the moderate stages important. Long-term oxygen therapy has been shown to help people with severe COPD that is characterized by very low blood oxygen levels at rest to live longer and healthier lives. This study will determine whether supplemental oxygen therapy is helpful for people with COPD that is characterized by moderately low blood oxygen levels at rest or normal oxygen levels at rest and low or very low levels during exercise.

Participation in this study will last at least one year and up to 7 years. Potential participants will first undergo a screening visit that will include questionnaires, a breathing test, measurements of resting and walking blood oxygen levels, a brief physical exam, and a blood draw. Eligible participants will then return for a second screening visit, during which they will complete more questionnaires. At the end of the second visit, eligible participants will be assigned randomly to supplemental oxygen therapy or no oxygen therapy.

Participants assigned to supplemental oxygen therapy will receive stationary and portable oxygen systems. Shortly after receiving the portable oxygen system, participants will return for a 1-hour visit to determine how much oxygen to use while walking and to learn how to use the equipment. Participants who have low blood oxygen levels during rest will be instructed to use supplemental oxygen 24 hours per day. Patients with normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise will be instructed to use it during physical activity and sleep. Throughout the treatment period, participants will be asked to keep records of the number of oxygen tanks emptied or pounds of oxygen delivered, meter readings, and changes in equipment. Study officials will contact participants weekly for the first month, monthly for the next 5 months, and then every 2 months until the Year 1 study visit. Participants will also complete a form about their oxygen equipment and usage every 2 months. Participants assigned to receive no oxygen treatment will be contacted 1 week after study group assignment for a check-up.

All participants will return for study visits once a year for up to 7 years. At each of these visits, participants will complete some of the same tests and questionnaires from the screening visit. At the Year 1 visit, participants will also undergo a blood draw. Both treatment groups will receive two phone calls each year to check on status and use of oxygen. Participants in both groups will be asked to complete a quality of life questionnaire by mail at 4 months and 16 months. Participants will also sign a release of medical records form each year and will have their Medicare claims collected for the time they are in the study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 738 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effectiveness of Long-term Oxygen Therapy in Treating People With Chronic Obstructive Pulmonary Disease With Moderate Desaturation
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Supplemental oxygen therapy Participants will receive treatment with supplemental oxygen therapy.	Drug: 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 Intervention: 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).

Outcome Measures

Primary Outcome Measures

1. Death or Hospitalization, Whichever Occurs First [Through study completion. Median follow-up was 18.4 months.]

   The primary outcome event is death or hospitalization, whichever occurs first. The difference between treatment groups on the primary outcome was assessed with a time-to-event analysis by calculation of the between group hazard ratio for the primary composite outcome; the statistical significance of the hazard ratio was determined from the log rank test. The uncertainty in the hazard ratio is expressed in the 95% confidence interval on the hazard ratio.

Secondary Outcome Measures

1. Death [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.

2. Health Care Utilization [Through study completion. Median follow-up was 18.4 months.]

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

3. Adherence [Through study completion. Median follow-up was 18.4 months.]

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

4. COPD Exacerbation [Through study completion. Median follow-up was 11.4 months]

   Rate of all COPD exacerbations

5. Preference-weighted Health-related Quality of Life [Baseline to 1 year]

   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.

6. Disease-specific Quality of Life [Baseline to 1 year]

   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.

7. General Quality of Life [Baseline to 1 year]

   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.

8. Sleep Quality [Baseline to 1 year]

   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.

9. Anxiety [Baseline to 1 year]

   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

10. Depression [Baseline to 1 year]

    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

11. Development of Severe Resting Desaturation [Baseline to 1 year]

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

12. 6-minute Walk Distance [Baseline to 1 year]

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

13. Dyspnea [Baseline to 1 year]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Birmingham VA Medical Center	Birmingham	Alabama	United States	35233
2	University of Alabama	Birmingham	Alabama	United States	35294
3	City of Hope National Medical Center	Duarte	California	United States	91010
4	Loma Linda VA Medical Center	Loma Linda	California	United States	92357
5	Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center	Los Angeles	California	United States	90502
6	UCSD Medical Center	San Diego	California	United States	92103
7	Denver Health and Hospital Authority	Denver	Colorado	United States	80204
8	National Jewish Medical and Research Center	Denver	Colorado	United States	80206
9	North Florida/South Georgia VA	Gainseville	Florida	United States	32608
10	Central Florida Pulmonary Group	Orlando	Florida	United States	32803
11	Weston Florida Cleveland Clinic	Weston	Florida	United States	33331
12	University of Illinois at Chicago	Chicago	Illinois	United States	60612
13	Suburban Lung Associates	Elk Grove Village	Illinois	United States	60007
14	Louisiana State University Health Sciences Center	New Orleans	Louisiana	United States	70112
15	University of Maryland	Baltimore	Maryland	United States	21201
16	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
17	Boston Medical Center	Boston	Massachusetts	United States	02118
18	Boston VA Medical Center	West Roxbury	Massachusetts	United States	02132
19	University of Michigan	Ann Arbor	Michigan	United States	48109
20	Beaumont Hospital	Royal Oak	Michigan	United States	48073
21	Washington University	St. Louis	Missouri	United States	63110
22	Pulmonary Consultants Inc./Christian Hospital	St. Louis	Missouri	United States	63136
23	Buffalo VAMC	Buffalo	New York	United States	14215
24	Crouse Medical Practice	Syracuse	New York	United States	13210
25	Duke University	Durham	North Carolina	United States	27710
26	Cincinnati VA Medical Center	Cincinnati	Ohio	United States	45220
27	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
28	Ohio State University	Columbus	Ohio	United States	43210
29	Kaiser Foundation Hospitals	Portland	Oregon	United States	97232
30	Geisinger Institute	Danville	Pennsylvania	United States	17822
31	Institute for Respiratory and Sleep Medicine	Langhorne	Pennsylvania	United States	19047
32	Temple University	Philadelphia	Pennsylvania	United States	19140
33	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
34	Respiratory Specialists	Wyomissing	Pennsylvania	United States	19610
35	University of Texas at San Antonio	San Antonio	Texas	United States	78249
36	University of Utah	Salt Lake City	Utah	United States	84132
37	Harborview Medical Center	Seattle	Washington	United States	98101
38	University of Washington	Seattle	Washington	United States	98101
39	Puget Sound VA Medical Center	Seattle	Washington	United States	98108

Sponsors and Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)
• Centers for Medicare and Medicaid Services

Investigators

• Study Chair: William C. Bailey, MD, University of Alabama at Birmingham Lung Health Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Click here for more information about the Long-term Oxygen Treatment Trial

Publications

None provided.

• Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
• ClinicalTrials.gov Identifier: NCT00692198
• Other Study ID Numbers: 583; N01HR76197-12-0-3
• First Posted: Jun 6, 2008
• Last Update Posted: May 10, 2017
• Last Verified: Nov 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by National Heart, Lung, and Blood Institute (NHLBI): COPD
• Additional relevant MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive

Study Results

Participant Flow

Arm/Group Title	Supplemental Oxygen Therapy (LTOT)	No Supplemental Oxygen Therapy (No LTOT)
Arm/Group Description	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.	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).
Period Title: Overall Study
STARTED	368	370
COMPLETED	368	370
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Supplemental Oxygen Therapy	No Supplemental Oxygen Therapy	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	368	370	738
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.3 (7.5)	69.3 (7.4)	68.8 (7.5)
Sex: Female, Male (Count of Participants)
Female	102 27.7%	94 25.4%	196 26.6%
Male	266 72.3%	276 74.6%	542 73.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	10 2.7%	4 1.1%	14 1.9%
Not Hispanic or Latino	358 97.3%	366 98.9%	724 98.1%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
African American only	46 12.5%	34 9.2%	80 10.8%
Caucasian only	299 81.3%	322 87%	621 84.1%
Other	23 6.3%	14 3.8%	37 5%
Region of Enrollment (participants) [Number]
United States	368 100%	370 100%	738 100%
Medicare coverage (Count of Participants)
Count of Participants [Participants]	268 72.8%	273 73.8%	541 73.3%
Current tobacco-cigarette smoker (Count of Participants)
Count of Participants [Participants]	110 29.9%	92 24.9%	202 27.4%
Quality of Well-Being Scale mean daily score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	0.56 (0.13)	0.56 (0.13)	0.56 (0.13)
St George's Respiratory Questionnaire total score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	49.8 (18.7)	50.2 (17.1)	50.0 (17.9)
Oxygen desaturation type qualifying patient for enrollment (Count of Participants)
Resting desaturation only	73 19.8%	60 16.2%	133 18%
Exercise desaturation only	148 40.2%	171 46.2%	319 43.2%
Resting and exercise	147 39.9%	139 37.6%	286 38.8%
SpO2 at rest while breathing ambient air (SpO2 (percent saturation)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [SpO2 (percent saturation)]	93.3 (2.1)	93.5 (1.9)	93.4 (2.0)
Nadir SpO2 during 6-min walk while breathing ambient air (Count of Participants)
Less than 86%	86 23.4%	85 23%	171 23.2%
86% through 88%	105 28.5%	103 27.8%	208 28.2%
Greater than 88%	101 27.4%	102 27.6%	203 27.5%
Unknown	76 20.7%	80 21.6%	156 21.1%

Outcome Measures

1. Primary Outcome

Title	Death or Hospitalization, Whichever Occurs First
Description	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.
Time Frame	Through study completion. Median follow-up was 18.4 months.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Supplemental Oxygen Therapy	No Supplemental Oxygen Therapy
Arm/Group Description	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.	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).
Measure Participants	368	370
Number [Composite events/100 person-years]	34.2	36.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supplemental Oxygen Therapy, No Supplemental Oxygen Therapy
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.52
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.94
	Confidence Interval	(2-Sided) 95%; 0.79 to 1.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Supplemental Oxygen Therapy	No Supplemental Oxygen Therapy
Arm/Group Description	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.	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).
Measure Participants	368	370
Number [Deaths/100 person-years]	5.2	5.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supplemental Oxygen Therapy, No Supplemental Oxygen Therapy
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.53
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.90
	Confidence Interval	(2-Sided) 95%; 0.64 to 1.25
	Parameter Dispersion	Type: Value:
	Estimation Comments	Hazard ratio, LTOT vs No LTOT

3. Secondary Outcome

Title	Health Care Utilization
Description	Health care utilization is measured by the rate of all hospitalizations.
Time Frame	Through study completion. Median follow-up was 18.4 months.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Supplemental Oxygen Therapy	No Supplemental Oxygen Therapy
Arm/Group Description	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.	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).
Measure Participants	368	370
Number [Hospitalizations per 100 person-years]	56.9	56.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supplemental Oxygen Therapy, No Supplemental Oxygen Therapy
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.81
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Rate ratio
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 95%; 0.91 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments	Rate ratio, LTOT vs No LTOT

4. Secondary Outcome

Title	Adherence
Description	Adherence is measured by self-reported hours of home oxygen per day
Time Frame	Through study completion. Median follow-up was 18.4 months.

Outcome Measure Data

Analysis Population Description

Patients providing at least 1 self-report are included.

Arm/Group Title	Supplemental Oxygen Therapy	No Supplemental Oxygen Therapy
Arm/Group Description	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.	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).
Measure Participants	368	363
Mean (Standard Deviation) [hours per day of supplemental oxygen]	13.6 (6.1)	1.8 (3.9)

5. Secondary Outcome

Title	COPD Exacerbation
Description	Rate of all COPD exacerbations
Time Frame	Through study completion. Median follow-up was 11.4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Supplemental Oxygen Therapy	No Supplemental Oxygen Therapy
Arm/Group Description	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.	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).
Measure Participants	368	370
Number [COPD exacerbations per 100 person-years]	73.1	67.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supplemental Oxygen Therapy, No Supplemental Oxygen Therapy
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.12
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Rate ratio
	Estimated Value	1.08
	Confidence Interval	(2-Sided) 95%; 0.98 to 1.19
	Parameter Dispersion	Type: Value:
	Estimation Comments	Rate ratio, LTOT vs No LTOT

6. Secondary Outcome

Title	Preference-weighted Health-related Quality of Life
Description	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.
Time Frame	Baseline to 1 year

Outcome Measure Data

Analysis Population Description

Participants with both the baseline and 1 year values were included

Arm/Group Title	Supplemental Oxygen Therapy	No Supplemental Oxygen Therapy
Arm/Group Description	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.	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).
Measure Participants	341	312
Mean (Standard Deviation) [units on a scale]	-0.04 (0.24)	-0.04 (0.14)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supplemental Oxygen Therapy, No Supplemental Oxygen Therapy
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.73
	Comments
	Method	t-test, 2 sided
	Comments

7. Secondary Outcome

Title	Disease-specific Quality of Life
Description	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.
Time Frame	Baseline to 1 year

Outcome Measure Data

Analysis Population Description

Participants with both the baseline and 1 year values are included

Arm/Group Title	Supplemental Oxygen Therapy	No Supplemental Oxygen Therapy
Arm/Group Description	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.	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).
Measure Participants	331	299
Mean (Standard Deviation) [units on a scale]	-1.1 (13.5)	0.6 (12.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supplemental Oxygen Therapy, No Supplemental Oxygen Therapy
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.21
	Comments
	Method	t-test, 2 sided
	Comments

8. Secondary Outcome

Title	General Quality of Life
Description	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.
Time Frame	Baseline to 1 year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Supplemental Oxygen Therapy	No Supplemental Oxygen Therapy
Arm/Group Description	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.	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).
Measure Participants	279	241
Mean (Standard Deviation) [units on a scale]	-0.5 (7.1)	-1.0 (7.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supplemental Oxygen Therapy, No Supplemental Oxygen Therapy
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.71
	Comments
	Method	t-test, 2 sided
	Comments

9. Secondary Outcome

Title	Sleep Quality
Description	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.
Time Frame	Baseline to 1 year

Outcome Measure Data

Analysis Population Description

Participants with both the baseline and 1 year values are included

Arm/Group Title	Supplemental Oxygen Therapy	No Supplemental Oxygen Therapy
Arm/Group Description	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.	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).
Measure Participants	274	240
Mean (Standard Deviation) [units on a scale]	-0.3 (3.4)	0.4 (3.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supplemental Oxygen Therapy, No Supplemental Oxygen Therapy
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments
	Method	t-test, 2 sided
	Comments

10. Secondary Outcome

Title	Anxiety
Description	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
Time Frame	Baseline to 1 year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Supplemental Oxygen Therapy	No Supplemental Oxygen Therapy
Arm/Group Description	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.	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).
Measure Participants	280	243
Mean (Standard Deviation) [units on a scale]	-0.1 (3.3)	0.3 (3.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supplemental Oxygen Therapy, No Supplemental Oxygen Therapy
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.28
	Comments
	Method	t-test, 2 sided
	Comments

11. Secondary Outcome

Title	Depression
Description	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
Time Frame	Baseline to 1 year

Outcome Measure Data

Analysis Population Description

Patients with both baseline and 1 year values are included

Arm/Group Title	Supplemental Oxygen Therapy	No Supplemental Oxygen Therapy
Arm/Group Description	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.	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).
Measure Participants	280	243
Mean (Standard Deviation) [units on a scale]	0.4 (3.0)	0.7 (2.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supplemental Oxygen Therapy, No Supplemental Oxygen Therapy
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.41
	Comments
	Method	t-test, 2 sided
	Comments

12. Secondary Outcome

Title	Development of Severe Resting Desaturation
Description	Severe resting desaturation is defined as resting room air SpO2 <=88%
Time Frame	Baseline to 1 year

Outcome Measure Data

Analysis Population Description

Participants completing the 1 year saturation assessment are analyzed

Arm/Group Title	Supplemental Oxygen Therapy	No Supplemental Oxygen Therapy
Arm/Group Description	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.	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).
Measure Participants	322	288
Count of Participants [Participants]	7 1.9%	3 0.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supplemental Oxygen Therapy, No Supplemental Oxygen Therapy
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	2.09
	Confidence Interval	(2-Sided) 95%; 0.54 to 8.00
	Parameter Dispersion	Type: Value:
	Estimation Comments	Relative risk, LTOT vs No LTOT

13. Secondary Outcome

Title	6-minute Walk Distance
Description	Change in distance walked during 6-minute walk test, follow-up value minus baseline value (feet)
Time Frame	Baseline to 1 year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Supplemental Oxygen Therapy	No Supplemental Oxygen Therapy
Arm/Group Description	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.	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).
Measure Participants	291	267
Mean (Standard Deviation) [feet]	-53 (281)	-85 (245)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supplemental Oxygen Therapy, No Supplemental Oxygen Therapy
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.37
	Comments
	Method	t-test, 2 sided
	Comments

14. Secondary Outcome

Title	Dyspnea
Description	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.
Time Frame	Baseline to 1 year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Supplemental Oxygen Therapy	No Supplemental Oxygen Therapy
Arm/Group Description	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.	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).
Measure Participants	331	299
Mean (Standard Deviation) [units on a scale]	-1.1 (13.5)	0.6 (12.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supplemental Oxygen Therapy, No Supplemental Oxygen Therapy
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.21
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	Through study completion. Median follow-up of 41.5 months
Adverse Event Reporting Description	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.
Arm/Group Title	Supplemental Oxygen Therapy		Patients Crossing Over to Supplemental Oxygen Therapy		No Supplemental Oxygen
Arm/Group Description	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.		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		Participants in the No supplemental oxygen who did not receive home oxygen during their participation in the trial.
All Cause Mortality
	Supplemental Oxygen Therapy		Patients Crossing Over to Supplemental Oxygen Therapy		No Supplemental Oxygen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	66/368 (17.9%)		24/125 (19.2%)		49/245 (20%)
Serious Adverse Events
	Supplemental Oxygen Therapy		Patients Crossing Over to Supplemental Oxygen Therapy		No Supplemental Oxygen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/368 (0.5%)		0/125 (0%)		0/245 (0%)
General disorders
Event attributed to supplemental oxygen required hospitalization	2/368 (0.5%)	2	0/125 (0%)	0	0/245 (0%)	0
Other (Not Including Serious) Adverse Events
	Supplemental Oxygen Therapy		Patients Crossing Over to Supplemental Oxygen Therapy		No Supplemental Oxygen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	30/368 (8.2%)		10/125 (8%)		0/245 (0%)
Ear and labyrinth disorders
Nosebleed	4/368 (1.1%)	4	4/125 (3.2%)	5	0/245 (0%)	0
Funny feeling in sinus area	1/368 (0.3%)	1	0/125 (0%)	0	0/245 (0%)	0
Eye disorders
Dry eyes	1/368 (0.3%)	1	0/125 (0%)	0	0/245 (0%)	0
Gastrointestinal disorders
Increased intestinal gas	1/368 (0.3%)	1	0/125 (0%)	0	0/245 (0%)	0
General disorders
Headache	2/368 (0.5%)	2	0/125 (0%)	0	0/245 (0%)	0
Nausea	1/368 (0.3%)	1	0/125 (0%)	0	0/245 (0%)	0
Injury, poisoning and procedural complications
Burn from smoking around oxygen equipment	2/368 (0.5%)	3	0/125 (0%)	0	0/245 (0%)	0
Burn from using oxygen equipment around open flame	0/368 (0%)	0	1/125 (0.8%)	1	0/245 (0%)	0
Burn from liquid oxygen frost	3/368 (0.8%)	3	1/125 (0.8%)	1	0/245 (0%)	0
Tripping/falling over oxygen equipment not resulting in hospitalization	13/368 (3.5%)	17	4/125 (3.2%)	4	0/245 (0%)	0
Product Issues
Fires related to oxygen use	2/368 (0.5%)	2	0/125 (0%)	0	0/245 (0%)	0
Skin and subcutaneous tissue disorders
Blisters on ears and ear pain	3/368 (0.8%)	3	0/125 (0%)	0	0/245 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.