Long-term Oxygen Treatment Trial (LOTT)

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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).

Participant Flow:   Overall Study

	Supplemental Oxygen Therapy (LTOT)	No Supplemental Oxygen Therapy (No LTOT)
STARTED	368	370
COMPLETED	368	370
NOT COMPLETED	0	0

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Supplemental Oxygen Therapy	Participants will receive treatment with supplemental oxygen therapy. Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep.
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).
Total	Total of all reporting groups

Baseline Measures

	Supplemental Oxygen Therapy	No Supplemental Oxygen Therapy	Total
Overall Participants Analyzed  [Units: Participants]	368	370	738
Age  [Units: Years] Mean (Standard Deviation)	68.3  (7.5)	69.3  (7.4)	68.8  (7.5)
Sex: Female, Male  [Units: Participants] 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)  [Units: Participants] 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%	0   0.0%
Race/Ethnicity, Customized  [Units: Participants] Count of Participants
Race
African American only	46  12.5%	34   9.2%	80  10.8%
Caucasian only	299  81.3%	322  87.0%	621  84.1%
Other	23   6.3%	14   3.8%	37   5.0%
Region of Enrollment  [Units: Participants]
United States	368	370	738
Medicare coverage  [Units: Participants] Count of Participants	268	273	541
Current tobacco-cigarette smoker  [Units: Participants] Count of Participants	110	92	202
Quality of Well-Being Scale mean daily score [1]  [Units: Units on a scale] Mean (Standard Deviation)	0.56  (0.13)	0.56  (0.13)	0.56  (0.13)
[1] The Quality of Well Being questionnaire measures health related quality of life and is comprised of of 79 self reported items. The total daily score ranges from 0 to 1, with higher score indicating higher quality of life.
St George's Respiratory Questionnaire total score [1]  [Units: Units on a scale] Mean (Standard Deviation)	49.8  (18.7)	50.2  (17.1)	50.0  (17.9)
[1] The St George's Respiratory Questionnaire measures the impact of chest disease on daily life and well-being and is comprised of 51 items. The total score ranges from 0 to 100 with lower scores indicating better functioning.
Oxygen desaturation type qualifying patient for enrollment  [Units: Participants] Count of Participants
Resting desaturation only	73  19.8%	60  16.2%	133  18.0%
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  [Units: SpO2 (percent saturation)] Mean (Standard Deviation)	93.3  (2.1)	93.5  (1.9)	93.4  (2.0)
Nadir SpO2 during 6-min walk while breathing ambient air  [Units: Participants] Count of Participants
Less than 86%	86  23.4%	85  23.0%	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%

1.  Primary:

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

2.  Secondary:

Death   [ Time Frame: Through study completion. Median follow-up was 41.5 months. ]

3.  Secondary:

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

4.  Secondary:

Adherence   [ Time Frame: Through study completion. Median follow-up was 18.4 months. ]

5.  Secondary:

COPD Exacerbation   [ Time Frame: Through study completion. Median follow-up was 11.4 months ]

6.  Secondary:

Preference-weighted Health-related Quality of Life   [ Time Frame: Baseline to 1 year ]

7.  Secondary:

Disease-specific Quality of Life   [ Time Frame: Baseline to 1 year ]

8.  Secondary:

General Quality of Life   [ Time Frame: Baseline to 1 year ]

9.  Secondary:

Sleep Quality   [ Time Frame: Baseline to 1 year ]

10.  Secondary:

Anxiety   [ Time Frame: Baseline to 1 year ]

11.  Secondary:

Depression   [ Time Frame: Baseline to 1 year ]

12.  Secondary:

Development of Severe Resting Desaturation   [ Time Frame: Baseline to 1 year ]

13.  Secondary:

6-minute Walk Distance   [ Time Frame: Baseline to 1 year ]

14.  Secondary:

Dyspnea   [ Time Frame: Baseline to 1 year ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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