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Long-term Oxygen Treatment Trial (LOTT)

This study has been completed.
Sponsor:
Collaborator:
Centers for Medicare and Medicaid Services
Information provided by (Responsible Party):
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00692198
First received: June 4, 2008
Last updated: April 3, 2017
Last verified: November 2016
History of Changes
Results First Received: November 10, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease
Intervention: Drug: Supplemental oxygen therapy

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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 



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

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% 


  Outcome Measures
  Hide All Outcome Measures

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

Measure Type Primary
Measure Title Death or Hospitalization, Whichever Occurs First
Measure 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.  

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.
No text entered.

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) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).

Measured Values
   Supplemental Oxygen Therapy   No Supplemental Oxygen Therapy 
Participants Analyzed 
[Units: Participants]
 		 368   370 
Death or Hospitalization, Whichever Occurs First 
[Units: Composite events/100 person-years]
 		 34.2   36.4 


Statistical Analysis 1 for Death or Hospitalization, Whichever Occurs First
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Log Rank
P Value [4] 0.52
Hazard Ratio (HR) [5] 0.94
95% Confidence Interval 0.79 to 1.12
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



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

Measure Type Secondary
Measure Title Death
Measure 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.  

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.
No text entered.

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) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).

Measured Values
   Supplemental Oxygen Therapy   No Supplemental Oxygen Therapy 
Participants Analyzed 
[Units: Participants]
 		 368   370 
Death 
[Units: Deaths/100 person-years]
 		 5.2   5.7 


Statistical Analysis 1 for Death
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Log Rank
P Value [4] 0.53
Hazard Ratio (HR) [5] 0.90
95% Confidence Interval 0.64 to 1.25
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  Hazard ratio, LTOT vs No LTOT



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

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

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.
No text entered.

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) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).

Measured Values
   Supplemental Oxygen Therapy   No Supplemental Oxygen Therapy 
Participants Analyzed 
[Units: Participants]
 		 368   370 
Health Care Utilization 
[Units: Hospitalizations per 100 person-years]
 		 56.9   56.2 


Statistical Analysis 1 for Health Care Utilization
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Fisher Exact
P Value [4] 0.81
Rate ratio [5] 1.01
95% Confidence Interval 0.91 to 1.13
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  Rate ratio, LTOT vs No LTOT



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

Measure Type Secondary
Measure Title Adherence
Measure 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.  

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

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) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).

Measured Values
   Supplemental Oxygen Therapy   No Supplemental Oxygen Therapy 
Participants Analyzed 
[Units: Participants]
 		 368   363 
Adherence 
[Units: Hours per day of supplemental oxygen]
Mean (Standard Deviation) 		 13.6  (6.1)   1.8  (3.9) 

No statistical analysis provided for Adherence



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

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

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.
No text entered.

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) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).

Measured Values
   Supplemental Oxygen Therapy   No Supplemental Oxygen Therapy 
Participants Analyzed 
[Units: Participants]
 		 368   370 
COPD Exacerbation 
[Units: COPD exacerbations per 100 person-years]
 		 73.1   67.7 


Statistical Analysis 1 for COPD Exacerbation
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Fisher Exact
P Value [4] 0.12
Rate ratio [5] 1.08
95% Confidence Interval 0.98 to 1.19
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  Rate ratio, LTOT vs No LTOT



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

Measure Type Secondary
Measure Title Preference-weighted Health-related Quality of Life
Measure 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  

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.
Participants with both the baseline and 1 year values were included

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) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).

Measured Values
   Supplemental Oxygen Therapy   No Supplemental Oxygen Therapy 
Participants Analyzed 
[Units: Participants]
 		 341   312 
Preference-weighted Health-related Quality of Life 
[Units: Units on a scale]
Mean (Standard Deviation) 		 -0.04  (0.24)   -0.04  (0.14) 


Statistical Analysis 1 for Preference-weighted Health-related Quality of Life
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] t-test, 2 sided
P Value [4] 0.73
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



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

Measure Type Secondary
Measure Title Disease-specific Quality of Life
Measure 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  

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.
Participants with both the baseline and 1 year values are included

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) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).

Measured Values
   Supplemental Oxygen Therapy   No Supplemental Oxygen Therapy 
Participants Analyzed 
[Units: Participants]
 		 331   299 
Disease-specific Quality of Life 
[Units: Units on a scale]
Mean (Standard Deviation) 		 -1.1  (13.5)   0.6  (12.7) 


Statistical Analysis 1 for Disease-specific Quality of Life
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] t-test, 2 sided
P Value [4] 0.21
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



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

Measure Type Secondary
Measure Title General Quality of Life
Measure 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  

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

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) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).

Measured Values
   Supplemental Oxygen Therapy   No Supplemental Oxygen Therapy 
Participants Analyzed 
[Units: Participants]
 		 279   241 
General Quality of Life 
[Units: Units on a scale]
Mean (Standard Deviation) 		 -0.5  (7.1)   -1.0  (7.4) 


Statistical Analysis 1 for General Quality of Life
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] t-test, 2 sided
P Value [4] 0.71
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



9.  Secondary:   Sleep Quality   [ Time Frame: Baseline to 1 year ]

Measure Type Secondary
Measure Title Sleep Quality
Measure 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  

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.
Participants with both the baseline and 1 year values are included

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) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).

Measured Values
   Supplemental Oxygen Therapy   No Supplemental Oxygen Therapy 
Participants Analyzed 
[Units: Participants]
 		 274   240 
Sleep Quality 
[Units: Units on a scale]
Mean (Standard Deviation) 		 -0.3  (3.4)   0.4  (3.2) 


Statistical Analysis 1 for Sleep Quality
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] t-test, 2 sided
P Value [4] 0.03
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



10.  Secondary:   Anxiety   [ Time Frame: Baseline to 1 year ]

Measure Type Secondary
Measure Title Anxiety
Measure 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  

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

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) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).

Measured Values
   Supplemental Oxygen Therapy   No Supplemental Oxygen Therapy 
Participants Analyzed 
[Units: Participants]
 		 280   243 
Anxiety 
[Units: Units on a scale]
Mean (Standard Deviation) 		 -0.1  (3.3)   0.3  (3.2) 


Statistical Analysis 1 for Anxiety
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] t-test, 2 sided
P Value [4] 0.28
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



11.  Secondary:   Depression   [ Time Frame: Baseline to 1 year ]

Measure Type Secondary
Measure Title Depression
Measure 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  

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.
Patients with both baseline and 1 year values are included

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) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).

Measured Values
   Supplemental Oxygen Therapy   No Supplemental Oxygen Therapy 
Participants Analyzed 
[Units: Participants]
 		 280   243 
Depression 
[Units: Units on a scale]
Mean (Standard Deviation) 		 0.4  (3.0)   0.7  (2.8) 


Statistical Analysis 1 for Depression
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] t-test, 2 sided
P Value [4] 0.41
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



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

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

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.
Participants completing the 1 year saturation assessment are analyzed

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) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).

Measured Values
   Supplemental Oxygen Therapy   No Supplemental Oxygen Therapy 
Participants Analyzed 
[Units: Participants]
 		 322   288 
Development of Severe Resting Desaturation 
[Units: Participants]
Count of Participants 		 7   3 


Statistical Analysis 1 for Development of Severe Resting Desaturation
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Risk Ratio (RR) [3] 2.09
95% Confidence Interval 0.54 to 8.00
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  Relative risk, LTOT vs No LTOT



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

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

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

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) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).

Measured Values
   Supplemental Oxygen Therapy   No Supplemental Oxygen Therapy 
Participants Analyzed 
[Units: Participants]
 		 291   267 
6-minute Walk Distance 
[Units: Feet]
Mean (Standard Deviation) 		 -53  (281)   -85  (245) 


Statistical Analysis 1 for 6-minute Walk Distance
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] t-test, 2 sided
P Value [4] 0.37
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



14.  Secondary:   Dyspnea   [ Time Frame: Baseline to 1 year ]

Measure Type Secondary
Measure Title Dyspnea
Measure 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  

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

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) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).

Measured Values
   Supplemental Oxygen Therapy   No Supplemental Oxygen Therapy 
Participants Analyzed 
[Units: Participants]
 		 331   299 
Dyspnea 
[Units: Units on a scale]
Mean (Standard Deviation) 		 -1.1  (13.5)   0.6  (12.7) 


Statistical Analysis 1 for Dyspnea
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] t-test, 2 sided
P Value [4] 0.21
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.




  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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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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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.


Results Point of Contact:  
Name/Title: James Tonascia, PhD
Organization: Johns Hopkins Bloomberg School of Public Health
phone: 410-955-8175
e-mail: jtonasc1@jhu.edu


Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00692198     History of Changes
Other Study ID Numbers: 583
N01HR76197-12-0-3 ( U.S. NIH Grant/Contract )
Study First Received: June 4, 2008
Results First Received: November 10, 2016
Last Updated: April 3, 2017