Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
Trial record 1 of 89 for:    Long Term Oxygen Treatment trial
Previous Study | Return to List | Next Study

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
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
  Show All Outcome Measures

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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide 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.


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 ( US NIH Grant/Contract Award Number )
Study First Received: June 4, 2008
Results First Received: November 10, 2016
Last Updated: April 3, 2017