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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
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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 



  Baseline Characteristics
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  Outcome Measures
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1.  Primary:   Death or Hospitalization, Whichever Occurs First   [ Time Frame: Through study completion. Median follow-up was 18.4 months. ]
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2.  Secondary:   Death   [ Time Frame: Through study completion. Median follow-up was 41.5 months. ]
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3.  Secondary:   Health Care Utilization   [ Time Frame: Through study completion. Median follow-up was 18.4 months. ]
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4.  Secondary:   Adherence   [ Time Frame: Through study completion. Median follow-up was 18.4 months. ]
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5.  Secondary:   COPD Exacerbation   [ Time Frame: Through study completion. Median follow-up was 11.4 months ]
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6.  Secondary:   Preference-weighted Health-related Quality of Life   [ Time Frame: Baseline to 1 year ]
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7.  Secondary:   Disease-specific Quality of Life   [ Time Frame: Baseline to 1 year ]
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8.  Secondary:   General Quality of Life   [ Time Frame: Baseline to 1 year ]
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9.  Secondary:   Sleep Quality   [ Time Frame: Baseline to 1 year ]
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10.  Secondary:   Anxiety   [ Time Frame: Baseline to 1 year ]
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11.  Secondary:   Depression   [ Time Frame: Baseline to 1 year ]
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12.  Secondary:   Development of Severe Resting Desaturation   [ Time Frame: Baseline to 1 year ]
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13.  Secondary:   6-minute Walk Distance   [ Time Frame: Baseline to 1 year ]
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14.  Secondary:   Dyspnea   [ Time Frame: Baseline to 1 year ]
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  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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  More Information
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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