Long-term Oxygen Treatment Trial

Chronic Obstructive Pulmonary Disease Clinical Trial

— LOTT  

Official title:

Effectiveness of Long-term Oxygen Therapy in Treating People With Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00692198
• Other study ID #: 583
• Secondary ID: N01HR76197-12-0-
• Status: Completed
• Phase: Phase 3
• First received: June 4, 2008
• Last updated: October 28, 2016
• Start date: January 2009
• Est. completion date: August 2015

Study information

• Verified date: October 2015
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 738
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Maryland	Baltimore	Maryland
United States	Birmingham VA Medical Center	Birmingham	Alabama
United States	University of Alabama	Birmingham	Alabama
United States	Boston Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Buffalo VAMC	Buffalo	New York
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Cincinnati VA Medical Center	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Geisinger Institute	Danville	Pennsylvania
United States	Denver Health and Hospital Authority	Denver	Colorado
United States	National Jewish Medical and Research Center	Denver	Colorado
United States	City of Hope National Medical Center	Duarte	California
United States	Duke University	Durham	North Carolina
United States	Suburban Lung Associates	Elk Grove Village	Illinois
United States	North Florida/South Georgia VA	Gainseville	Florida
United States	Institute for Respiratory and Sleep Medicine	Langhorne	Pennsylvania
United States	Loma Linda VA Medical Center	Loma Linda	California
United States	Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center	Los Angeles	California
United States	Louisiana State University Health Sciences Center	New Orleans	Louisiana
United States	Central Florida Pulmonary Group	Orlando	Florida
United States	Temple University	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Kaiser Foundation Hospitals	Portland	Oregon
United States	Beaumont Hospital	Royal Oak	Michigan
United States	University of Utah	Salt Lake City	Utah
United States	University of Texas at San Antonio	San Antonio	Texas
United States	UCSD Medical Center	San Diego	California
United States	Harborview Medical Center	Seattle	Washington
United States	Puget Sound VA Medical Center	Seattle	Washington
United States	University of Washington	Seattle	Washington
United States	Pulmonary Consultants Inc./Christian Hospital	St. Louis	Missouri
United States	Washington University	St. Louis	Missouri
United States	Crouse Medical Practice	Syracuse	New York
United States	Boston VA Medical Center	West Roxbury	Massachusetts
United States	Weston Florida Cleveland Clinic	Weston	Florida
United States	Respiratory Specialists	Wyomissing	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)	Centers for Medicare and Medicaid Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death or hospitalization		Measured every 4 months for up to 7 years	No
Secondary	Disease-specific quality of life		Measured twice in year 1, twice in year 2, once in each of years 3-6	No
Secondary	Preference-weighted health-related quality of life		Measured twice in year 1, twice in year 2, once in each of years 3-6	No
Secondary	Quality-adjusted survival		Measured every 4 months for up to 7 years	No
Secondary	Health care utilization		Measured every 4 months for up to 7 years	No
Secondary	Maintenance of nutritional status (e.g., body mass index)		Measured once per year for up to 7 years	No
Secondary	General quality of life		Measured once per year for up to 7 years	No
Secondary	Sleep quality		Measured once per year for up to 7 years	No
Secondary	Depression and anxiety		Measured once per year for up to 7 years	No
Secondary	Onset of severe hypoxemia (defined as room air oxygen saturation less than or equal to 88%)		Measured once per year for up to 7 years	No
Secondary	6-minute walk distance		Measured once per year for up to 7 years	No
Secondary	Dyspnea		Measured once per year for up to 7 years	No
Secondary	COPD exacerbation rate		Measured every 4 months for up to 7 years	No
Secondary	Adherence to supplemental oxygen		Measured every 2 months for up to 7 years	No
Secondary	Risk of cardiovascular disease		Measured every 4 months for up to 7 years	No
Secondary	Cost effectiveness		Assessed at end of trial using quality adjusted survival	No

External Links

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