Chronic Obstructive Pulmonary Disease Clinical Trial
— LOTTOfficial title:
Effectiveness of Long-term Oxygen Therapy in Treating People With Chronic Obstructive Pulmonary Disease
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
National Heart, Lung, and Blood Institute (NHLBI) | Centers for Medicare and Medicaid Services |
United States,
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 |
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