Trial record 1 of 51 for:    Long Term Oxygen Treatment trial
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Effectiveness of Long-term Oxygen Therapy in Treating People With Chronic Obstructive Pulmonary Disease (The Long-term Oxygen Treatment Trial [LOTT])

This study is currently recruiting participants.
Verified July 2013 by National Heart, Lung, and Blood Institute (NHLBI)
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: July 18, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Behavioral: Supplemental oxygen therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-term Oxygen Treatment Trial

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Death or hospitalization [ Time Frame: Measured every 4 months for up to 7 years ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 737
Study Start Date: January 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive treatment with supplemental oxygen therapy.
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.
No Intervention: 2
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).

Detailed 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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00692198

Contacts
Contact: Alice Sternberg, ScM 410-955-3752 asternbe@jhsph.edu

  Hide Study Locations
Locations
United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35294
Contact: Patti Smith    205-996-5392    patti.smith2@va.gov   
Contact: Allen Cooper, MD    205-934-1339    allenc@uab.edu   
Principal Investigator: Allen Cooper, MD         
Sub-Investigator: Kathleen Harrington, PhD         
Sub-Investigator: Mark Dransfield, MD         
Birmingham VA Medical Center Recruiting
Birmingham, Alabama, United States, 35233
Contact: Patti Smith    205-933-8101 ext 2182    patti.smith2@va.gov   
Contact: Allen Cooper, MD    205-934-1339    allenc@uab.edu   
Principal Investigator: Allen Cooper, MD         
United States, California
City of Hope National Medical Center Active, not recruiting
Duarte, California, United States, 91010
Loma Linda VA Medical Center Recruiting
Loma Linda, California, United States, 92357
Contact: Jamie Portillo    909-583-6368    jamie.portillo@va.gov   
Contact: Lennard Specht, MD    909-583-6098    lennard.specht@va.gov   
Principal Investigator: Richard Casaburi, MD, PhD         
Sub-Investigator: Lennard Specht, MD         
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center Recruiting
Los Angeles, California, United States, 90502
Contact: Peggy Walker    310-222-8200    pwalker@labiomed.org   
Contact: Richard Casaburi, MD, PhD    310-222-8200    casaburi@ucla.edu   
Principal Investigator: Richard Casaburi, MD, PhD         
Sub-Investigator: Janos Porszasz, MD         
UCSD Medical Center Recruiting
San Diego, California, United States, 92103
Contact: Arianna Villa    619-543-7542    a1nunn@ucsd.edu   
Principal Investigator: Roger Yusen, MD         
Sub-Investigator: Xavier Soler, MD, PhD         
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Christine Verano    720-848-0757    chris.verano@ucdenver.edu   
Contact: Marvin Schwartz    303-724-4075    marvin.schwartz@ucdenver.edu   
Principal Investigator: Richard Albert, MD         
Sub-Investigator: Marvin Schwartz, MD         
Denver Health and Hospital Authority Recruiting
Denver, Colorado, United States, 80204
Contact: Christine Verano, RN, BSN    720-848-0757    chris.verano@uchsc.edu   
Contact: Richard Albert, MD    303-436-6900    rick.albert@dhha.org   
Principal Investigator: Richard Albert, MD         
Sub-Investigator: Barry Make, MD         
National Jewish Medical and Research Center Recruiting
Denver, Colorado, United States, 80206
Contact: Jennifer Underwood    303-398-1518    underwoodj@njhealth.org   
Contact: Barry Make, MD    303-398-1703    makeb@njhealth.org   
Principal Investigator: Richard Albert, MD         
Sub-Investigator: Barry Make, MD         
United States, Florida
North Florida/South Georgia VA Recruiting
Gainseville, Florida, United States, 32608
Contact: Katherine Herring    352-376-1611 ext 4599    omerea.herring@va.gov   
Principal Investigator: Allen Cooper, MD         
Sub-Investigator: Peruvemba Sriram, MD         
Central Florida Pulmonary Group Recruiting
Orlando, Florida, United States, 32803
Contact: Sondra Sadler    407-841-1100 ext 118    ssadler@cfpulmonary.com   
Principal Investigator: Roger Yusen, MD         
Sub-Investigator: Daniel Layish, MD         
Weston Florida Cleveland Clinic Recruiting
Weston, Florida, United States, 33331
Contact: Jean Barton    954-659-6213    bartonn2@ccf.org   
Principal Investigator: James Stoller, MD         
Sub-Investigator: Frank Rahaghi, MD         
United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Nina Grude    312-996-0927    ngrude@uic.edu   
Principal Investigator: Roger Yusen, MD         
Sub-Investigator: Min Joo, MD         
Suburban Lung Associates Recruiting
Elk Grove Village, Illinois, United States, 60007
Contact: Mary Joseph, PhD    847-530-4776    mary.joseph@sublung.com   
Principal Investigator: Roger Yusen, MD         
Sub-Investigator: Edward Diamond, MD         
United States, Louisiana
Louisiana State University Health Sciences Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Connie Romaine    504-568-3452    cromai@lsuhsc.edu   
Principal Investigator: Gerard Criner, MD         
Sub-Investigator: Matthew Lammi, MD         
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Tom Fitzgerald    410-706-3355    tfitzger@medicine.umaryland.edu   
Contact: Steven Scharf, MD, PhD    410-706-4771    sscharf@medicine.umaryland.edu   
Principal Investigator: Gerard Criner, MD         
Sub-Investigator: Steven Scharf, MD, PhD         
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Tina Sampong    617-732-6272    esampong@partners.org   
Contact: Anne Fuhlbrigge, MD    617-525-6645    afuhlbrigge@partners.org   
Principal Investigator: Anne Fuhlbrigge, MD, MS         
Sub-Investigator: George Washko, MD         
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Ashley Wagner    857-364-2576    wagneram@bu.edu   
Contact: Karin Sloan, MD    617-638-4814    kasloan@bu.edu   
Principal Investigator: Anne Fuhlbrigge, MD, MS         
Sub-Investigator: Karin Sloan, MD         
Boston VA Medical Center Recruiting
West Roxbury, Massachusetts, United States, 02132
Contact: Enoma Okunbor    857-203-5147    osarenoma.okunbor@va.gov   
Contact: Marilyn Moy, MD    857-203-6622    marilyn.moy@va.gov   
Principal Investigator: Anne Fuhlbrigge, MD, MS         
Sub-Investigator: Marilyn Moy, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Kelly Rysso    734-647-7840    kahernan@med.umich.edu   
Contact: Fernando Martinez, MD    734-763-2540    fmartine@umich.edu   
Principal Investigator: Fernando Martinez, MD         
Sub-Investigator: Jeffrey Curtis, MD         
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Lana Saugrich    313-916-2568    lsaugri9@hfhs.org   
Contact: Michael Eichenhorn, MD    313-916-2436    meichen1@hfhs.org   
Principal Investigator: Fernando Martinez, MD         
Sub-Investigator: Michael Eichenhorn, MD         
Spectrum Health Hospitals Not yet recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Jennifer Cannestra    616-391-2904    jennifer.cannestra@spectrumhealth.org   
Principal Investigator: Fernando Martinez, MD         
Sub-Investigator: Reda Girgis, MD         
Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Jennifer DeRidder, RN    248-898-4578    jderidder@beaumonthospitals.com   
Contact: K P Ravikrishnan, MD    248-551-0497    kravikrishnan@beaumont.edu   
Principal Investigator: Fernando Martinez, MD         
Sub-Investigator: K P Ravikrishnan, MD         
United States, Missouri
Washington University Recruiting
St. Louis, Missouri, United States, 63110
Contact: Jeanne Heaghney, RN    314-747-1610    jheaghne@dom.wustl.edu   
Contact: Roger Yusen, MD    314-454-8764    ryusen@dom.wustl.edu   
Principal Investigator: Roger Yusen, MD, MPH         
Sub-Investigator: Mario Castro, MD, MPH         
Pulmonary Consultants Inc./Christian Hospital Recruiting
St. Louis, Missouri, United States, 63136
Contact: Jeanne Heaghney, RN    314-747-1610    jheaghne@dom.wustl.edu   
Principal Investigator: Roger Yusen, MD, MPH         
Sub-Investigator: Myron Jacobs, MD, FCCP         
United States, New York
Albany Medical College Recruiting
Albany, New York, United States, 12208
Contact: Haroon Chaudhry    518-262-1542    chaudhh@mail.amc.edu   
Principal Investigator: Gerard Criner, MD         
Sub-Investigator: Marc Judson, MD         
Buffalo VAMC Recruiting
Buffalo, New York, United States, 14215
Contact: Ayesha Rahman    716-862-8944    ayesha.rahman2@va.gov   
Sub-Investigator: Jeffery Mador, MD         
Principal Investigator: Gerard Criner, MD         
Crouse Medical Practice Recruiting
Syracuse, New York, United States, 13210
Contact: Christine Jocko    315-479-5070 ext 6122    christinejocko@iacny.com   
Sub-Investigator: Stephan Alkins, MD         
Principal Investigator: James Stoller, MD         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: John Davies    919-681-4602    john.davies@duke.edu   
Contact: Neil MacIntyre, MD    919-681-2720    macin001@mc.duke.edu   
Principal Investigator: Neil MacIntyre, MD         
Sub-Investigator: Yuh-Chin Tony Huang, MD, MHS         
United States, Ohio
Cincinnati VA Medical Center Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Laura Lach    513-861-3100 ext 4557    laura.lach@va.gov   
Contact: Ralph Panos, MD    513-861-3100 ext 4500    panosrj@ucmail.uc.edu   
Principal Investigator: Philip Diaz, MD         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Yvonne Meli    216-445-4215    meliy@ccf.org   
Contact: James Stoller, MD    215-444-1960    stollej@ccf.org   
Principal Investigator: James Stoller, MD, MS         
Sub-Investigator: Kingman Strohl, MD         
Sub-Investigator: Jeffrey Kern, MD         
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Janice Drake    614-366-2287    janice.drake@osumc.edu   
Contact: Philip Diaz, MD    614-293-4925    philip.diaz@osumc.edu   
Principal Investigator: Philip Diaz, MD         
Sub-Investigator: Ralph Panos, MD         
United States, Oregon
Kaiser Foundation Hospitals Active, not recruiting
Portland, Oregon, United States, 97232
United States, Pennsylvania
Geisinger Institute Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Michele Mitchell    570-271-6655    mmitchell@geisinger.edu   
Contact: Paul Simonelli, MD    570-271-6655    pfsimonelli@geisinger.edu   
Principal Investigator: Gerard Criner, MD         
Sub-Investigator: Paul Simonelli, MD         
Institute for Respiratory and Sleep Medicine Recruiting
Langhorne, Pennsylvania, United States, 19047
Contact: Mary Ianacone    856-866-0498    peterserp@comcast.net   
Contact: Howard Lee, MD    215-757-1414    sn00zedoc.lee@gmail.com   
Principal Investigator: Gerard Criner, MD         
Sub-Investigator: Howard Lee, MD         
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Carla Grabianowski, RN, BSN    215-707-1359    carla.grabianowski@tuhs.temple.edu   
Contact: Gerard Criner, MD    215-707-8113    gerard.criner@tuhs.temple.edu   
Principal Investigator: Gerard Criner, MD         
Sub-Investigator: Steven Scharf, MD, PhD         
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Joe Mastalski    412-683-7692    mastalskijp@upmc.edu   
Principal Investigator: Frank Sciurba, MD         
Sub-Investigator: Charles Atwood, MD         
Respiratory Specialists Recruiting
Wyomissing, Pennsylvania, United States, 19610
Contact: Lisa Hill    610-685-5864    lhill@lungmd.net   
Principal Investigator: Gerard Criner, MD         
Sub-Investigator: Alec Platt, MD         
United States, Texas
University of Texas at San Antonio Recruiting
San Antonio, Texas, United States, 78249
Contact: Clinton Ezekiel    210-617-5300 ext 16875    clinton.ezekiel@va.gov   
Principal Investigator: Fernando Martinez, MD         
Sub-Investigator: Antonio Anzueto, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Martin Villegas    801-581-5864    martin.villegas@hsc.utah.edu   
Contact: Richard Kanner, MD    801-581-7806    richard.kanner@hsc.utah.edu   
Principal Investigator: Richard Kanner, MD         
Sub-Investigator: Mary Beth Scholand, MD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98101
Contact: Edmunds Udris    206-764-2504    ed.udris@va.gov   
Contact: David Au, MD, MS    206-277-6132    dau@u.washington.edu   
Principal Investigator: David Au, MD, MS         
Sub-Investigator: Bruce Culver, MD         
Puget Sound VA Medical Center Recruiting
Seattle, Washington, United States, 98108
Contact: Edmunds Udris    206-764-2504    ed.udris@va.gov   
Contact: David Au, MD    206-277-6132    dau@u.washington.edu   
Principal Investigator: David Au, MD         
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98101
Contact: Edmunds Udris    206-764-2504    ed.udris@va.gov   
Contact: Randall Curtis, MD, MPH    206-744-3356    jrc@u.washington.edu   
Principal Investigator: David Au, MD, MS         
Sub-Investigator: Randall Curtis, MD, MPH         
Sponsors and Collaborators
Centers for Medicare and Medicaid Services
Investigators
Study Chair: William C. Bailey, MD University of Alabama at Birmingham Lung Health Center
  More Information

Additional Information:
No publications provided

Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00692198     History of Changes
Other Study ID Numbers: 583, N01 HR76197
Study First Received: June 4, 2008
Last Updated: July 18, 2013
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
COPD

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 15, 2014