NCT00325754

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) affects over 14 million people in the United States. It is the fourth leading cause of death and the only leading cause of death for which mortality rates are rising. Medical science has developed few effective therapies for COPD. In patients with advanced COPD and chronic hypoxemia, long-term oxygen therapy (LTOT) has been shown to be uniquely beneficial. It is the only available non-surgical therapy demonstrated to prolong survival in these patients. This study will compare the clinical and physiologic benefits of two different oxygen therapy devices among hypoxemic individuals with COPD: a lightweight ambulatory oxygen device versus the standard portable E-cylinder device.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2005

Geographic Reach
1 country

10 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 15, 2006

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
10.2 years until next milestone

Results Posted

Study results publicly available

August 18, 2016

Completed
Last Updated

November 18, 2019

Status Verified

October 1, 2019

Enrollment Period

1.3 years

First QC Date

May 11, 2006

Results QC Date

May 20, 2016

Last Update Submit

October 30, 2019

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Chronic Obstructive Pulmonary DiseaseCOPD

Outcome Measures

Primary Outcomes (3)

  • Stationary Oxygen Use Daily

    6 Months

  • Ambulatory/Portable Oxygen Use Daily

    6 months

  • Stationary Oxygen Use Daily

    Baseline

Secondary Outcomes (2)

  • Average Mid-day Activity Monitoring at 3 Months

    3 Months

  • Mid-day Activity Monitoring at 6 Months

    6 months

Study Arms (2)

E-Cylinder

ACTIVE COMPARATOR

22-lb E-cylinder towed on a cart

Device: E-Cylinder

Lightweight Cylinder

ACTIVE COMPARATOR

3.6-lb lightweight cylinder that can be carried

Device: Lightweight Cylinder

Interventions

E-CylinderDEVICE

Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart

E-Cylinder
Lightweight CylinderDEVICE

Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder

Lightweight Cylinder

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Currently in a stable phase of COPD, defined as having had no disease exacerbation within the 4 weeks prior to study entry
  • Ambulatory
  • Forced expiratory volume in one second (FEV1) less than or equal to 60% of predicted value at screening
  • Ratio of FEV1 and forced vital capacity (FEV1/FVC) less than or equal to 65% of predicted value at screening
  • Currently receiving long-term oxygen therapy (LTOT)
  • Partial pressure of oxygen in arterial blood (PaO2) less than 60 torr

You may not qualify if:

  • Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, left-sided heart failure, peripheral vascular disease, exertional angina, complex arrhythmias, severe dependent edema, ischemic changes on stress electrocardiogram that would be contraindications for unrestricted ambulation or the 6-minute walk test)
  • Orthopedic impairments that would limit ambulation
  • Participation in the active phase of pulmonary rehabilitation within the 3 months prior to study entry
  • Neurologic impairments (e.g., Parkinson's disease or a stroke) or mental states (e.g., senile dementia) that would limit independent ambulation
  • Neoplastic disease that is anticipated to influence survival
  • Currently receiving lightweight ambulatory oxygen therapy
  • Inability to maintain an oxygen saturation of 92% at rest with 4 liter/minute of continuous oxygen flow and during exercise with an oxygen conserver setting of 6 utilizing a nasal cannula
  • Currently a smoker
  • Sleep apnea if it is characterized primarily as central sleep apnea syndrome (whether being treated or not) OR if it is known or suspected obstructive sleep apnea that has existed for at least 2 months and has not received stable treatment (stable treatment modes include positive airway pressure therapies or dental orthotic/mandibular positioning devices); individuals with diagnosed obstructive sleep apnea must have a body mass index less than or equal to 30 kg/m2 to be eligible for this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

University of California at San Francisco

San Francisco, California, 94143, United States

Location

Harbor-UCLA Research & Education Institution

Torrance, California, 90502, United States

Location

Denver City-County Health/Hospitals Department

Denver, Colorado, 80262, United States

Location

University of Maryland Baltimore

Baltimore, Maryland, 21201, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Minnesota Veterans Research Institute

Minneapolis, Minnesota, 55440, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (3)

  • Hecht A, Ma S, Porszasz J, Casaburi R; COPD Clinical Research Network. Methodology for using long-term accelerometry monitoring to describe daily activity patterns in COPD. COPD. 2009 Apr;6(2):121-9. doi: 10.1080/15412550902755044.

    PMID: 19378225RESULT

  • Casaburi R, Porszasz J, Hecht A, Tiep B, Albert RK, Anthonisen NR, Bailey WC, Connett JE, Cooper JA Jr, Criner GJ, Curtis J, Dransfield M, Lazarus SC, Make B, Martinez FJ, McEvoy C, Niewoehner DE, Reilly JJ, Scanlon P, Scharf SM, Sciurba FC, Woodruff P; COPD Clinical Research Network. Influence of lightweight ambulatory oxygen on oxygen use and activity patterns of COPD patients receiving long-term oxygen therapy. COPD. 2012 Feb;9(1):3-11. doi: 10.3109/15412555.2011.630048.

    PMID: 22292592RESULT

  • Kunisaki KM, Niewoehner DE, Connett JE; COPD Clinical Research Network. Vitamin D levels and risk of acute exacerbations of chronic obstructive pulmonary disease: a prospective cohort study. Am J Respir Crit Care Med. 2012 Feb 1;185(3):286-90. doi: 10.1164/rccm.201109-1644OC. Epub 2011 Nov 10.

    PMID: 22077070DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

The Data Safety and Monitoring Board requested termination of this study due to low recruitment. 22 participants were randomized out of a goal of 100.

Results Point of Contact

Title
Richard Casaburi
Organization
Harbo-UCLA Research and Education Institute
casaburi@ucla.edu
310-22-8249

Study Officials

  • Richard K. Albert

    Denver City-County Health/Hospitals Department

    PRINCIPAL INVESTIGATOR

  • William Bailey

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

  • Richard Casaburi

    Harbor-UCLA Research & Education Institution

    PRINCIPAL INVESTIGATOR

  • John Connett

    University of Minnesota

    PRINCIPAL INVESTIGATOR

  • Gerard J. Criner

    Temple University

    PRINCIPAL INVESTIGATOR

  • Stephen C. Lazarus

    Univeristy of California at San Francisco

    PRINCIPAL INVESTIGATOR

  • Fernando J. Martinez

    University of Michigan

    PRINCIPAL INVESTIGATOR

  • Dennis E. Niewoehner

    Minnesota Veterans Medical Research and Education Foundation

    PRINCIPAL INVESTIGATOR

  • John J. Reilly

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

  • Steven M. Scharf

    University of Maryland, College Park

    PRINCIPAL INVESTIGATOR

  • Frank Sciurba

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2006

First Posted

May 15, 2006

Study Start

March 1, 2005

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

November 18, 2019

Results First Posted

August 18, 2016

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

US(10)