Clinical trial NCT00325754: Benefits of Lightweight Ambulatory Oxygen Systems for Individuals With Chronic Obstructive Pulmonary Disease
Official title: Benefits of Ambulatory Oxygen in Hypoxemic COPD Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic Obstructive Pulmonary Disease
COPD
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Chronic Obstructive Pulmonary Disease Clinical Research Network
First posted: 2006-05-15
Enrollment: 22
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Individuals with COPD who experience hypoxemia (reduction of oxygen concentration in arterial blood) have an especially poor prognosis. Provision of LTOT to hypoxemic COPD patients is considered to be the standard of care. The majority of hypoxemic patients that are ambulatory are supplied with pressurized oxygen in E-cylinders. This system weighs approximately 22 pounds, is mounted on a wheeled cart, and is towed by the patient. These cumbersome systems can be seen to impose a significant burden on weak and debilitated patients, discouraging them from being active. E-cylinders towed on a cart are referred to as 'portable', in contrast to lightweight 'ambulatory' oxygen systems, which weigh less than 10 pounds and are designed to be carried by the patient. It is unknown whether patients provided with lightweight ambulatory systems comply better with oxygen prescription and increase their daily level of activity. This study will compare the use and benefits of a lightweight ambulatory oxygen device versus the standard portable E-cylinder device among hypoxemic individuals with COPD. Specifically, the study will examine daily duration of oxygen therapy and activity levels amongst both groups.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Stationary Oxygen Use Daily
timeFrame: 6 Months
measure: Ambulatory/Portable Oxygen Use Daily
timeFrame: 6 months
measure: Stationary Oxygen Use Daily
timeFrame: Baseline
Secondary outcomes:
measure: Average Mid-day Activity Monitoring at 3 Months
timeFrame: 3 Months
measure: Mid-day Activity Monitoring at 6 Months
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Torrance
country: United States
facility: Harbor-UCLA Research & Education Institution
state: California
city: Denver
country: United States
facility: Denver City-County Health/Hospitals Department
state: Colorado
city: Baltimore
country: United States
facility: University of Maryland Baltimore
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Minnesota Veterans Research Institute
state: Minnesota
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: Denver City-County Health/Hospitals Department
name: Richard K. Albert
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: William Bailey
role: PRINCIPAL_INVESTIGATOR
affiliation: Harbor-UCLA Research & Education Institution
name: Richard Casaburi
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: John Connett
role: PRINCIPAL_INVESTIGATOR
affiliation: Temple University
name: Gerard J. Criner
role: PRINCIPAL_INVESTIGATOR
affiliation: Univeristy of California at San Francisco
name: Stephen C. Lazarus
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Fernando J. Martinez
role: PRINCIPAL_INVESTIGATOR
affiliation: Minnesota Veterans Medical Research and Education Foundation
name: Dennis E. Niewoehner
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: John J. Reilly
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland, College Park
name: Steven M. Scharf
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Frank Sciurba
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.