Trial of Portable Oxygen Cylinders Versus Battery Powered Portable Oxygen Concentrators

NCT01673685 | Completed DMC

• 1 other identifier: 2010090
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Randomised cross-over study of portable oxygen concentrators compared to oxygen cylinders to improve quality of life and other outcomes for patients with chronic obstructive pulmonary disease.

Conditions

COPD

Keywords

COPD; Oxygen cylinder; Portable oxygen cylinder; Battery powered delivery device; mobility; dyspnoea; Quality of Life; Cost effectiveness

Outcome Measures

Primary Outcomes (1)

• Quality of life as measured through Chronic Respiratory Questionnaire

  only two subdomains of the Chronic Respiratory Questionnaire (CRQ) were used: the Shortness of Breath (SoB) domain and the Mastery domain

  One month

Secondary Outcomes (3)

• Patient Preference

  One month

• Cost effectiveness of portable oxygen concentrator compared to cylinder

  one month

• Quality of life as measured through AQoL-8D

  One month

Study Arms (2)

Portable Oxygen Cylinder

PLACEBO COMPARATOR

Portable Oxygen Cylinder

Device: Portable Oxygen

Portable Oxygen Concentrator

ACTIVE COMPARATOR

Portable Oxygen Concentrator

Device: Portable Oxygen

Interventions

Portable Oxygen DEVICE

Also known as: Respironics Airsep (rental) AssetNumber 38269

Portable Oxygen Concentrator; Portable Oxygen Cylinder

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients diagnosed with stable COPD
• currently prescribed and using portable oxygen cylinders with a "pulsed" oxygen delivery for exertion.

You may not qualify if:

• Co-morbidities such as: other major respiratory conditions, cardiac or other substantial co-morbidities which significantly limit mobility independent of COPD
• Baseline step test which demonstrates a reduced effect on the battery device compared to oxygen cylinders.

Sponsors & Collaborators

• The Queen Elizabeth Hospital: lead

Study Sites (1)

The Queen Elizabeth Hospital

Woodville Road, Woodville, South Australia, 5022, Australia

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Brian J Smith, MBBS, FRACP, PhD

  The Queen Elizabeth Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Model Details: Portable oxygen concentrators vs oxygen cylinders

Study Record Dates

• First Submitted: August 15, 2012
• First Posted: August 28, 2012
• Study Start: October 1, 2010
• Primary Completion: July 1, 2016
• Study Completion: September 1, 2016
• Last Updated: April 10, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)