Oxygen Portable Concentrator During Exercises in Patients With COPD

This study is currently recruiting participants.

Verified by Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire, April 2009

First Received: March 27, 2009 Last Updated: April 9, 2009 History of Changes

Sponsored by:	Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire
Information provided by:	Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire
ClinicalTrials.gov Identifier:	NCT00875719

Purpose

The purpose of this study is to compare differences in oxygen delivery between portable oxygen concentrators (POCs) and liquid oxygen (LOs) portable units, pose a question if POCs are equally effective as LOs in reducing exercise-induced hypoxaemia. DESIGN: Randomized, single-blind clinical trial.

Condition	Intervention
Chronic Obstructive Pulmonary Disease	Device: Oxygen supplementation

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Dietary Supplements Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Comparing Effectiveness of Oxygen Supplementation From a Portable Concentrator and a Liquid Oxygen Source During Walking Test in COPD Patients With Respiratory Failure

Further study details as provided by Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire:

Primary Outcome Measures:

Oxygen Saturation [ Time Frame: One day ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Walking Distance [ Time Frame: One day ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	February 2009
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Each patient performed 2 walking tests, and received oxygen supplementation from a portable concentrator or a liquid oxygen source, in a random order.

Detailed Description:

Our primary objective is to compare at rest and during exercise the evolution of oxygen saturation and dyspnea during 6 minutes walking test in patients with COPD receiving oxygen supplementation either with portable concentrators or liquid oxygen in a random order.

Eligibility

Ages Eligible for Study:	45 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

COPD with respiratory failure and indication for oxygen supplementation at rest and/or during exercice.

Exclusion Criteria:

Evolutive heart disease.
Unability to understand or realize the tests.
Acute exacerbation during the last month.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00875719

Contacts

Contact: Boris MELLONI, Pr

05. 55. 05. 68.81

boris.melloni@unilim.fr

Locations

France
Service de Pneumologie et Allergologie- Hôpital le Cluzeau. 23 av. D. Larrey	Recruiting
LIMOGES cedex, France, 87042
Contact: Boris MELLONI, Pr 05. 55. 05. 68.81 boris.melloni@unilim.fr

Sponsors and Collaborators

Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire

Investigators

Principal Investigator:

Boris MELLONI, Pr

Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire

More Information

No publications provided

Responsible Party:	ANTADIR ( Jean François MUIR - President )
Study ID Numbers:	ANTADIR CMTS OXYGEN 2009
Study First Received:	March 27, 2009
Last Updated:	April 9, 2009
ClinicalTrials.gov Identifier:	NCT00875719 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire:

COPD patients with respiratory failure

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Insufficiency
Respiratory Tract Diseases

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Lung Diseases, Obstructive
Respiratory Insufficiency
Respiratory Tract Diseases

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on May 07, 2009