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Efficacy of Oxygen Therapy Delivered by Systems Using Oxygen-Saving Valves in COPD Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01180803
Recruitment Status : Unknown
Verified November 2017 by DELRIEU Jacqueline, Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche.
Recruitment status was:  Recruiting
First Posted : August 12, 2010
Last Update Posted : November 22, 2017
Sponsor:
Information provided by (Responsible Party):
DELRIEU Jacqueline, Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

Brief Summary:
The purpose of this study is to compare the efficacy of oxygen therapy delivered by systems using oxygen-saving valves or not (continuous oxygen). We aim to determine if systems using oxygen-saving valves are equally effective as continuous oxygen delivery systems in reducing exercise-induced hypoxemia in patients with COPD.

Condition or disease Intervention/treatment Phase
LUNG DISEASES, OBSTRUCTIVE Device: pulse oxygen supplementation devices Device: continuous oxygen Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 2010
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: oxygen-saving valves Device: pulse oxygen supplementation devices
oxygen therapy delivered by systems using oxygen-saving valves
Other Name: pulse group

Active Comparator: continuous oxygen supplementation Device: continuous oxygen
oxygen therapy delivered by continuous liquid oxygen devices
Other Name: continuous group




Primary Outcome Measures :
  1. oxygen saturation during 6 minutes walking test [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Walking distance during the 6 minutes walking test [ Time Frame: 1 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • COPD on necessity of long term oxygen therapy
  • Able to give their written consent

Exclusion Criteria:

  • Unstable patients with COPD
  • Patients with restrictive respiratory disease
  • Patients with cardiac or neurologic disease contre-indicating the different evaluations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01180803


Contacts
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Contact: Boris MELLONI, Pr +33 1. 56. 81. 40. 60 melloni@unilim.fr

Locations
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France
Fédération ANTADIR Recruiting
Paris, France, 75006
Contact: Jacqueline DELRIEU, Ph. D    +33.1.56.81.40.60    delrieu@antadir.com   
Principal Investigator: Boris MELLONI, Pr         
Sponsors and Collaborators
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
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Responsible Party: DELRIEU Jacqueline, Clinical Project Manager, Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
ClinicalTrials.gov Identifier: NCT01180803    
Other Study ID Numbers: EVAL- CLIN A00690-39
First Posted: August 12, 2010    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017
Keywords provided by DELRIEU Jacqueline, Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche:
COPD - long term oxygenotherapy
COPD patients with respiratory failure
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases