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

This study is currently recruiting participants.
Verified November 2017 by DELRIEU Jacqueline, Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
Sponsor:
ClinicalTrials.gov Identifier:
NCT01180803
First Posted: August 12, 2010
Last Update Posted: November 22, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
DELRIEU Jacqueline, Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
  Purpose
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 Intervention
LUNG DISEASES, OBSTRUCTIVE Device: pulse oxygen supplementation devices Device: continuous oxygen

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by DELRIEU Jacqueline, Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche:

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

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

Estimated Enrollment: 200
Study Start Date: July 2010
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
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
  Contacts and Locations
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
Contact: Boris MELLONI, Pr +33 1. 56. 81. 40. 60 melloni@unilim.fr

Locations
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
  More Information

Responsible Party: DELRIEU Jacqueline, Clinical Project Manager, Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
ClinicalTrials.gov Identifier: NCT01180803     History of Changes
Other Study ID Numbers: EVAL- CLIN A00690-39
First Submitted: August 11, 2010
First Posted: August 12, 2010
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:
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases