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

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ClinicalTrials.gov Identifier: NCT01180803
Recruitment Status : 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

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
U.S. FDA Resources

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 ]


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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

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

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 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:
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases