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

Sponsor
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche (Other)
Overall Status
Unknown status
CT.gov ID
NCT01180803
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
101
Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: pulse oxygen supplementation devices
  • Device: continuous oxygen
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Jul 1, 2010
Anticipated Primary Completion Date :
Sep 1, 2018
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: oxygen-saving valves

Device: pulse oxygen supplementation devices
oxygen therapy delivered by systems using oxygen-saving valves
Other Names:
  • pulse group

    		•
    Active Comparator: continuous oxygen supplementation

    Device: continuous oxygen
    oxygen therapy delivered by continuous liquid oxygen devices
    Other Names:
  • continuous group

    		•

    Outcome Measures

    Primary Outcome Measures

    1. oxygen saturation during 6 minutes walking test [1 day]

    Secondary Outcome Measures

    1. Walking distance during the 6 minutes walking test [1 day]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Fédération ANTADIR Paris France 75006

    Sponsors and Collaborators

    • Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Aug 12, 2010
    Last Update Posted:
    Nov 22, 2017
    Last Verified:
    Nov 1, 2017
    Keywords provided by DELRIEU Jacqueline, Clinical Project Manager, 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

    Study Results

    No Results Posted as of Nov 22, 2017