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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01180803
Other study ID # EVAL- CLIN A00690-39
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 2010
Est. completion date December 2023

Study information

Verified date March 2023
Source Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
Contact Boris MELLONI, Pr
Phone +33 1. 56. 81. 40. 60
Email melloni@unilim.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 2023
Est. primary completion date October 2023
Accepts healthy volunteers No
Gender All
Age group 45 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
pulse oxygen supplementation devices
oxygen therapy delivered by systems using oxygen-saving valves
continuous oxygen
oxygen therapy delivered by continuous liquid oxygen devices

Locations

Country Name City State
France Fédération ANTADIR Paris

Sponsors (1)

Lead Sponsor Collaborator
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary oxygen saturation during 6 minutes walking test 1 day
Secondary Walking distance during the 6 minutes walking test 1 day
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