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

NCT ID: NCT01180803

Last Updated: 2023-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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LUNG DISEASES, OBSTRUCTIVE

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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oxygen-saving valves

Group Type EXPERIMENTAL

pulse oxygen supplementation devices

Intervention Type DEVICE

oxygen therapy delivered by systems using oxygen-saving valves

continuous oxygen supplementation

Group Type ACTIVE_COMPARATOR

continuous oxygen

Intervention Type DEVICE

oxygen therapy delivered by continuous liquid oxygen devices

Interventions

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pulse oxygen supplementation devices

oxygen therapy delivered by systems using oxygen-saving valves

Intervention Type DEVICE

continuous oxygen

oxygen therapy delivered by continuous liquid oxygen devices

Intervention Type DEVICE

Other Intervention Names

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pulse group continuous group

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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DELRIEU Jacqueline

Clinical Project Manager

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fédération ANTADIR

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Boris MELLONI, Pr

Role: CONTACT

+33 1. 56. 81. 40. 60

Facility Contacts

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Jacqueline DELRIEU, Ph. D

Role: primary

+33.1.56.81.40.60

Other Identifiers

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EVAL- CLIN A00690-39

Identifier Type: -

Identifier Source: org_study_id

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