NCT01180803

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 11, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2010

Completed
13.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

13.3 years

First QC Date

August 11, 2010

Last Update Submit

March 28, 2023

Conditions

LUNG DISEASES, OBSTRUCTIVE

Keywords

COPD - long term oxygenotherapyCOPD patients with respiratory failure

Outcome Measures

Primary Outcomes (1)

  • oxygen saturation during 6 minutes walking test

    1 day

Secondary Outcomes (1)

  • Walking distance during the 6 minutes walking test

    1 day

Study Arms (2)

oxygen-saving valves

EXPERIMENTAL
Device: pulse oxygen supplementation devices

continuous oxygen supplementation

ACTIVE COMPARATOR
Device: continuous oxygen

Interventions

pulse oxygen supplementation devicesDEVICE

oxygen therapy delivered by systems using oxygen-saving valves

Also known as: pulse group
oxygen-saving valves
continuous oxygenDEVICE

oxygen therapy delivered by continuous liquid oxygen devices

Also known as: continuous group
continuous oxygen supplementation

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD on necessity of long term oxygen therapy
  • Able to give their written consent

You may not qualify if:

  • Unstable patients with COPD
  • Patients with restrictive respiratory disease
  • Patients with cardiac or neurologic disease contre-indicating the different evaluations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fédération ANTADIR

Paris, 75006, France

RECRUITING

MeSH Terms

Conditions

Lung Diseases, Obstructive

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Central Study Contacts

Boris MELLONI, Pr

CONTACT

+33 1. 56. 81. 40. 60melloni@unilim.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Project Manager

Study Record Dates

First Submitted

August 11, 2010

First Posted

August 12, 2010

Study Start

July 1, 2010

Primary Completion

October 1, 2023

Study Completion

December 1, 2023

Last Updated

March 29, 2023

Record last verified: 2023-03

Locations

FR(1)