Efficacy of Oxygen Therapy Delivered by Systems Using Oxy... | NCT01180803

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

NCT01180803

Sponsor

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

Status

Unknown status

Last Update Posted

Mar 29, 2023Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

LUNG DISEASES, OBSTRUCTIVE

Interventions

pulse oxygen supplementation devices
continuous oxygen

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Oct 2023Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Aug 11, 2010

First Submission Date that Met QC Criteria

Aug 11, 2010

First Posted Date

Aug 12, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2023

Last Update Posted Date

Mar 29, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

DELRIEU Jacqueline, Clinical Project Manager, Association Nationale pour les Traitements A Domicile, les Innovations et la RecherchePrincipal Investigator

Lead Sponsor

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

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
oxygen-saving valves	Experimental		Device: pulse oxygen supplementation devices
continuous oxygen supplementation	Active Comparator		Device: continuous oxygen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pulse oxygen supplementation devices	Device	oxygen therapy delivered by systems using oxygen-saving valves	oxygen-saving valves

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
oxygen saturation during 6 minutes walking test		1 day

Secondary Outcomes

Measure	Description	Time Frame
Walking distance during the 6 minutes walking test		1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Boris MELLONI, Pr	Contact	+33 1. 56. 81. 40. 60		melloni@unilim.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fédération ANTADIR	Recruiting	Paris		75006	France

Condition Browse Module

MeSH Terms

ID	Term
D008173	Lung Diseases, Obstructive

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided