Oxygen Portable Concentrator During Exercises in Patients... | NCT00875719

Studies
Oxygen Portable Concentrator During Exercises in Patients With COPD

NCT00875719

Sponsor

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

Status

Completed

Last Update Posted

Feb 16, 2011Estimated

Enrollment

19Actual

Phase

Not Applicable

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Oxygen concentrators versus constant flow axygen
oxygen concentrator

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

Feb 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Jan 2011Actual

Completion Date

Feb 2011Actual

First Submitted Date

Mar 27, 2009

First Submission Date that Met QC Criteria

Apr 2, 2009

First Posted Date

Apr 3, 2009Estimated

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

Feb 15, 2011

Last Update Posted Date

Feb 16, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

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

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 differences in oxygen delivery between portable oxygen concentrators (POCs) and liquid oxygen (LOs) portable units, pose a question if POCs are equally effective as LOs in reducing exercise-induced hypoxaemia. DESIGN: Randomized, single-blind clinical trial.

Detailed Description

Our primary objective is to compare at rest and during exercise the evolution of oxygen saturation and dyspnea during 6 minutes walking test in patients with COPD receiving oxygen supplementation either with portable concentrators or liquid oxygen in a random order.

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

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
continuous v intermittent Oxygen therapy	Active Comparator	intermittent oxygen compared to constant flow oxygen as regards walking distance	Device: Oxygen concentrators versus constant flow axygen Device: oxygen concentrator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oxygen concentrators versus constant flow axygen	Device	Each patient performed 2 walking tests, and received oxygen supplementation from a portable concentrator or a liquid oxygen source, in a random order.

Measure	Description	Time Frame
Oxygen Saturation		One day

Measure	Description	Time Frame
Walking Distance		One day

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

COPD with respiratory failure and indication for oxygen supplementation at rest and/or during exercice.

Exclusion Criteria:

Evolutive heart disease.
Unability to understand or realize the tests.
Acute exacerbation during the last month.

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

Not provided

Overall Officials

Name	Affiliation	Role
Boris MELLONI, Pr	Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Pneumologie et Allergologie- Hôpital le Cluzeau. 23 av. D. Larrey		Limoges		87042	France

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided