Effect of Oxygen Supplementation During Exercise in Chron... | NCT02108925

Studies
Effect of Oxygen Supplementation During Exercise in Chronic Obstructive Pulmonary Disease Patients

NCT02108925

Sponsor

LHL Helse

Status

Completed

Last Update Posted

Mar 23, 2018Actual

Enrollment

16Actual

Phase

Not Applicable

Conditions

Chronic Obstructive Pulmonary Disease
Hypoxia

Interventions

Oxygen

Countries

Norway

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 2018

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

Apr 2014

Primary Completion Date

Mar 2016Actual

Completion Date

Mar 2018Actual

First Submitted Date

Apr 7, 2014

First Submission Date that Met QC Criteria

Apr 8, 2014

First Posted Date

Apr 9, 2014Estimated

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 21, 2018

Last Update Posted Date

Mar 23, 2018Actual

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 project will test the hypothesis that lung ventilation during exercise is unaffected by oxygen supplementation. In addition, the acute effect of oxygen supplementation on dyspnoea, heart rate and blood pressure will be studied.

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

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Supplementary oxygen	Experimental	Study subjects receive, in randomized order, either supplementary 30% oxygen or air (21% Oxygen) from a gas tight bag	Drug: Oxygen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oxygen	Drug	supplementary oxygen during exercise	Supplementary oxygen

Measure	Description	Time Frame
Pulmonary ventilation		1 hour

Measure	Description	Time Frame
Dyspnoea		1 hour
Heart rate		1 hour
Blood pressure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Chronic obstructive pulmonary disease

Exclusion Criteria:

No exacerbation
No active heart disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

95 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
Anne Edvardsen, PhD	LHL Helse	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
LHL-klinikkene Glittre		Hakadal	Akershus	1485	Norway

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D000860	Hypoxia

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

Intervention Browse Module

MeSH Terms

ID	Term
D010100	Oxygen

Ancestor Terms

ID	Term
D018011	Chalcogens
D004602	Elements
D007287	Inorganic Chemicals
D005740	Gases

Browse Leaves

Not provided

Browse Branches

Not provided