Effect of Short-term Oxygen During CPET in COPD | NCT03196089

Studies
Effect of Short-term Oxygen During CPET in COPD

NCT03196089

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Aug 13, 2019Actual

Enrollment

20Actual

Phase

Phase 2

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Oxygen application

Countries

Switzerland

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

Aug 2019

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

Jun 2, 2017Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Jun 20, 2017

First Submission Date that Met QC Criteria

Jun 20, 2017

First Posted Date

Jun 22, 2017Actual

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

Aug 12, 2019

Last Update Posted Date

Aug 13, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

In a randomized, sham-controlled trial the investigators will test whether supplemental oxygen given during cardiopulmonary exercise testing will improve exercise performance and physiological parameters in patients with chronic obstructive pulmonary disease.

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Supplemental oxygen	Experimental	Supplemental oxygen will be applied via a mask during CPET	Procedure: Oxygen application
Sham room air	Sham Comparator	Room air will be applied similarly to oxygen	Procedure: Oxygen application

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oxygen application	Procedure	Supplemental oxygen via mask	Sham room air Supplemental oxygen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Watt		1 day
Exercise time		1 day

Secondary Outcomes

Measure	Description	Time Frame
Peak Oxygen uptake		1 day
Respiratory Exchange ratio		1 day
Ventilatory equivalent of carbon dioxide (VE/VCO2) slope

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosis of chronic obstructive pulmonary disease
on optimized medical therapy and in stable condition for at least 4 week
desaturate in the 6 minute walking test by at least 4% to values <92%

Exclusion Criteria:

unstable conditions
pregnant women
patients with relevant concomitant lung disease and severe daytime hypoxemia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 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
Silvia Ulrich Somaini, Prof. Dr.	University Hospital Zurich, Division of Pneumology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Zurich, Division of Pneumology		Zurich		8091	Switzerland

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

Ancestor Terms

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

Browse Leaves

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Browse Branches

Not provided