NCT03196089

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jun 2017

Typical duration for phase_2 chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 2, 2017

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

August 13, 2019

Status Verified

August 1, 2019

Enrollment Period

1.6 years

First QC Date

June 20, 2017

Last Update Submit

August 12, 2019

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

  • Watt

    1 day

  • Exercise time

    1 day

Secondary Outcomes (5)

  • Peak Oxygen uptake

    1 day

  • Respiratory Exchange ratio

    1 day

  • Ventilatory equivalent of carbon dioxide (VE/VCO2) slope

    1 day

  • End-tidal pressures of carbon dioxide (PET CO2)

    1 day

  • Changes in arterial blood parameters

    1 day

Study Arms (2)

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

Oxygen applicationPROCEDURE

Supplemental oxygen via mask

Sham room airSupplemental oxygen

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Division of Pneumology

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Silvia Ulrich Somaini, Prof. Dr.

    University Hospital Zurich, Division of Pneumology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2017

First Posted

June 22, 2017

Study Start

June 2, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

August 13, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)