NCT03174210

Brief Summary

The aim of this study is to investigate the effects of supplemental oxygen on blood oxygenation at rest in Patients with severe to very severe COPD comparing the portable oxygen concentrator (Activox™ 4L) to a liquid continuous oxygen device (Companion®).

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 not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable 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

May 2, 2017

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 30, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 2, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2017

Completed
Last Updated

February 15, 2018

Status Verified

February 1, 2018

Enrollment Period

5 months

First QC Date

May 30, 2017

Last Update Submit

February 14, 2018

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDsupplemental oxygenoxygen concentrator

Outcome Measures

Primary Outcomes (1)

  • Difference between LOD and POC in Partial pressure of oxygen levels

    PO2 values between LOD and POC at comparable Levels of oxygen supply (1liter/minute LOD will be compared to Level 1 of POC until 4liters/Minute LOD to Level 4 of POC)

    after 10 minutes of each LOD step compared to 10 minutes of each POC step

Secondary Outcomes (3)

  • Difference between LOD and POC in Partial pressure of carbon dioxide levels

    after 10 minutes of each LOD step compared to 10 minutes of each POC step

  • Change of partial pressure of Oxygen from one POC step to the next step

    after 10 minutes of one POC step compared to after 10 minutes of the next POC step

  • Change of partial pressure of carbon dioxide from one POC step to the next step

    after 10 minutes of one POC step compared to after 10 minutes of the next POC step

Study Arms (2)

COPD patients with delivery order 1, 2

EXPERIMENTAL

Patients will use two different Oxygen devices at rest (1.liquid oxygen device (Companion R), 2. portable Oxygen concentrator (Activox TM 4L))

Device: liquid oxygen device (LOD)Device: portable oxygen concentrator (POC)

COPD patients with delivery order 2,1

EXPERIMENTAL

Patients will use two different Oxygen devices at rest (1. portable Oxygen concentrator (Activox TM 4L), 2. liquid oxygen device (Companion R))

Device: liquid oxygen device (LOD)Device: portable oxygen concentrator (POC)

Interventions

liquid oxygen device (LOD)DEVICE

This oxygen Supplementation is used in special order

Also known as: Companion 1000 Chart Industries, Inc. Garfield Heights, USA
COPD patients with delivery order 1, 2COPD patients with delivery order 2,1
portable oxygen concentrator (POC)DEVICE

This oxygen Supplementation is used in special order

Also known as: Activox™ 4L, Inovalabs Inc., Texas, USA
COPD patients with delivery order 1, 2COPD patients with delivery order 2,1

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD patients with hypoxemia at rest (paO2 \< 55 or 60 mmHg, according to the recent supplemental oxygen guidelines \[Hadringe, M., et al., British Thoracic Society guidelines for home oxygen use in adults. Thorax, 2015. 70 Suppl 1: p. i1-43.\]
  • Participation in an inpatient pulmonary rehabilitation program (Schön Klinik BGL)
  • Written informed consent

You may not qualify if:

  • The Need of more than 4 Liter/min Oxygen at rest to achieve PaO2 \> 55 or 60mmHg
  • Signs of acute exacerbation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schoen Klinik Berchtesgadener Land

Schönau am Königssee, Germany

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

  • Klaus Kenn, Prof.

    Schoen Klinik Berchtesgadener Land

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: patients will be randomized into two different Groups (prospective cross-over design)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Klaus Kenn

Study Record Dates

First Submitted

May 30, 2017

First Posted

June 2, 2017

Study Start

May 2, 2017

Primary Completion

September 15, 2017

Study Completion

September 15, 2017

Last Updated

February 15, 2018

Record last verified: 2018-02

Locations

DE(1)