NCT02108925

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

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

Timeline
Completed

Started Apr 2014

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 23, 2018

Status Verified

March 1, 2018

Enrollment Period

1.9 years

First QC Date

April 7, 2014

Last Update Submit

March 21, 2018

Conditions

Chronic Obstructive Pulmonary DiseaseHypoxia

Outcome Measures

Primary Outcomes (1)

  • Pulmonary ventilation

    1 hour

Secondary Outcomes (3)

  • Dyspnoea

    1 hour

  • Heart rate

    1 hour

  • Blood pressure

    1 hour

Study Arms (1)

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

OxygenDRUG

supplementary oxygen during exercise

Supplementary oxygen

Eligibility Criteria

Age20 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic obstructive pulmonary disease

You may not qualify if:

  • No exacerbation
  • No active heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LHL-klinikkene Glittre

Hakadal, Akershus, 1485, Norway

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveHypoxia

Interventions

Oxygen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Officials

  • Anne Edvardsen, PhD

    LHL Helse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2014

First Posted

April 9, 2014

Study Start

April 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2018

Last Updated

March 23, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)