NCT00394225

Brief Summary

We assessed the effect of altering inspired gas on the 6MWT distance in COPD. We hypothesized that HeO2 would improve walking distance and reduce shortness of breath compared to both RA and O2, and potentially improve quality of life for COPD patients.

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 Jul 2005

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2006

Completed
Last Updated

October 31, 2006

Status Verified

October 1, 2006

First QC Date

October 30, 2006

Last Update Submit

October 30, 2006

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

6-Minute Walk TestCOPDHelium-HyperoxiaExerciseChronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

  • 6 minute walking distance

Secondary Outcomes (3)

  • shortness of breath

  • leg fatigue

  • arterial oxygen saturation

Interventions

OxygenDRUG
HeliumDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Exertional dyspnea
  • Activity limitation
  • COPD

You may not qualify if:

  • Recent exacerbation (\< 4 wks)
  • Supplemental O2
  • Significant cardiovascular/musculoskeletal abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edmonton General Hospital, Caritas Lung HEalth Centre

Edmonton, Alberta, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor Activity

Interventions

OxygenHelium

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGasesNoble Gases

Study Officials

  • Darcy D Marciniuk, MD, FRCP(C)

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 30, 2006

First Posted

October 31, 2006

Study Start

July 1, 2005

Study Completion

May 1, 2006

Last Updated

October 31, 2006

Record last verified: 2006-10

Locations

CA(1)