NCT00546299

Brief Summary

Several studies have described the use of supplemental oxygen during exertion or activities of daily living (ambulatory oxygen) in study populations that have different characteristics. This report, based on specialized randomized controlled trials, characterizes ambulatory gas usage among patients with COPD who experience low oxygen levels during activities.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Feb 2003

Typical duration for not_applicable chronic-obstructive-pulmonary-disease

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

February 1, 2003

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 18, 2007

Completed
Last Updated

April 30, 2024

Status Verified

October 1, 2007

First QC Date

October 17, 2007

Last Update Submit

April 26, 2024

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Ambulatory oxygen therapyCOPDexertional hypoxemia

Outcome Measures

Primary Outcomes (1)

  • gas usage

    2

Interventions

oxygenDRUG

cylinder and concentrator, dosage to maintain SpO2 above 92%, used during exertion

Eligibility Criteria

AgeUp to 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of COPD
  • dyspnea limiting daily activities
  • desaturation less than or equal to 88% for 2 continuous minutes during a room air six-minute walk test

You may not qualify if:

  • less than or equal to 18 years old
  • those who met criteria for mortality reduction with long-term oxygen
  • those who received oxygen for palliative care or isolated nocturnal hypoxemia
  • those unable to complete the questionnaires or provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Oxygen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Officials

  • Roger Goldstein, MD

    Respiratory Rehabilitation, West Park Healthcare Centre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 17, 2007

First Posted

October 18, 2007

Study Start

February 1, 2003

Study Completion

December 1, 2005

Last Updated

April 30, 2024

Record last verified: 2007-10