NCT00000571

Brief Summary

To test the effectiveness of ventilatory muscle rest (VMR) using home negative pressure ventilation (NPV) in improving exercise performance, alleviating dyspnea, and improving the quality of life in patients with severe chronic obstructive lung disease.

Trial Health

100
On Track

Trial Health Score

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

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

February 1, 1986

Completed
13.7 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

December 29, 2015

Status Verified

April 1, 2001

First QC Date

October 27, 1999

Last Update Submit

December 28, 2015

Conditions

Lung DiseasesLung Diseases, ObstructiveChronic Obstructive Pulmonary Disease

Interventions

ventilators, negative pressureDEVICE

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
No eligibility criteria

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (1)

  • Shapiro SH, Macklem PT, Gray-Donald K, Martin JG, Ernst PP, Wood-Dauphinee S, Hutchinson TA, Spitzer WO. A randomized clinical trial of negative pressure ventilation in severe chronic obstructive pulmonary disease: design and methods. J Clin Epidemiol. 1991;44(6):483-96. doi: 10.1016/0895-4356(91)90211-q.

    PMID: 2037853BACKGROUND

MeSH Terms

Conditions

Lung DiseasesLung Diseases, ObstructivePulmonary Disease, Chronic Obstructive

Interventions

Ventilators, Negative-Pressure

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ventilators, MechanicalEquipment and Supplies

Study Officials

  • Peter Macklem

    McGill University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

February 1, 1986

Last Updated

December 29, 2015

Record last verified: 2001-04