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Noninvasive Ventilation in ALS Patients With Mild Respiratory Involvement

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00386464
First received: October 10, 2006
Last updated: November 8, 2007
Last verified: April 2007
History of Changes
  Purpose

Non-invasive ventilation or BiPAP®, which is a form of breathing support delivered through a facemask, is a successful treatment for the respiratory complications of amyotrophic lateral sclerosis (ALS). It has been shown to prolong survival, improve quality of life, and improve cognitive function. It is widely used among patients with ALS who have advanced breathing difficulties. It is not known whether there is benefit to using non-invasive ventilation earlier in the disease course.

There is evidence that non-invasive ventilation may slow down the decline in breathing function. If this were true then it would make sense to start non-invasive ventilation use earlier than the current clinically accepted practices.

The purpose of this study is to determine whether using non-invasive ventilation early in the course of disease can slow the decline in breathing function.

Patients remain in the study for 6 months and are asked to make 7 clinic visits during which time they will undergo pulmonary function tests and complete questionnaires.


Condition Intervention Phase
Amyotrophic Lateral Sclerosis
 Device: noninvasive positive pressure ventilation
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Noninvasive Ventilation in ALS Patients With Mild Respiratory Involvement

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Decline in forced vital capacity

Secondary Outcome Measures:
  • quality of life
  • respiratory quality of life

Estimated Enrollment: 60
Study Start Date: April 2002
Study Completion Date: September 2007
Detailed Description:

This is a randomized, crossover trial for patient with ALS and mild respiratory involvement. Patients with forced vital capacity above 60% of the predicted value can join. Patients will be assigned to either start using non-invasive ventilation at night or continue their usual care. After three months, patients will switch over to the other treatment group. For example, a patient who was initially assigned to continue their usual care would begin using non-invasive ventilation after three months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Probable or definite ALS by El Escorial criteria
  • age >17 years
  • FVC >60
  • minimal respiratory symptoms (no orthopnea or dyspnea at rest)
  • ability to provide informed consent

Exclusion Criteria:

  • Presence of another neurodegenerative disease
  • arterial CO2 above 45 mmHg
  • O2 below 60 mmHg
  • coexisting chronic lung disease unrelated to ALS
  • presence of an unstable medical condition such as coronary artery disease, liver failure, renal failure or cancer in the 30 days preceding enrollment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00386464

Locations
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Noah Lechtzin, MD Johns Hopkins University
Study Chair: Charles M Wiener, MD Johns Hopkins University
  More Information

Additional Information:
Johns Hopkins ALS Center  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00386464     History of Changes
Other Study ID Numbers: HL 67887-03
Study First Received: October 10, 2006
Last Updated: November 8, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
bipap
lou gehrigs disease
motor neuron disease
respiratory muscles

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Sclerosis
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
 Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013