- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00386464
Noninvasive Ventilation in ALS Patients With Mild Respiratory Involvement
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21205
- Johns Hopkins University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Decline in forced vital capacity
|
Secondary Outcome Measures
Outcome Measure |
---|
quality of life
|
respiratory quality of life
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Noah Lechtzin, MD, Johns Hopkins University
- Study Chair: Charles M Wiener, MD, Johns Hopkins University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HL 67887-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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