Noninvasive Ventilation in ALS Patients With Mild Respiratory Involvement
Completed · Phase 2/Phase 3
Conditions studied: Amyotrophic Lateral Sclerosis
In brief
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.
Key facts
- Study ID
- NCT00386464
- Run by
- Johns Hopkins University
- People needed
- 60
- Starts
- 2002-04-01
- Expected to finish
- 2007-09-01
- Last updated by the study team
- 2007-11-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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