Status:
COMPLETED
Noninvasive Ventilation in ALS Patients With Mild Respiratory Involvement
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00386464
Start Date
April 1 2002
End Date
September 1 2007
Last Update
November 9 2007
Active Locations (1)
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1
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205