Status:
UNKNOWN
The Additional Value of Noninvasive Ventilation Next to Rehabilitation in Hypercapnic COPD Patients
Lead Sponsor:
Groningen Research Institute for Asthma and COPD
Collaborating Sponsors:
The Netherlands Asthma Foundation
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to investigate whether noninvasive ventilation by nose mask during the night has additional benefits next to pulmonary rehabilitation in patients with severe hypercapnic C...
Detailed Description
Several randomised controlled trials in patients with stable Chronic Obstructive Pulmonary Disease (COPD) have demonstrated that pulmonary rehabilitation (PR) improves dyspnoea, exercise tolerance, an...
Eligibility Criteria
Inclusion
- COPD (FEV1\< 50%, Tiffeneau \< 70%)
- Dyspnoea on exertion and a reduced exercise capacity
- Age 75 years or less
- PaCO2 \> 6.0 kPa at rest without oxygen
Exclusion
- Cardial/neuromuscular diseases limiting a successful rehabilitation
- Obstructive sleep apnoea syndrome: apnea/hypopnea index (AHI) \> 10
- Previous exposure to chronic NIPPV
- Participation in a pulmonary rehabilitation program less than 18 months ago
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
April 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00135538
Start Date
November 1 2004
End Date
April 1 2009
Last Update
April 5 2007
Active Locations (1)
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1
University medical Hospital Groningen
Groningen, Provincie Groningen, Netherlands, 9700 RB