Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2013-07-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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NPPV+IMT
noninvasive positive pressure ventilation and inspiratory muscle training
NPPV
noninvasive positive pressure ventilation
IMT
inspiratory muscle training
NPPV
noninvasive positive pressure ventilation
NPPV+IMT
noninvasive positive pressure ventilation and inspiratory muscle training
IMT
inspiratory muscle training
IMT
inspiratory muscle training
NPPV+IMT
noninvasive positive pressure ventilation and inspiratory muscle training
NPPV
noninvasive positive pressure ventilation
LTOT
Long time oxygen therapy
NPPV+IMT
noninvasive positive pressure ventilation and inspiratory muscle training
NPPV
noninvasive positive pressure ventilation
IMT
inspiratory muscle training
Interventions
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NPPV+IMT
noninvasive positive pressure ventilation and inspiratory muscle training
NPPV
noninvasive positive pressure ventilation
IMT
inspiratory muscle training
Eligibility Criteria
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Inclusion Criteria
2. Have spirometric evidence of COPD with an FEV1 of \< 50% predicted and FEV1/FVC \< 0.70, measured within the last 6 months (GOLD stage III and IV). Stable disease since 4 weeks or more prior to randomisation.
3. PCO2 of 7 kPa, combined with a pH of 7.35 or above. These gases must be measured after 30 minutes breathing room air in sitting position
4. No treatment with NPPV and respiratory muscle training in the last 8 weeks
Exclusion Criteria
2. Diseases of the lung or thorax besides COPD: OSA Advanced pulmonary fibrosis, advanced bronchiectases, active tuberculosis, post tuberculosis syndrome, pneumonia, severe kyphoscoliosis, tracheostoma, neuromuscular diseases, or any other disorder, which might result in elevated PCO2
3. Body mass index of 35 kg/m² or above. Severe cardiac disease, NYHA IV, instable angina, severe cardiac arrhythmia, especially of ventricular origin (atrial fibrillation is not an exclusion criterion).
4. Local derangement of the face, skin, tongue, upper airways, larynx and upper oesophagus.
5. Severe chronic diseases except COPD, hindering the patient to follow the schedule of this study
40 Years
75 Years
ALL
No
Sponsors
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Guangzhou Institute of Respiratory Disease
OTHER
Responsible Party
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LuQian Zhou
Doctor
Principal Investigators
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LuQian Zhou, Doctor
Role: PRINCIPAL_INVESTIGATOR
Guangzhou Institute of Respiratory Disease
Locations
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Guangzhou Institute of Respiratory Disease
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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LuQian Zhou, Doctor
Role: primary
Other Identifiers
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GZIRD-201308
Identifier Type: -
Identifier Source: org_study_id