Clinical trial NCT01926275: NPPV Added Inspiratory Muscle Training in Severe COPD
Official title: Noninvasive Positive Pressure Ventilation Added Inspiratory Muscle Training in Severe Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Hypercapnic Respiratory Failure
Keywords: COPD
Noninvasive Positive Pressure Ventilation
Respiratory Muscle Training
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
First posted: 2013-08-20
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine whether noninvasive positive pressure ventilation with inspiratory muscle training can improve quality of life and respiratory muscle strength than noninvasive positive pressure ventilation or inspiratory muscle training alone.


Eligibility criteria: Inclusion Criteria:

1. Aged 40-75 years, male or female.
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:

1. Smokers can be excluded;
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

Primary outcomes:
measure: Quality of life
timeFrame: Change from Baseline in quality of life at 8 weeks
Secondary outcomes:
measure: respiratory muscle strength
timeFrame: Change from Baseline in respiratory muscle strength at 8 weeks
measure: Dyspnea
timeFrame: Change from Baseline in dyspnea at 8 weeks
measure: Walked distance in 6MWT
timeFrame: Change from Baseline in walked distance at 8 weeks
measure: Frequency of acute exacerbations of COPD
timeFrame: 8 week
measure: Pulmonary function tests
timeFrame: Change from Baseline in pulmonary function tests at 8 weeks
measure: Blood gases levels
timeFrame: Change from Baseline in blood gases levelsat 8 weeks
measure: Sleep quality
timeFrame: Change from Baseline in sleep qualityat 8 weeks
measure: Length of hospital admission
timeFrame: 8 week
measure: frequency of of hospital admission
timeFrame: 8 week
Other outcomes:
Locations:
city: Canton
country: China
facility: Guangzhou Institute of Respiratory Disease
state: Guangdong
Study officials:
affiliation: Guangzhou Institute of Respiratory Disease
name: LuQian Zhou, Doctor
role: PRINCIPAL_INVESTIGATOR
References: