NPPV Added Inspiratory Muscle Training in Severe COPD

Guangzhou Institute of Respiratory Disease

Status: Unknown

Conditions: Chronic Obstructive Pulmonary Disease; Hypercapnic Respiratory Failure

Treatments: Device: NPPV; Device: NPPV+IMT; Device: IMT

Study type: Interventional

Funder types: Other

Identifiers

NCT01926275

GZIRD-201308

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 4 patient groups, including a placebo group

NPPV+IMT

Experimental group

Description:

noninvasive positive pressure ventilation and inspiratory muscle training

Treatment:

Device: NPPV

Device: IMT

NPPV

Active Comparator group

Description:

noninvasive positive pressure ventilation

Treatment:

Device: IMT

Device: NPPV+IMT

IMT

Active Comparator group

Description:

inspiratory muscle training

Treatment:

Device: NPPV

Device: NPPV+IMT

LTOT

Placebo Comparator group

Description:

Long time oxygen therapy

Treatment:

Device: NPPV

Device: IMT

Device: NPPV+IMT