NPPV Added Inspiratory Muscle Training in Severe COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Noninvasive Positive Pressure Ventilation Added Inspiratory Muscle Training in Severe Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01926275
• Other study ID #: GZIRD-201308
• Status: Recruiting
• Phase: N/A
• First received: August 14, 2013
• Last updated: August 18, 2013
• Start date: July 2013
• Est. completion date: December 2013

Study information

• Verified date: August 2013
• Source: Guangzhou Institute of Respiratory Disease
• Contact: LuQian Zhou, Doctor
• Phone: +86-15622236759
• Email: zhlx09[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Hypercapnic Respiratory Failure
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Insufficiency

Intervention

Device:
• NPPV+IMT
noninvasive positive pressure ventilation and inspiratory muscle training
• NPPV
noninvasive positive pressure ventilation
• IMT
inspiratory muscle training

Locations

Country	Name	City	State
China	Guangzhou Institute of Respiratory Disease	Canton	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Institute of Respiratory Disease

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life	Severe Respiratory Insufficiency (SRI) Questionnaire and chronic obstructive pulmonary disease assessment test(CAT)	Change from Baseline in quality of life at 8 weeks	No
Secondary	respiratory muscle strength		Change from Baseline in respiratory muscle strength at 8 weeks	No
Secondary	Dyspnea	baseline dyspnea index (BDI)and transition dyspnea index(TDI)	Change from Baseline in dyspnea at 8 weeks	No
Secondary	Walked distance in 6MWT	Change from baseline in distance walked test 6-minute walk test at 8 week	Change from Baseline in walked distance at 8 weeks	No
Secondary	Frequency of acute exacerbations of COPD		8 week	No
Secondary	Pulmonary function tests		Change from Baseline in pulmonary function tests at 8 weeks	No
Secondary	Blood gases levels		Change from Baseline in blood gases levelsat 8 weeks	No
Secondary	Sleep quality	Epworth´s Sleepiness Scale	Change from Baseline in sleep qualityat 8 weeks	No
Secondary	Length of hospital admission		8 week	No
Secondary	frequency of of hospital admission		8 week	No