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NPPV Added Inspiratory Muscle Training in Severe COPD

Primary Purpose

Chronic Obstructive Pulmonary Disease, Hypercapnic Respiratory Failure

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

NPPV+IMT

NPPV

IMT

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Noninvasive Positive Pressure Ventilation, Respiratory Muscle Training

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Aged 40-75 years, male or female.
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.
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
No treatment with NPPV and respiratory muscle training in the last 8 weeks

Exclusion Criteria:

Smokers can be excluded;
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
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).
Local derangement of the face, skin, tongue, upper airways, larynx and upper oesophagus.
Severe chronic diseases except COPD, hindering the patient to follow the schedule of this study

Sites / Locations

Guangzhou Institute of Respiratory DiseaseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

NPPV+IMT

NPPV

IMT

LTOT

Arm Description

noninvasive positive pressure ventilation and inspiratory muscle training

noninvasive positive pressure ventilation

inspiratory muscle training

Long time oxygen therapy

Outcomes

Primary Outcome Measures

Quality of life

Severe Respiratory Insufficiency (SRI) Questionnaire and chronic obstructive pulmonary disease assessment test(CAT)

Secondary Outcome Measures

respiratory muscle strength

Dyspnea

baseline dyspnea index (BDI)and transition dyspnea index(TDI)

Walked distance in 6MWT

Change from baseline in distance walked test 6-minute walk test at 8 week

Frequency of acute exacerbations of COPD

Pulmonary function tests

Blood gases levels

Sleep quality

Epworth´s Sleepiness Scale

Length of hospital admission

frequency of of hospital admission

Full Information

NCT ID

NCT01926275

First Posted

August 14, 2013

Last Updated

August 18, 2013

Sponsor

Guangzhou Institute of Respiratory Disease

1. Study Identification

Unique Protocol Identification Number

NCT01926275

Brief Title

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

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Unknown status

Study Start Date

July 2013 (undefined)

Primary Completion Date

December 2013 (Anticipated)

Study Completion Date

December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guangzhou Institute of Respiratory Disease

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease, Hypercapnic Respiratory Failure

Keywords

COPD, Noninvasive Positive Pressure Ventilation, Respiratory Muscle Training

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

NPPV+IMT

Arm Type

Experimental

Arm Description

noninvasive positive pressure ventilation and inspiratory muscle training

Arm Title

NPPV

Arm Type

Active Comparator

Arm Description

noninvasive positive pressure ventilation

Arm Title

IMT

Arm Type

Active Comparator

Arm Description

inspiratory muscle training

Arm Title

LTOT

Arm Type

Placebo Comparator

Arm Description

Long time oxygen therapy

Intervention Type

Device

Intervention Name(s)

NPPV+IMT

Intervention Description

noninvasive positive pressure ventilation and inspiratory muscle training

Intervention Type

Device

Intervention Name(s)

NPPV

Intervention Description

noninvasive positive pressure ventilation

Intervention Type

Device

Intervention Name(s)

IMT

Intervention Description

inspiratory muscle training

Primary Outcome Measure Information:

Title

Quality of life

Description

Severe Respiratory Insufficiency (SRI) Questionnaire and chronic obstructive pulmonary disease assessment test(CAT)

Time Frame

Change from Baseline in quality of life at 8 weeks

Secondary Outcome Measure Information:

Title

respiratory muscle strength

Time Frame

Change from Baseline in respiratory muscle strength at 8 weeks

Title

Dyspnea

Description

baseline dyspnea index (BDI)and transition dyspnea index(TDI)

Time Frame

Change from Baseline in dyspnea at 8 weeks

Title

Walked distance in 6MWT

Description

Change from baseline in distance walked test 6-minute walk test at 8 week

Time Frame

Change from Baseline in walked distance at 8 weeks

Title

Frequency of acute exacerbations of COPD

Time Frame

8 week

Title

Pulmonary function tests

Time Frame

Change from Baseline in pulmonary function tests at 8 weeks

Title

Blood gases levels

Time Frame

Change from Baseline in blood gases levelsat 8 weeks

Title

Sleep quality

Description

Epworth´s Sleepiness Scale

Time Frame

Change from Baseline in sleep qualityat 8 weeks

Title

Length of hospital admission

Time Frame

8 week

Title

frequency of of hospital admission

Time Frame

8 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Aged 40-75 years, male or female. 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. 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 No treatment with NPPV and respiratory muscle training in the last 8 weeks Exclusion Criteria: Smokers can be excluded; 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 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). Local derangement of the face, skin, tongue, upper airways, larynx and upper oesophagus. Severe chronic diseases except COPD, hindering the patient to follow the schedule of this study

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

LuQian Zhou, Doctor

Phone

+86-15622236759

zhlx09@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

LuQian Zhou, Doctor

Organizational Affiliation

Guangzhou Institute of Respiratory Disease

Official's Role

Principal Investigator

Facility Information:

Facility Name

Guangzhou Institute of Respiratory Disease

City

Canton

State/Province

Guangdong

ZIP/Postal Code

510120

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

LuQian Zhou, Doctor

Phone

+86-15622236759

zhlx09@163.com

First Name & Middle Initial & Last Name & Degree

LuQian Zhou, Doctor

12. IPD Sharing Statement

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NPPV Added Inspiratory Muscle Training in Severe COPD

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