NCT01926275

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jul 2013

Shorter than P25 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 14, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 20, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

August 20, 2013

Status Verified

August 1, 2013

Enrollment Period

5 months

First QC Date

August 14, 2013

Last Update Submit

August 18, 2013

Conditions

Chronic Obstructive Pulmonary DiseaseHypercapnic Respiratory Failure

Keywords

COPDNoninvasive Positive Pressure VentilationRespiratory Muscle Training

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (9)

  • respiratory muscle strength

    Change from Baseline in respiratory muscle strength at 8 weeks

  • Dyspnea

    Change from Baseline in dyspnea at 8 weeks

  • Walked distance in 6MWT

    Change from Baseline in walked distance at 8 weeks

  • Frequency of acute exacerbations of COPD

    8 week

  • Pulmonary function tests

    Change from Baseline in pulmonary function tests at 8 weeks

  • +4 more secondary outcomes

Study Arms (4)

NPPV+IMT

EXPERIMENTAL

noninvasive positive pressure ventilation and inspiratory muscle training

Device: NPPVDevice: IMT

NPPV

ACTIVE COMPARATOR

noninvasive positive pressure ventilation

Device: NPPV+IMTDevice: IMT

IMT

ACTIVE COMPARATOR

inspiratory muscle training

Device: NPPV+IMTDevice: NPPV

LTOT

PLACEBO COMPARATOR

Long time oxygen therapy

Device: NPPV+IMTDevice: NPPVDevice: IMT

Interventions

NPPV+IMTDEVICE

noninvasive positive pressure ventilation and inspiratory muscle training

IMTLTOTNPPV
NPPVDEVICE

noninvasive positive pressure ventilation

IMTLTOTNPPV+IMT
IMTDEVICE

inspiratory muscle training

LTOTNPPVNPPV+IMT

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou Institute of Respiratory Disease

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveRespiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration Disorders

Study Officials

  • LuQian Zhou, Doctor

    Guangzhou Institute of Respiratory Disease

    PRINCIPAL INVESTIGATOR

Central Study Contacts

LuQian Zhou, Doctor

CONTACT

+86-15622236759zhlx09@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 14, 2013

First Posted

August 20, 2013

Study Start

July 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

August 20, 2013

Record last verified: 2013-08

Locations

CN(1)