Chronic Obstructive Pulmonary DiseaseNCT01926275
NPPV Added Inspiratory Muscle Training in Severe COPD
A study testing NPPV+IMT, NPPV and IMT in people with Chronic Obstructive Pulmonary Disease and Hypercapnic Respiratory Failure, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Hypercapnic Respiratory Failure
- What is being tested?
- NPPV+IMT, NPPV and IMT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jul 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou Institute of Respiratory Disease
Guangzhou, Guangdong, 510120
LuQian Zhou, Doctor, +86-15622236759, zhlx09@163.com
LuQian Zhou, Doctor
About this study
Official title: Noninvasive Positive Pressure Ventilation Added Inspiratory Muscle Training in Severe Chronic Obstructive Pulmonary Disease
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.
- Being tested
- NPPV+IMT, NPPV, IMT
- Keywords
- COPD, Noninvasive Positive Pressure Ventilation, Respiratory Muscle Training
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPPV+IMTDevice
noninvasive positive pressure ventilation and inspiratory muscle training
NPPVDevice
noninvasive positive pressure ventilation
IMTDevice
inspiratory muscle training
| Study group | Role | What they receive |
|---|---|---|
| NPPV+IMT | Experimental | noninvasive positive pressure ventilation and inspiratory muscle training Receives: Device: NPPV; Device: IMT |
| NPPV | Active comparator | noninvasive positive pressure ventilation Receives: Device: NPPV+IMT; Device: IMT |
| IMT | Active comparator | inspiratory muscle training Receives: Device: NPPV+IMT; Device: NPPV |
| LTOT | Placebo comparator | Long time oxygen therapy Receives: Device: NPPV+IMT; Device: NPPV; Device: IMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Severe Respiratory Insufficiency (SRI) Questionnaire and chronic obstructive pulmonary disease assessment test(CAT)
Measured: Change from Baseline in quality of life at 8 weeks
Secondary outcomes (9)
respiratory muscle strength
Measured: Change from Baseline in respiratory muscle strength at 8 weeks
Dyspnea
baseline dyspnea index (BDI)and transition dyspnea index(TDI)
Measured: Change from Baseline in dyspnea at 8 weeks
Walked distance in 6MWT
Change from baseline in distance walked test 6-minute walk test at 8 week
Measured: Change from Baseline in walked distance at 8 weeks
Frequency of acute exacerbations of COPD
Measured: 8 week
Pulmonary function tests
Measured: Change from Baseline in pulmonary function tests at 8 weeks
Blood gases levels
Measured: Change from Baseline in blood gases levelsat 8 weeks
Sleep quality
Epworth´s Sleepiness Scale
Measured: Change from Baseline in sleep qualityat 8 weeks
Length of hospital admission
Measured: 8 week
frequency of of hospital admission
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LuQian Zhou, Guangzhou Institute of Respiratory Disease
- Investigators
- LuQian Zhou, Doctor, Principal investigator, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926275
- Sponsor's protocol ID
- GZIRD-201308
- Status last verified
- Aug 2013
- First submitted
- 14 Aug 2013
- Last updated
- 20 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Positive Pressure Ventilation Added Inspiratory Muscle Training in Severe Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01926275
- Acronym / sponsor ID
- GZIRD-201308
- Keywords
- COPD, Noninvasive Positive Pressure Ventilation, Respiratory Muscle Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 20 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NPPV+IMT | Experimental | Device: NPPV, Device: IMTnoninvasive positive pressure ventilation and inspiratory muscle training |
| NPPV | Active comparator | Device: NPPV+IMT, Device: IMTnoninvasive positive pressure ventilation |
| IMT | Active comparator | Device: NPPV+IMT, Device: NPPVinspiratory muscle training |
| LTOT | Placebo comparator | Device: NPPV+IMT, Device: NPPV, Device: IMTLong time oxygen therapy |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NPPV+IMTnoninvasive positive pressure ventilation and inspiratory muscle training | Device | IMT, LTOT, NPPV |
| NPPVnoninvasive positive pressure ventilation | Device | IMT, LTOT, NPPV+IMT |
| IMTinspiratory muscle training | Device | LTOT, NPPV, NPPV+IMT |
Primary outcome
Quality of life
Time frame: Change from Baseline in quality of life at 8 weeks
Severe Respiratory Insufficiency (SRI) Questionnaire and chronic obstructive pulmonary disease assessment test(CAT)
9 secondary outcomes
respiratory muscle strength
Time frame: Change from Baseline in respiratory muscle strength at 8 weeks
Dyspnea
Time frame: Change from Baseline in dyspnea at 8 weeks
Walked distance in 6MWT
Time frame: Change from Baseline in walked distance at 8 weeks
Frequency of acute exacerbations of COPD
Time frame: 8 week
Pulmonary function tests
Time frame: Change from Baseline in pulmonary function tests at 8 weeks
Blood gases levels
Time frame: Change from Baseline in blood gases levelsat 8 weeks
Sleep quality
Time frame: Change from Baseline in sleep qualityat 8 weeks
Length of hospital admission
Time frame: 8 week
frequency of of hospital admission
Time frame: 8 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LuQian Zhou, Doctor principal investigator
Guangzhou Institute of Respiratory Disease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NPPV+IMT, NPPV and IMT in people with Chronic Obstructive Pulmonary Disease and Hypercapnic Respiratory Failure, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LuQian Zhou, Doctor (+86-15622236759, zhlx09@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: Change from Baseline in quality of life at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2013.