Chronic Obstructive Pulmonary DiseaseNCT02012101
Non-invasive Mechanical Ventilation as a Rescue Therapy to Relieve Dyspnea in Patients With Stable Severe COPD
A study testing niv plus oxygen therapy and oxygen therapy in people with Chronic Obstructive Pulmonary Disease, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial summary
The purpose of this study is to determine whether non-invasive mechanical ventilation(NIV), playing the role as a rescue therapy , are effective in relieving exertional dyspnea in stable severe COPD patients. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- niv plus oxygen therapy and oxygen therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- Mar 2013to Apr 2014
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- severe COPD (post bronchodilator FEV1/FVC < 70% and FEV1 < 50% predicted)
- stable clinical condition(no exacerbation in the 4 weeks prior to study participation with no change in medications)
- dyspnea as a main symptom that limited daily activities
Who cannot join
- obvious pulmonary bullae demonstrated by chest CT scan or X-ray examination
- facial trauma/malformation; recent facial, upper airway or upper gastrointestinal tract surgery
- oxygen saturation(SpO2) < 88% at rest with a fraction of inspired oxygen(FiO2) ≥ 0.5
- systolic blood pressure > 160mmHg or diastolic blood pressure > 100mmHg at rest
- unstable angina or a myocardial infarct in the previous four weeks
- resting sinus tachycardia ( > 120 beats/min)
- patients with musculoskeletal or neurological disorders
- patients who are unable to give informed consent
Trial locations and contacts
1 site in 1 country.
China1 site
State Key Laboratory of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, 510120
About this study
Official title: The Efficacy of Non-invasive Mechanical Ventilation as a Rescue Therapy for Relieving Dyspnea in Patients With Stable Severe COPD
The purpose of this study is to determine whether non-invasive mechanical ventilation(NIV), playing the role as a rescue therapy , are effective in relieving exertional dyspnea in stable severe COPD patients.
Read the detailed description
Chronic obstructive pulmonary disease(COPD) is a preventable and treatable illness, which is clinically characterized by persistent airflow limitation that is usually progressive. It's well known that airflow limitation lead to air trapping particularly during exercise, resulting in increased dyspnea and limitation of exercise capacity. Thus, COPD patients often unconsciously adopt a sedentary lifestyle, probably due to distressing exertional dyspnea. The sedentarism results in physical deconditioning and alterations of the peripheral muscles, and the latter one causes more exertional dyspnea and fatigue, which in turn leads to much more sedentarism, forming the vicious cycle of sedentarism, dyspnea/fatigue and more sedentarism. Thereby, measures should be taken to interrupt this vicious cycle. Some previous studies suggested that niv acting as an add-on therapy could help unloading the inspiratory muscle, reducing the dynamic compression of the airway, diminishing the dynamic hyperinflation,to some extent, relieved dyspnea during exercise in COPD patients. However,those measures were taken during exercise, acting as an add-on therapy. Whether NIV can play a role as a rescue therapy to relieve exertional dyspnea while the patients are already undergoing optimal treatment with bronchodilator and anti-inflammatory medication is still not quite clear. Therefore, we hypothesize that niv as a rescue-therapy has the same effect on relieving dyspnea in stable severe COPD patients just like the add-on therapy.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- niv plus oxygen therapy, oxygen therapy
- Keywords
- COPD, dyspnea, exercise, Noninvasive Ventilation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
niv plus oxygen therapyDevice
Also called Philips Respironics BiPAP Vision
NIV given on Philips Respironics BiPAP Vision apparatus.
oxygen therapyDevice
| Study group | Role | What they receive |
|---|---|---|
| niv plus oxygen therapy | Experimental | oxygen therapy is given during the whole experimental process, niv is given at peak exercise until the borg scale reaches it's baseline point Receives: Device: niv plus oxygen therapy |
| oxygen therapy | Active comparator | oxygen therapy is given during the whole experimental process Receives: Device: oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Borg scale
Measured: baseline,repeated measurement for about ten minutes after intervention
Secondary outcomes (7)
Inspiratory capacity(IC)
Measured: baseline,repeated measurement for about ten minutes after intervention
surface electromyography(sEMG)
Measured: baseline,repeated measurement for about ten minutes after intervention
respiratory parameters
minute ventilation(VE); tidal volume(Vt); respiratory rate(RR); inspiratory time(Ti); total duty cycle(Ttot)
Measured: baseline,repeated measurement for about ten minutes after intervention
oxygen saturation(SpO2)
Measured: baseline,repeated measurement for about ten minutes after intervention
Heart Rate(HR)
Measured: baseline,repeated measurement for about ten minutes after intervention
the total recovery time
Measured: repeated measurement for about ten minutes after intervention
mouth pressure(Pmo)
Measured: baseline,repeated measurement for about ten minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startMar 2013
- Primary completionApr 2014
- Study completionApr 2014
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yonger Ou, Guangzhou Institute of Respiratory Disease
- Investigators
- Rongchang Chen, M.D., Principal investigator, Sate Key Laboratory of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012101
- Sponsor's protocol ID
- 2009CB522111
- Status last verified
- Jun 2014
- First submitted
- 8 Dec 2013
- Last updated
- 24 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Non-invasive Mechanical Ventilation as a Rescue Therapy for Relieving Dyspnea in Patients With Stable Severe COPD
- ClinicalTrials.gov ID
- NCT02012101
- Acronym / sponsor ID
- 2009CB522111
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, dyspnea, exercise, Noninvasive Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 16 Dec 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 purpose of this study is to determine whether non-invasive mechanical ventilation(NIV), playing the role as a rescue therapy , are effective in relieving exertional dyspnea in stable severe COPD patients.
Detailed description
Chronic obstructive pulmonary disease(COPD) is a preventable and treatable illness, which is clinically characterized by persistent airflow limitation that is usually progressive. It's well known that airflow limitation lead to air trapping particularly during exercise, resulting in increased dyspnea and limitation of exercise capacity. Thus, COPD patients often unconsciously adopt a sedentary lifestyle, probably due to distressing exertional dyspnea. The sedentarism results in physical deconditioning and alterations of the peripheral muscles, and the latter one causes more exertional dyspnea and fatigue, which in turn leads to much more sedentarism, forming the vicious cycle of sedentarism, dyspnea/fatigue and more sedentarism. Thereby, measures should be taken to interrupt this vicious cycle. Some previous studies suggested that niv acting as an add-on therapy could help unloading the inspiratory muscle, reducing the dynamic compression of the airway, diminishing the dynamic hyperinflation,to some extent, relieved dyspnea during exercise in COPD patients. However,those measures were taken during exercise, acting as an add-on therapy. Whether NIV can play a role as a rescue therapy to relieve exertional dyspnea while the patients are already undergoing optimal treatment with bronchodilator and anti-inflammatory medication is still not quite clear. Therefore, we hypothesize that niv as a rescue-therapy has the same effect on relieving dyspnea in stable severe COPD patients just like the add-on therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| niv plus oxygen therapy | Experimental | Device: niv plus oxygen therapyoxygen therapy is given during the whole experimental process, niv is given at peak exercise until the borg scale reaches it's baseline point |
| oxygen therapy | Active comparator | Device: oxygen therapyoxygen therapy is given during the whole experimental process |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- severe COPD (post bronchodilator FEV1/FVC < 70% and FEV1 < 50% predicted)
- stable clinical condition(no exacerbation in the 4 weeks prior to study participation with no change in medications)
- dyspnea as a main symptom that limited daily activities
Key exclusion criteria (8 listed)
- obvious pulmonary bullae demonstrated by chest CT scan or X-ray examination
- facial trauma/malformation; recent facial, upper airway or upper gastrointestinal tract surgery
- oxygen saturation(SpO2) < 88% at rest with a fraction of inspired oxygen(FiO2) ≥ 0.5
- systolic blood pressure > 160mmHg or diastolic blood pressure > 100mmHg at rest
- unstable angina or a myocardial infarct in the previous four weeks
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 |
|---|---|---|
| niv plus oxygen therapyAlso: Philips Respironics BiPAP VisionNIV given on Philips Respironics BiPAP Vision apparatus. | Device | niv plus oxygen therapy |
| oxygen therapy | Device | oxygen therapy |
Primary outcome
Borg scale
Time frame: baseline,repeated measurement for about ten minutes after intervention
7 secondary outcomes
Inspiratory capacity(IC)
Time frame: baseline,repeated measurement for about ten minutes after intervention
surface electromyography(sEMG)
Time frame: baseline,repeated measurement for about ten minutes after intervention
respiratory parameters
Time frame: baseline,repeated measurement for about ten minutes after intervention
oxygen saturation(SpO2)
Time frame: baseline,repeated measurement for about ten minutes after intervention
Heart Rate(HR)
Time frame: baseline,repeated measurement for about ten minutes after intervention
the total recovery time
Time frame: repeated measurement for about ten minutes after intervention
mouth pressure(Pmo)
Time frame: baseline,repeated measurement for about ten minutes after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2014.
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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.
Rongchang Chen, M.D. principal investigator
Sate Key Laboratory of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing niv plus oxygen therapy and oxygen therapy in people with Chronic Obstructive Pulmonary Disease, 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 24 Jun 2014. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Borg scale (time frame: baseline,repeated measurement for about ten minutes after intervention). 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 24 Jun 2014.