Chronic Obstructive Pulmonary DiseaseNCT02823223
Endobronchial Valve in Patients With Heterogeneous Emphysema
A study testing Zephyr endobronchial valve placement in people with Chronic Obstructive Pulmonary Disease and Emphysema, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
To compare the clinical outcomes of Endoscopic Lung Volume Reduction using Pulmonx Zephyr Endobronchial Valve (EBV) vs. Standard of Care (SoC) in the treatment of heterogeneous emphysema patients in a controlled trial design setting. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Emphysema
- What is being tested?
- Zephyr endobronchial valve placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Jul 2018
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consent form signed
- Heterogeneous emphysema on Chest CT Scanner
- Intact interlobar fissures adjacent to the target lobe on Chest CT or collateral ventilation negative in the target lobe by Chartis assessment
- Post bronchodilator Forced expiratory volume in 1 second (FEV1) < 50% predicted
- Total Lung Capacity > 100% predicted
- Residual Volume > 150% predicted
Show all 10Show fewer
- PaO2 > 45mmHg
- Post rehabilitation 6 minute walk test > 140m
- No COPD exacerbation for at least 6 weeks
- Stopped cigarette smoking for more than 3 months
Who cannot join
- Contraindication to bronchoscopy
- Tuberculosis, pleural effusion, or clinically significant bronchiectasis
- Lung carcinoma or pulmonary nodule on CT scan requiring Chest CT scan follow-up
- Active pulmonary infection
- Prior lung transplant, LVRS, median sternotomy, bullectomy or lobectomy
- Any extrapulmonary diseases compromising survival or evaluation within the protocol (severe cardiac disease, severe renal insufficiency, cancer…)
- Inclusion in an other study assessing respiratory treatments
- Pregnant or lactating woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Prospective, Randomized, Controlled Trial of Endobronchial Valve Therapy vs. Standard of Care in Heterogeneous Emphysema
To compare the clinical outcomes of Endoscopic Lung Volume Reduction using Pulmonx Zephyr Endobronchial Valve (EBV) vs. Standard of Care (SoC) in the treatment of heterogeneous emphysema patients in a controlled trial design setting.
Read the detailed description
The aim of this prospective, randomized, controlled, one-way crossover study is to assess and compare the efficacy of the Zephyr endobronchial valves vs. Standard of Care (SoC) in patients suffering from COPD with Heterogeneous Emphysema. Patients will be followed up for 6 months after randomization. Patients in the SoC arm will crossover to the EBV treatment arm after the 6-month visit and will be followed up for 6 additional months.The primary objective is the variation of FEV1 between baseline and 3-month follow-up visit. The secondary objectives will evaluate quality of life, exercise capacity, dyspnea (including BODE index) changes, target lobe volume reduction, as well as safety outcomes.
- Conditions
- Chronic Obstructive Pulmonary Disease, Emphysema
- Being tested
- Zephyr endobronchial valve placement
- Keywords
- Endobronchial Valve
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zephyr endobronchial valve placementDevice
Patients will have ELVR (Endoscopic Lung Volume Reduction) with Zephyr valve inserted into the target lobe of the lung with the aim of complete lobar exclusion.
| Study group | Role | What they receive |
|---|---|---|
| ELVR with Endobronchial Valves | Experimental | Patients will have ELVR (Endoscopic Lung Volume Reduction) with Endobronchial Valves (Zephyr valve) inserted into the target lobe of the lung with the aim of complete lobar exclusion. Receives: Device: Zephyr endobronchial valve placement |
| Standard of Care | No intervention | Patients will receive optimal drug therapy and medical management according to clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in Forced Expiratory Volume in 1 s (FEV1)
Measured: At baseline and after 3 months
Secondary outcomes (10)
Percentage change in Forced Expiratory Volume in 1 s (FEV1)
Measured: At baseline and after 6 months
Comparison of the FEV1 using 15% Percentage change as cut-off for clinically significant change
Measured: At baseline and after 3, 6 months
Change in Residual Volume (RV)
Measured: At baseline and after 3, 6 months
Change in Total Lung Capacity (TLC)
Measured: At baseline and after 3, 6 months
Change in FEV1/FVC ratio
Measured: At baseline and after 3, 6 months
Change in St George's Respiratory Questionnaire
Measured: At baseline and after 3, 6 months
Change in 6-Min Walk Test
Measured: At baseline and after 3, 6 months
Change in BODE index
Measured: At baseline and after 3, 6 months
Change in mMRC score
Measured: At baseline and after 3, 6 months
Adverse Events and Serious Adverse Events
AEs: Type, incidence, severity, seriousness and relationship to study medications of adverse events (AE) (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE 4.0]
Measured: At each visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2017 (estimated)
- Study completionJul 2018 (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.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Liang_An, Chinese PLA General Hospital
- Investigators
- Liang_an Chen, MD, phD, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823223
- Sponsor's protocol ID
- S2016-026-01
- Status last verified
- Jun 2016
- First submitted
- 29 Jun 2016
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Because of personal privacy, the research-related individual participant data do not intend for public sharing.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Prospective, Randomized, Controlled Trial of Endobronchial Valve Therapy vs. Standard of Care in Heterogeneous Emphysema
- ClinicalTrials.gov ID
- NCT02823223
- Acronym / sponsor ID
- S2016-026-01
- Conditions
- Chronic Obstructive Pulmonary Disease, Emphysema
- Keywords
- Endobronchial Valve
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 6 Jul 2016 (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.
To compare the clinical outcomes of Endoscopic Lung Volume Reduction using Pulmonx Zephyr Endobronchial Valve (EBV) vs. Standard of Care (SoC) in the treatment of heterogeneous emphysema patients in a controlled trial design setting.
Detailed description
The aim of this prospective, randomized, controlled, one-way crossover study is to assess and compare the efficacy of the Zephyr endobronchial valves vs. Standard of Care (SoC) in patients suffering from COPD with Heterogeneous Emphysema. Patients will be followed up for 6 months after randomization. Patients in the SoC arm will crossover to the EBV treatment arm after the 6-month visit and will be followed up for 6 additional months.The primary objective is the variation of FEV1 between baseline and 3-month follow-up visit. The secondary objectives will evaluate quality of life, exercise capacity, dyspnea (including BODE index) changes, target lobe volume reduction, as well as safety outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ELVR with Endobronchial Valves | Experimental | Device: Zephyr endobronchial valve placementPatients will have ELVR (Endoscopic Lung Volume Reduction) with Endobronchial Valves (Zephyr valve) inserted into the target lobe of the lung with the aim of complete lobar exclusion. |
| Standard of Care | No intervention | –Patients will receive optimal drug therapy and medical management according to clinical practice |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Consent form signed
- Heterogeneous emphysema on Chest CT Scanner
- Intact interlobar fissures adjacent to the target lobe on Chest CT or collateral ventilation negative in the target lobe by Chartis assessment
- Post bronchodilator Forced expiratory volume in 1 second (FEV1) < 50% predicted
- Total Lung Capacity > 100% predicted
Key exclusion criteria (8 listed)
- Contraindication to bronchoscopy
- Tuberculosis, pleural effusion, or clinically significant bronchiectasis
- Lung carcinoma or pulmonary nodule on CT scan requiring Chest CT scan follow-up
- Active pulmonary infection
- Prior lung transplant, LVRS, median sternotomy, bullectomy or lobectomy
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 |
|---|---|---|
| Zephyr endobronchial valve placementPatients will have ELVR (Endoscopic Lung Volume Reduction) with Zephyr valve inserted into the target lobe of the lung with the aim of complete lobar exclusion. | Device | ELVR with Endobronchial Valves |
Primary outcome
Percentage change in Forced Expiratory Volume in 1 s (FEV1)
Time frame: At baseline and after 3 months
10 secondary outcomes
Percentage change in Forced Expiratory Volume in 1 s (FEV1)
Time frame: At baseline and after 6 months
Comparison of the FEV1 using 15% Percentage change as cut-off for clinically significant change
Time frame: At baseline and after 3, 6 months
Change in Residual Volume (RV)
Time frame: At baseline and after 3, 6 months
Change in Total Lung Capacity (TLC)
Time frame: At baseline and after 3, 6 months
Change in FEV1/FVC ratio
Time frame: At baseline and after 3, 6 months
Change in St George's Respiratory Questionnaire
Time frame: At baseline and after 3, 6 months
Change in 6-Min Walk Test
Time frame: At baseline and after 3, 6 months
Change in BODE index
Time frame: At baseline and after 3, 6 months
Change in mMRC score
Time frame: At baseline and after 3, 6 months
Adverse Events and Serious Adverse Events
Time frame: At each visits
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
- Individual participant dataSharing planned: No. Because of personal privacy, the research-related individual participant data do not intend for public sharing.
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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.
Liang_an Chen, MD, phD principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zephyr endobronchial valve placement in people with Chronic Obstructive Pulmonary Disease and Emphysema, run by Chinese PLA General Hospital 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 10 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: status not confirmed, as of the sponsor's last update on 6 Jul 2016. 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?
Results are not available in the source record.
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?
Percentage change in Forced Expiratory Volume in 1 s (FEV1) (time frame: At baseline and after 3 months). 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 6 Jul 2016.