Chronic Obstructive Pulmonary Disease (COPD)Phase 2NCT05396131
The Use of Aeriseal ® in the Management of Collateral Ventilation Positive COPD Patients Undergoing ELVR Utilizing Endobronchial Valves.
A Phase 2 study testing Lung Sealant and Endobronchial Valve (EBV) in people with Chronic Obstructive Pulmonary Disease (COPD), run by Macquarie University, Australia at 1 site in Australia.
Trial summary
The aim of this study is to determine the feasibility of combining a lung sealant with endobronchial valves EBV in managing patients with COPD who are collateral ventilation (CV) positive. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Lung Sealant and Endobronchial Valve (EBV)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteAustralia
- Study dates
- 20 Jun 2019to 7 Jan 2022
- Phase
- Phase 2
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- i. 18-85 years of age
- ii. Forced Expiratory Volume in 1second (FEV1) 20 - 50%
- iii. Residual Volume (RV) > 175%
- iv. 6 min walk test > 150 m
- v. Completed a course of Pulmonary rehabilitation
- vi. STRATX assessment - Left Upper Lobe as the most appropriate lobe to target for ELVR
- vii. This study will be investigating heterogenous emphysema only. Minimum of 15% differential in emphysema destruction scores at -950 HU
Who cannot join
- i. Acute uncontrolled medical illness including ischemic heart disease, cardiac failure, acute renal impairment
- ii. Acute respiratory tract infections
- iii. Significant bronchiectasis,
- iv. Co-existing interstitial lung diseases, pneumothorax,
- v. Known active malignancy
- vi. Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Aeriseal ® in the Management of Collateral Ventilation Positive COPD Patients Undergoing ELVR (Endoscopic Lung Volume Reduction) Utilizing Endobronchial Valves
The aim of this study is to determine the feasibility of combining a lung sealant with endobronchial valves EBV in managing patients with COPD who are collateral ventilation (CV) positive. This study has two arms; arm 1 is for CV positive participants who will receive the lung sealant and EBV; arm 2 is the CV negative group who will only receive EBV as the standard management.
- Being tested
- Lung Sealant, Endobronchial Valve (EBV)
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung SealantDevice
Also called AeriSeal
The Aeriseal System uses a polymer foam to block or seal fissures, peripheral airways, alveoli, and collateral channels to achieve lung volume reduction.
Endobronchial Valve (EBV)Device
Also called Zephyr Endobronchial Valve System
The Zephyr EBV System are one way valves inserted into the airways to reduce lung hyperinflation.
| Study group | Role | What they receive |
|---|---|---|
| Collateral Ventilation Negative | Active comparator | Collateral Ventilation Negative participants will have endobronchial valve implant Receives: Device: Endobronchial Valve (EBV) |
| Collateral Ventilation Positive | Experimental | Collateral Ventilation Positive participants will have the lung sealant applied and the endobronchial valve implant Receives: Device: Lung Sealant; Device: Endobronchial Valve (EBV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants converted from Collateral Ventilation positive (CV+) to Collateral Ventilation negative (CV-)
Collateral ventilation status will be functionally assessed and confirmed via CHARTIS® System. Examination of left upper lobe to determine percentage of participants converted from collateral ventilation positive to a collateral ventilation negative state
Measured: 4 weeks post lung sealant application
Secondary outcomes (2)
Number of participants with improved lung functioning as measured by lung function tests
Lung function will be assessed by spirometry, plethysmography, lung diffusion capacity and capillary blood test
Measured: 12weeks and 52 weeks post valve implant
Changes Lung volume
Changes in lung volume will be assessed using high resolution computed tomography (HRCT) and target lobe volume reduction (TLVR)
Measured: 12weeks and 52 weeks post valve implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start20 Jun 2019
- Primary completion7 Jan 2022
- Study completion7 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants diagnosed as either Collateral Ventilation (CV) Negative or CV Positive. CV Negative participants will only receive the endobronchial valves (EBV). CV Positive participants will receive both the lung sealant and the EBV.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Macquarie University, Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alvin J Ing, MBBS, MD, FRACP, Principal investigator, Clinical Professor and Respiratory Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396131
- Sponsor's protocol ID
- AI-MCVP-COPD-ELVR
- Status last verified
- May 2022
- First submitted
- 20 Sep 2021
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ing AJ, Jayapadman A, Kim WV, Ly C, Ho-Shon K, Lilburn P, Carew A, Ng BJH, Saghaie T, Williamson JP. Reversal of collateral ventilation using endoscopic polymer foam in COPD patients undergoing endoscopic lung volume reduction with endobronchial valves: A controlled parallel group trial. Respirology. 2022 Dec;27(12):1064-1072. doi: 10.1111/resp.14338. Epub 2022 Aug 2.
PubMed 35918295
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Aeriseal ® in the Management of Collateral Ventilation Positive COPD Patients Undergoing ELVR (Endoscopic Lung Volume Reduction) Utilizing Endobronchial Valves
- ClinicalTrials.gov ID
- NCT05396131
- Acronym / sponsor ID
- AI-MCVP-COPD-ELVR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Macquarie University, AustraliaUniversity, hospital or other
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 7 Jan 2022 (actual)
- Study completion
- 7 Jan 2022 (actual)
- First posted
- 31 May 2022 (actual)
- 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 the feasibility of combining a lung sealant with endobronchial valves EBV in managing patients with COPD who are collateral ventilation (CV) positive. This study has two arms; arm 1 is for CV positive participants who will receive the lung sealant and EBV; arm 2 is the CV negative group who will only receive EBV as the standard management.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants diagnosed as either Collateral Ventilation (CV) Negative or CV Positive. CV Negative participants will only receive the endobronchial valves (EBV). CV Positive participants will receive both the lung sealant and the EBV.
| Arm | Type | Receives |
|---|---|---|
| Collateral Ventilation Negative | Active comparator | Device: Endobronchial Valve (EBV)Collateral Ventilation Negative participants will have endobronchial valve implant |
| Collateral Ventilation Positive | Experimental | Device: Lung Sealant, Device: Endobronchial Valve (EBV)Collateral Ventilation Positive participants will have the lung sealant applied and the endobronchial valve implant |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- i. 18-85 years of age
- ii. Forced Expiratory Volume in 1second (FEV1) 20 - 50%
- iii. Residual Volume (RV) > 175%
- iv. 6 min walk test > 150 m
- v. Completed a course of Pulmonary rehabilitation
Key exclusion criteria (6 listed)
- i. Acute uncontrolled medical illness including ischemic heart disease, cardiac failure, acute renal impairment
- ii. Acute respiratory tract infections
- iii. Significant bronchiectasis,
- iv. Co-existing interstitial lung diseases, pneumothorax,
- v. Known active malignancy
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 |
|---|---|---|
| Lung SealantAlso: AeriSealThe Aeriseal System uses a polymer foam to block or seal fissures, peripheral airways, alveoli, and collateral channels to achieve lung volume reduction. | Device | Collateral Ventilation Positive |
| Endobronchial Valve (EBV)Also: Zephyr Endobronchial Valve SystemThe Zephyr EBV System are one way valves inserted into the airways to reduce lung hyperinflation. | Device | Collateral Ventilation Negative, Collateral Ventilation Positive |
Primary outcome
Number of Participants converted from Collateral Ventilation positive (CV+) to Collateral Ventilation negative (CV-)
Time frame: 4 weeks post lung sealant application
Collateral ventilation status will be functionally assessed and confirmed via CHARTIS® System. Examination of left upper lobe to determine percentage of participants converted from collateral ventilation positive to a collateral ventilation negative state
2 secondary outcomes
Number of participants with improved lung functioning as measured by lung function tests
Time frame: 12weeks and 52 weeks post valve implant
Changes Lung volume
Time frame: 12weeks and 52 weeks post valve implant
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 31 May 2022.
- Derived from this study: PubMed 35918295Ing AJ, Jayapadman A, Kim WV, Ly C, Ho-Shon K, Lilburn P, Carew A, Ng BJH, Saghaie T, Williamson JP. Reversal of collateral ventilation using endoscopic polymer foam in COPD patients undergoing endoscopic lung volume reduction with endobronchial valves: A controlled parallel group trial. Respirology. 2022 Dec;27(12):1064-1072. doi: 10.1111/resp.14338. Epub 2022 Aug 2.
- Individual participant dataSharing planned: No
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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.
Alvin J Ing, MBBS, MD, FRACP principal investigator
Clinical Professor and Respiratory Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lung Sealant and Endobronchial Valve (EBV) in people with Chronic Obstructive Pulmonary Disease (COPD), run by Macquarie University, Australia at 1 site in Australia.
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 7 inclusion and 6 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 31 May 2022. 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 Australia. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of Participants converted from Collateral Ventilation positive (CV+) to Collateral Ventilation negative (CV-) (time frame: 4 weeks post lung sealant application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05396131, which also lists 1 linked publication.
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 31 May 2022.