Pulmonary EmphysemaPhase 2BLVRNCT02107209
Low Cost Biological Lung Volume Reduction Therapy for Advanced Emphysema
A Phase 2 study testing Bronchoscopic Lung volume reduction in people with Pulmonary Emphysema, run by Mansoura University at 1 site in Egypt.
Trial summary
The clinical utility of bronchoscopic methods for achieving lung volume reduction has been evaluated in patients with advanced emphysema because these procedures are uniformly safer than surgical volume reduction. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Pulmonary Emphysema
- What is being tested?
- Bronchoscopic Lung volume reduction
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2013to Aug 2015
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Emphysema determined by HRCT of the chest with:
- .Persistent symptoms (i.e. a baseline Modified Medical Research Council dyspnea (MRC) score of >2 despite medical therapy).
- FEV1 /FVC < 70% and FEV1 20%-50 % (Sever and very sever airflow limitation according to GOLD 2013).
- Hyperinflation (total lung capacity (TLC) > 110% pred and residual volume/total lung capacity (RV/TLC) > 120% pred.
- Patients not candidate for or had refused lung volume reduction surgery.
- Age > 40 yrs.
Who cannot join
- Airflow limitation with FEV1 < 20%.
- DLCO < 20%.
- Current smoker.
- Patients not candidate for FOB.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Chest Medicine Department, Faculty Of Medicine, Mansoura University
Al Mansurah, Al-dakahliya, 35516
About this study
Official title: Evaluation of Bronchoscopic Biological Lung Volume Reduction Therapy in Pulmonary Emphysema Patients
The clinical utility of bronchoscopic methods for achieving lung volume reduction has been evaluated in patients with advanced emphysema because these procedures are uniformly safer than surgical volume reduction. These include one-way valves, or bronchial occlusive devices to collapse emphysematous regions of lung and bronchial fenestration with bypass stents to improve expiratory flow, wire coils implants that compress the airway and thermal vapor ablation that causes an acute injury with subsequent fibrosis and reductions in volume.
Read the detailed description
Biologic lung volume reduction (BioLVR): it is a novel endobronchial approach, which uses a Biological agents aiming to reduce lung volume by blocking off the most emphysematous areas with a rapidly polymerizing sealant. The mechanism of action involves resorption atelectasis from airway occlusion, subsequent airspace inflammation, and then remodeling. This remodeling will lead to scarring that induces contraction of lung parenchyma and functional volume reduction can be expected within 6-8 weeks. Biological lung volume reduction occurs independent of the presence or absence of collateral ventilation.
- Conditions
- Pulmonary Emphysema
- Being tested
- Bronchoscopic Lung volume reduction
- Medical subject headings
- Pulmonary Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoscopic Lung volume reductionProcedure or surgery
Fiberoptic bronchoscopy is used to inject the biological agents into the targeted lung segment
| Study group | Role | What they receive |
|---|---|---|
| Bronchoscopic Lung volume reduction using Autologous blood. | Experimental | Injection of 30 ml autologous blood plus 3ml calcium chloride plus 3 ml tranexamic acid per segment via fiber-optic bronchoscope Receives: Procedure: Bronchoscopic Lung volume reduction |
| Bronchoscopic Lung volume reduction using Fibrin glue | Active comparator | injection of 30 ml locally prepared fibrin glue per segment via triple lumen balloon catheter passing through fiberoptic bronchoscopy Receives: Procedure: Bronchoscopic Lung volume reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-procedure lung volume reduction
Change from the baseline high-resolution computed tomography (HRCT) volumetry Change from the baseline Residual Volume/Total Lung Capacity from baseline.
Measured: 12 week
Secondary outcomes (1)
Post-procedure Improvement in dyspnea and exercise capacity
Changes from the baseline post-bronchodilator forced expiratory volume at one second (FEV1) and forced vital capacity (FVC), diffusing capacity of lung for carbon monoxide (DLCO), six-minute walk distance (6MWD),modified medical research council (MMRC) dyspnea score.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startApr 2013
- Primary completionApr 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmphysemaStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Bakeer, Mansoura University
- Investigators
- Ahmad Saad El-Morsi, Prof, Study chair, Chest Medicine Department, Faculty of Medicine, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02107209
- Sponsor's protocol ID
- MD68
- Acronym
- BLVR
- Status last verified
- Nov 2015
- First submitted
- 2 Apr 2014
- Last updated
- 11 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bronchoscopic Biological Lung Volume Reduction Therapy in Pulmonary Emphysema Patients
- ClinicalTrials.gov ID
- NCT02107209
- Acronym / sponsor ID
- BLVR / MD68
- Conditions
- Pulmonary Emphysema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 8 Apr 2014 (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 clinical utility of bronchoscopic methods for achieving lung volume reduction has been evaluated in patients with advanced emphysema because these procedures are uniformly safer than surgical volume reduction. These include one-way valves, or bronchial occlusive devices to collapse emphysematous regions of lung and bronchial fenestration with bypass stents to improve expiratory flow, wire coils implants that compress the airway and thermal vapor ablation that causes an acute injury with subsequent fibrosis and reductions in volume.
Detailed description
Biologic lung volume reduction (BioLVR): it is a novel endobronchial approach, which uses a Biological agents aiming to reduce lung volume by blocking off the most emphysematous areas with a rapidly polymerizing sealant. The mechanism of action involves resorption atelectasis from airway occlusion, subsequent airspace inflammation, and then remodeling. This remodeling will lead to scarring that induces contraction of lung parenchyma and functional volume reduction can be expected within 6-8 weeks. Biological lung volume reduction occurs independent of the presence or absence of collateral ventilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bronchoscopic Lung volume reduction using Autologous blood. | Experimental | Procedure: Bronchoscopic Lung volume reductionInjection of 30 ml autologous blood plus 3ml calcium chloride plus 3 ml tranexamic acid per segment via fiber-optic bronchoscope |
| Bronchoscopic Lung volume reduction using Fibrin glue | Active comparator | Procedure: Bronchoscopic Lung volume reductioninjection of 30 ml locally prepared fibrin glue per segment via triple lumen balloon catheter passing through fiberoptic bronchoscopy |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Emphysema determined by HRCT of the chest with:
- Patients not candidate for or had refused lung volume reduction surgery.
- Age > 40 yrs.
Key exclusion criteria (4 listed)
- Airflow limitation with FEV1 < 20%.
- DLCO < 20%.
- Current smoker.
- Patients not candidate for FOB.
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 |
|---|---|---|
| Bronchoscopic Lung volume reductionFiberoptic bronchoscopy is used to inject the biological agents into the targeted lung segment | Procedure or surgery | Bronchoscopic Lung volume reduction using Autologous blood., Bronchoscopic Lung volume reduction using Fibrin glue |
Primary outcome
Post-procedure lung volume reduction
Time frame: 12 week
Change from the baseline high-resolution computed tomography (HRCT) volumetry Change from the baseline Residual Volume/Total Lung Capacity from baseline.
1 secondary outcome
Post-procedure Improvement in dyspnea and exercise capacity
Time frame: 12 weeks
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 11 Nov 2015.
Related trials for Pulmonary Emphysema
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 1/2
A Study of TSRA-196 in Adults With PiZZ Alpha-1 Antitrypsin Deficiency (AATD)
Alpha-1 Antitrypsin Deficiency (AATD)
Enrolling by invitationObservational study
AATD-Liver Scan Study
Alpha-1 Antitrypsin Deficiency, AATD
RecruitingEarly Phase 1
Xenon MRI to Evaluate Changes to Lung Function Following Bronchoscopic Treatment of Air Trapping in Emphysema
Air Trapping, Emphysema
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.
Ahmad Saad El-Morsi, Prof study chair
Chest Medicine Department, Faculty of Medicine, Mansoura University
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 Bronchoscopic Lung volume reduction in people with Pulmonary Emphysema, run by Mansoura University at 1 site in Egypt.
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 6 inclusion and 4 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 11 Nov 2015. 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 Egypt. 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?
Post-procedure lung volume reduction (time frame: 12 week). 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 11 Nov 2015.