Back to resultsA Multicenter, Prospective Trial of the IAB in Adults Suffering From COPD/Emphysema (IAB-1)
Primary Purpose
Emphysema, Pulmonary Disease, Chronic Obstructive
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
IAB System
Sponsored by
About this trial
This is an interventional treatment trial for Emphysema focused on measuring Bronchoscopic Lung Volume Reduction (BLVR)
Eligibility Criteria
Inclusion Criteria:
- Signed Informed Consent
- Diagnosis of COPD/emphysema
- Age 40 to 75 years
- Body Mass Index (BMI) less than 30 kg/m2
- 6-minute walk Distance between 100 meters and 500 meters at baseline exam
- Stable disease with less than 10 mg prednisone (or equivalent) daily
- Non-smoking for 4 months prior to screening interview
- FEV1 between 15% and 50% of predicted value at baseline exam
- FEV1/Forced Vital Capacity (FVC) < 70%
- RV > 175%
- mMRC score ≥ 2
Exclusion Criteria:
- Currently participating in another clinical study
- Women of child-bearing potential
- More than 2 COPD exacerbation episodes requiring hospitalization in the last year at screening
- Any COPD exacerbations within 6 weeks of planned intervention
- Two or more instances of pneumonia episodes in the last year at screening
- Clinically significant mucus production or chronic bronchitis
- Myocardial Infarction or unstable / uncontrolled congestive heart failure within 6 months of screening
- Prior lung transplant, Lung Volume Reduction Surgery (LVRS), bullectomy or lobectomy
- Clinically significant bronchiectasis
- Unable to safely discontinue anti-coagulants or platelet activity inhibitors for 7 days
- Uncontrolled pulmonary hypertension (systolic pulmonary arterial pressure > 45 mm Hg) or evidence or history of cor pulmonale as determined by recent echocardiogram (completed within the last 3 months prior to screening visit)
- Suspected pulmonary nodule or lung cancer
High Resolution Computed Tomography (HRCT) collected per CT scanning protocol within the last 6 months of screening date and evaluated by clinical site personnel using 3D segmentation software shows:
- Large bullae encompassing greater than 30% of either lung
- Insufficient landmarks to evaluate the CT study using the software as it is intended
- All lobes are less than 25% parenchyma diseased (< -950 HU)
- Any cardiac comorbidity which the PI believes would compromise the safety of the patient after an IAB implant
- Total Lung Capacity (TLC) < 100% predicted at screening
- Diffusing Capacity of Carbon Monoxide (DLCO) < 15% or > 50% of predicted value at screening
- Partial pressure of carbon dioxide (PaCO2) > 50 mm Hg or Denver scale greater than 55 mm Hg on room air at screening
- Partial pressure of oxygen (PaO2) < 45 mm Hg or Denver scale less than 30 mm Hg on room air at screening
- Plasma cotinine level > 13.7 ng/ml or carboxyhemoglobin (arterial or ear lobe capillary) > 2.5% at screening
- Any other conditions, which, in the opinion of the Investigator, would make the patient unsuitable for inclusion, or could interfere with the patient participating in or completing the study
Sites / Locations
- Hospital de Clinicas de Porto AlegreRecruiting
- Thoraxklinik, University of HeidelbergRecruiting
- University Medical Center GroningenRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IAB System
Arm Description
Patients will be treated with IAB(s)
Outcomes
Primary Outcome Measures
Safety - Incidence of respiratory serious adverse events (SAEs)
The primary endpoint is the occurrence of respiratory SAEs:
Acute asthma/bronchospasm requiring intensive/critical care unit admission
Acute COPD exacerbation (is acute onset, life-threatening, requires hospitalization)
Airway injury from IAB placement/migration/airway stenosis requiring surgical intervention
Death from procedure/IAB
Massive hemoptysis (est. >100 ml in 24hr requiring transfusion, surgery, or arterial embolization) from procedure/IAB
Pneumonia in treated lobe requiring hospitaliz., IV antibiotics, IAB removal
Pneumonia NOT in treated lobe (is life-threatening, acute onset, requires hospitaliz. & IV antibiotics)
Pneumothorax requiring surgery
Tension pneumothorax (is life-threatening, acute onset, requires hospitaliz. & treatment)
Respiratory failure requiring mechanical ventilatory support >24hr
A thoracic SAE composite, based on number of subjects experiencing a thoracic SAE, will also be calculated and tabulated.
Secondary Outcome Measures
Safety - Incidence of other serious adverse device effects (SADEs)
All other SADEs are a secondary endpoint, made from the accumulation of adverse events (AEs) to be recorded as they occur regardless of the follow-up schedule.
Efficacy - Residual Volume (RV), absolute change
Absolute change in Residual Volume (RV)
Efficacy - Residual Volume (RV), percent change
Percent change in RV (% predicted)
Efficacy - Forced Expiratory Volume in one second (FEV1), absolute change
Absolute change in FEV1
Efficacy - Forced Expiratory Volume in one second (FEV1), percentage change
Percentage change in FEV1
Efficacy - Six-Minute Walk Distance (6MWD), absolute change
Absolute change in 6MWD
Efficacy - Six-Minute Walk Distance (6MWD), percent change
Percent change in 6MWD
Efficacy - Modified Medical Research Council (mMRC) dyspnea score, absolute change
Absolute change in mMRC dyspnea score. Scores range from 0-4, with a decrease in score representing improved perception of disability attributable to dyspnea.
Efficacy - St. George's Respiratory Questionnaire (SGRQ) total score, absolute change
Absolute change in SGRQ total score. Scores range from 0-100, with a decrease in score representing overall improvement in health, daily life, and perceived well-being.
Efficacy - St. George's Respiratory Questionnaire (SGRQ), percent change
Percent change in SGRQ
Efficacy - COPD Assessment Test (CAT), absolute change
Absolute changes in CAT. Scores range from 0-40, with a decrease in score representing decreased impact of cough, sputum, dyspnea, and chest tightness on overall health status.
Efficacy - COPD Assessment Test (CAT) Total Score, percent change
Percent change in CAT Total Score
Efficacy - European Quality of Life, 5-Dimensional Test (EQ-5D) Summary Index, absolute change
Absolute change in EQ-5D Summary Index. Index values range from 0-1, with a decrease in index value indicating an improvement in health-related quality of life.
Efficacy - European Quality of Life, 5-Dimensional Test (EQ-5D) Summary Index, percent change
Percent change in EQ-5D Summary Index
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05087641
Brief Title
A Multicenter, Prospective Trial of the IAB in Adults Suffering From COPD/Emphysema
Acronym
IAB-1
Official Title
A Multicenter, Prospective Trial of the IAB in Adults Suffering From COPD/Emphysema
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pulmair Medical, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The Pulmair Implantable Artificial Bronchus (IAB) is a device intended for implantation into the diseased bronchi of emphysema patients. The IAB is indicated for bronchoscopic treatment of adults with Chronic Obstructive Pulmonary Disease (COPD)/emphysema to relieve hyperinflation and allow bidirectional ventilation of the affected lobes.
The objective of this trial is to demonstrate a suitable benefit/risk profile to support a subsequent trial of the safety and effectiveness of the IAB to achieve its intended purpose.
The trial will enroll 24 subjects implanted with IAB(s), at no more than three study centers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emphysema, Pulmonary Disease, Chronic Obstructive
Keywords
Bronchoscopic Lung Volume Reduction (BLVR)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is an open-label (unblinded), multicenter, prospective trial of the Implantable Artificial Bronchus (IAB) in adults suffering from COPD/emphysema. There is no control group or comparator.
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IAB System
Arm Type
Experimental
Arm Description
Patients will be treated with IAB(s)
Intervention Type
Device
Intervention Name(s)
IAB System
Intervention Description
Bronchoscopic implantation of one or multiple IABs
Primary Outcome Measure Information:
Title
Safety - Incidence of respiratory serious adverse events (SAEs)
Description
The primary endpoint is the occurrence of respiratory SAEs:
Acute asthma/bronchospasm requiring intensive/critical care unit admission
Acute COPD exacerbation (is acute onset, life-threatening, requires hospitalization)
Airway injury from IAB placement/migration/airway stenosis requiring surgical intervention
Death from procedure/IAB
Massive hemoptysis (est. >100 ml in 24hr requiring transfusion, surgery, or arterial embolization) from procedure/IAB
Pneumonia in treated lobe requiring hospitaliz., IV antibiotics, IAB removal
Pneumonia NOT in treated lobe (is life-threatening, acute onset, requires hospitaliz. & IV antibiotics)
Pneumothorax requiring surgery
Tension pneumothorax (is life-threatening, acute onset, requires hospitaliz. & treatment)
Respiratory failure requiring mechanical ventilatory support >24hr
A thoracic SAE composite, based on number of subjects experiencing a thoracic SAE, will also be calculated and tabulated.
Time Frame
From baseline to 90 days post implant (for endpoint evaluation)
Secondary Outcome Measure Information:
Title
Safety - Incidence of other serious adverse device effects (SADEs)
Description
All other SADEs are a secondary endpoint, made from the accumulation of adverse events (AEs) to be recorded as they occur regardless of the follow-up schedule.
Time Frame
From baseline to 90 days post implant (for endpoint evaluation)
Title
Efficacy - Residual Volume (RV), absolute change
Description
Absolute change in Residual Volume (RV)
Time Frame
From baseline to 90 days post implant (for endpoint evaluation)
Title
Efficacy - Residual Volume (RV), percent change
Description
Percent change in RV (% predicted)
Time Frame
From baseline to 90 days post implant (for endpoint evaluation)
Title
Efficacy - Forced Expiratory Volume in one second (FEV1), absolute change
Description
Absolute change in FEV1
Time Frame
From baseline to 90 days post implant (for endpoint evaluation)
Title
Efficacy - Forced Expiratory Volume in one second (FEV1), percentage change
Description
Percentage change in FEV1
Time Frame
From baseline to 90 days post implant (for endpoint evaluation)
Title
Efficacy - Six-Minute Walk Distance (6MWD), absolute change
Description
Absolute change in 6MWD
Time Frame
From baseline to 90 days post implant (for endpoint evaluation)
Title
Efficacy - Six-Minute Walk Distance (6MWD), percent change
Description
Percent change in 6MWD
Time Frame
From baseline to 90 days post implant (for endpoint evaluation)
Title
Efficacy - Modified Medical Research Council (mMRC) dyspnea score, absolute change
Description
Absolute change in mMRC dyspnea score. Scores range from 0-4, with a decrease in score representing improved perception of disability attributable to dyspnea.
Time Frame
From baseline to 90 days post implant (for endpoint evaluation)
Title
Efficacy - St. George's Respiratory Questionnaire (SGRQ) total score, absolute change
Description
Absolute change in SGRQ total score. Scores range from 0-100, with a decrease in score representing overall improvement in health, daily life, and perceived well-being.
Time Frame
From baseline to 90 days post implant (for endpoint evaluation)
Title
Efficacy - St. George's Respiratory Questionnaire (SGRQ), percent change
Description
Percent change in SGRQ
Time Frame
From baseline to 90 days post implant (for endpoint evaluation)
Title
Efficacy - COPD Assessment Test (CAT), absolute change
Description
Absolute changes in CAT. Scores range from 0-40, with a decrease in score representing decreased impact of cough, sputum, dyspnea, and chest tightness on overall health status.
Time Frame
From baseline to 90 days post implant (for endpoint evaluation)
Title
Efficacy - COPD Assessment Test (CAT) Total Score, percent change
Description
Percent change in CAT Total Score
Time Frame
From baseline to 90 days post implant (for endpoint evaluation)
Title
Efficacy - European Quality of Life, 5-Dimensional Test (EQ-5D) Summary Index, absolute change
Description
Absolute change in EQ-5D Summary Index. Index values range from 0-1, with a decrease in index value indicating an improvement in health-related quality of life.
Time Frame
From baseline to 90 days post implant (for endpoint evaluation)
Title
Efficacy - European Quality of Life, 5-Dimensional Test (EQ-5D) Summary Index, percent change
Description
Percent change in EQ-5D Summary Index
Time Frame
From baseline to 90 days post implant (for endpoint evaluation)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed Informed Consent
Diagnosis of COPD/emphysema
Age 40 to 75 years
Body Mass Index (BMI) less than 30 kg/m2
6-minute walk Distance between 100 meters and 500 meters at baseline exam
Stable disease with less than 10 mg prednisone (or equivalent) daily
Non-smoking for 4 months prior to screening interview
FEV1 between 15% and 50% of predicted value at baseline exam
FEV1/Forced Vital Capacity (FVC) < 70%
RV > 175%
mMRC score ≥ 2
Exclusion Criteria:
Currently participating in another clinical study
Women of child-bearing potential
More than 2 COPD exacerbation episodes requiring hospitalization in the last year at screening
Any COPD exacerbations within 6 weeks of planned intervention
Two or more instances of pneumonia episodes in the last year at screening
Clinically significant mucus production or chronic bronchitis
Myocardial Infarction or unstable / uncontrolled congestive heart failure within 6 months of screening
Prior lung transplant, Lung Volume Reduction Surgery (LVRS), bullectomy or lobectomy
Clinically significant bronchiectasis
Unable to safely discontinue anti-coagulants or platelet activity inhibitors for 7 days
Uncontrolled pulmonary hypertension (systolic pulmonary arterial pressure > 45 mm Hg) or evidence or history of cor pulmonale as determined by recent echocardiogram (completed within the last 3 months prior to screening visit)
Suspected pulmonary nodule or lung cancer
High Resolution Computed Tomography (HRCT) collected per CT scanning protocol within the last 6 months of screening date and evaluated by clinical site personnel using 3D segmentation software shows:
Large bullae encompassing greater than 30% of either lung
Insufficient landmarks to evaluate the CT study using the software as it is intended
All lobes are less than 25% parenchyma diseased (< -950 HU)
Any cardiac comorbidity which the PI believes would compromise the safety of the patient after an IAB implant
Total Lung Capacity (TLC) < 100% predicted at screening
Diffusing Capacity of Carbon Monoxide (DLCO) < 15% or > 50% of predicted value at screening
Partial pressure of carbon dioxide (PaCO2) > 50 mm Hg or Denver scale greater than 55 mm Hg on room air at screening
Partial pressure of oxygen (PaO2) < 45 mm Hg or Denver scale less than 30 mm Hg on room air at screening
Plasma cotinine level > 13.7 ng/ml or carboxyhemoglobin (arterial or ear lobe capillary) > 2.5% at screening
Any other conditions, which, in the opinion of the Investigator, would make the patient unsuitable for inclusion, or could interfere with the patient participating in or completing the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gina Daniel
Phone
+1 (858) 369-0000
Email
gdaniel@pulmair.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugo Goulart de Oliveira, MD, PhD
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
CEP 90035-003
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hugo Goulart de Oliveira, MD, PhD
Facility Name
Thoraxklinik, University of Heidelberg
City
Heidelberg
ZIP/Postal Code
D-69126
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felix JF Herth, MD, PhD
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dirk-Jan Slebos, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Multicenter, Prospective Trial of the IAB in Adults Suffering From COPD/Emphysema
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