Clinical trial NCT05087641: A Multicenter, Prospective Trial of the IAB in Adults Suffering From COPD/Emphysema
Official title: A Multicenter, Prospective Trial of the IAB in Adults Suffering From COPD/Emphysema
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Emphysema
Pulmonary Disease, Chronic Obstructive
Keywords: Bronchoscopic Lung Volume Reduction (BLVR)
Lead sponsor: Pulmair Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2021-10-21
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Signed Informed Consent
2. Diagnosis of COPD/emphysema
3. Age 40 to 75 years
4. Body Mass Index (BMI) less than 30 kg/m2
5. 6-minute walk Distance between 100 meters and 500 meters at baseline exam
6. Stable disease with less than 10 mg prednisone (or equivalent) daily
7. Non-smoking for 4 months prior to screening interview
8. FEV1 between 15% and 50% of predicted value at baseline exam
9. FEV1/Forced Vital Capacity (FVC) \< 70%
10. RV \> 175%
11. mMRC score ≥ 2

Exclusion Criteria:

1. Currently participating in another clinical study
2. Women of child-bearing potential
3. More than 2 COPD exacerbation episodes requiring hospitalization in the last year at screening
4. Any COPD exacerbations within 6 weeks of planned intervention
5. Two or more instances of pneumonia episodes in the last year at screening
6. Clinically significant mucus production or chronic bronchitis
7. Myocardial Infarction or unstable / uncontrolled congestive heart failure within 6 months of screening
8. Prior lung transplant, Lung Volume Reduction Surgery (LVRS), bullectomy or lobectomy
9. Clinically significant bronchiectasis
10. Unable to safely discontinue anti-coagulants or platelet activity inhibitors for 7 days
11. 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)
12. Suspected pulmonary nodule or lung cancer
13. 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:

    1. Large bullae encompassing greater than 30% of either lung
    2. Insufficient landmarks to evaluate the CT study using the software as it is intended
    3. All lobes are less than 25% parenchyma diseased (\< -950 HU)
14. Any cardiac comorbidity which the PI believes would compromise the safety of the patient after an IAB implant
15. Total Lung Capacity (TLC) \< 100% predicted at screening
16. Diffusing Capacity of Carbon Monoxide (DLCO) \< 15% or \> 50% of predicted value at screening
17. Partial pressure of carbon dioxide (PaCO2) \> 50 mm Hg or Denver scale greater than 55 mm Hg on room air at screening
18. Partial pressure of oxygen (PaO2) \< 45 mm Hg or Denver scale less than 30 mm Hg on room air at screening
19. Plasma cotinine level \> 13.7 ng/ml or carboxyhemoglobin (arterial or ear lobe capillary) \> 2.5% at screening
20. 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

Primary outcomes:
measure: Safety - Incidence of respiratory serious adverse events (SAEs)
timeFrame: From baseline to 90 days post implant (for endpoint evaluation)
Secondary outcomes:
measure: Safety - Incidence of other serious adverse device effects (SADEs)
timeFrame: From baseline to 90 days post implant (for endpoint evaluation)
measure: Efficacy - Residual Volume (RV), absolute change
timeFrame: From baseline to 90 days post implant (for endpoint evaluation)
measure: Efficacy - Residual Volume (RV), percent change
timeFrame: From baseline to 90 days post implant (for endpoint evaluation)
measure: Efficacy - Forced Expiratory Volume in one second (FEV1), absolute change
timeFrame: From baseline to 90 days post implant (for endpoint evaluation)
measure: Efficacy - Forced Expiratory Volume in one second (FEV1), percentage change
timeFrame: From baseline to 90 days post implant (for endpoint evaluation)
measure: Efficacy - Six-Minute Walk Distance (6MWD), absolute change
timeFrame: From baseline to 90 days post implant (for endpoint evaluation)
measure: Efficacy - Six-Minute Walk Distance (6MWD), percent change
timeFrame: From baseline to 90 days post implant (for endpoint evaluation)
measure: Efficacy - Modified Medical Research Council (mMRC) dyspnea score, absolute change
timeFrame: From baseline to 90 days post implant (for endpoint evaluation)
measure: Efficacy - St. George's Respiratory Questionnaire (SGRQ) total score, absolute change
timeFrame: From baseline to 90 days post implant (for endpoint evaluation)
measure: Efficacy - St. George's Respiratory Questionnaire (SGRQ), percent change
timeFrame: From baseline to 90 days post implant (for endpoint evaluation)
measure: Efficacy - COPD Assessment Test (CAT), absolute change
timeFrame: From baseline to 90 days post implant (for endpoint evaluation)
measure: Efficacy - COPD Assessment Test (CAT) Total Score, percent change
timeFrame: From baseline to 90 days post implant (for endpoint evaluation)
measure: Efficacy - European Quality of Life, 5-Dimensional Test (EQ-5D) Summary Index, absolute change
timeFrame: From baseline to 90 days post implant (for endpoint evaluation)
measure: Efficacy - European Quality of Life, 5-Dimensional Test (EQ-5D) Summary Index, percent change
timeFrame: From baseline to 90 days post implant (for endpoint evaluation)
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
city: Heidelberg
country: Germany
facility: Thoraxklinik, University of Heidelberg
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Hugo Goulart de Oliveira, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: