A Multicenter, Prospective Trial of the IAB in Adults Suffering From COPD/Emphysema

Pulmonary Disease, Chronic Obstructive Clinical Trial

— IAB-1  

Official title:

A Multicenter, Prospective Trial of the IAB in Adults Suffering From COPD/Emphysema

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05087641
• Other study ID #: IAB1-CIP
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 3, 2022
• Est. completion date: January 2027

Study information

• Verified date: January 2024
• Source: Pulmair Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: January 2027
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Emphysema
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Emphysema

Intervention

Device:
• IAB System
Bronchoscopic implantation of one or multiple IABs

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre
Germany	Thoraxklinik, University of Heidelberg	Heidelberg
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Pulmair Medical, Inc.

Countries where clinical trial is conducted

Brazil,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From baseline to 90 days post implant (for endpoint evaluation)
Secondary	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.	From baseline to 90 days post implant (for endpoint evaluation)
Secondary	Efficacy - Residual Volume (RV), absolute change	Absolute change in Residual Volume (RV)	From baseline to 90 days post implant (for endpoint evaluation)
Secondary	Efficacy - Residual Volume (RV), percent change	Percent change in RV (% predicted)	From baseline to 90 days post implant (for endpoint evaluation)
Secondary	Efficacy - Forced Expiratory Volume in one second (FEV1), absolute change	Absolute change in FEV1	From baseline to 90 days post implant (for endpoint evaluation)
Secondary	Efficacy - Forced Expiratory Volume in one second (FEV1), percentage change	Percentage change in FEV1	From baseline to 90 days post implant (for endpoint evaluation)
Secondary	Efficacy - Six-Minute Walk Distance (6MWD), absolute change	Absolute change in 6MWD	From baseline to 90 days post implant (for endpoint evaluation)
Secondary	Efficacy - Six-Minute Walk Distance (6MWD), percent change	Percent change in 6MWD	From baseline to 90 days post implant (for endpoint evaluation)
Secondary	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.	From baseline to 90 days post implant (for endpoint evaluation)
Secondary	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.	From baseline to 90 days post implant (for endpoint evaluation)
Secondary	Efficacy - St. George's Respiratory Questionnaire (SGRQ), percent change	Percent change in SGRQ	From baseline to 90 days post implant (for endpoint evaluation)
Secondary	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.	From baseline to 90 days post implant (for endpoint evaluation)
Secondary	Efficacy - COPD Assessment Test (CAT) Total Score, percent change	Percent change in CAT Total Score	From baseline to 90 days post implant (for endpoint evaluation)
Secondary	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.	From baseline to 90 days post implant (for endpoint evaluation)
Secondary	Efficacy - European Quality of Life, 5-Dimensional Test (EQ-5D) Summary Index, percent change	Percent change in EQ-5D Summary Index	From baseline to 90 days post implant (for endpoint evaluation)