Implant to help adults with severe emphysema
A Multicenter, Prospective Trial Evaluating the Safety and Efficacy of the Implantable Artificial Bronchus (IAB) in Adults Suffering From Severe Emphysema
This study will test whether an implantable artificial bronchus can improve breathing and safety in adults with severe COPD/emphysema.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Pulmair Medical, Inc. Industry-sponsored |
| Drugs / interventions | prednisone |
| Locations | 4 sites (San Francisco, California and 3 other locations) |
| Trial ID | NCT07119229 on ClinicalTrials.gov |
What this trial studies
IAB-2 is an open-label, multicenter, prospective trial that implants an artificial bronchus device in adults with severe COPD/emphysema and follows them for safety and functional outcomes. There is no control or sham group; all enrolled participants receive the device. The trial is planned at multiple sites across the United States and at centers in the Netherlands, Germany, and Brazil. Key eligibility includes severe airflow obstruction, significant emphysema on CT, reduced exercise capacity, and a period of smoking abstinence prior to enrollment.
Who should consider this trial
Good fit: Adults age 22 and older with diagnosed severe COPD/emphysema who are non-smokers for at least four months, have FEV1 15–50% predicted, FEV1/FVC <70%, RV >175% predicted, a 6-minute walk distance of 100–400 meters, BMI 18–32, mMRC ≥2, and qualifying emphysema on CT are the intended candidates.
Not a fit: People with mild disease, active smokers, those who do not meet the CT emphysema or physiologic criteria, or those with major comorbidities or contraindications to the implant are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the implant could improve airflow, reduce lung hyperinflation, and increase exercise capacity and quality of life for people with severe emphysema.
How similar studies have performed: Other bronchoscopic lung-volume-reduction devices such as endobronchial valves and coils have shown benefit in selected patients, but the implantable artificial bronchus is a newer approach with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Signed Informed Consent.
2. Diagnosis of COPD/emphysema.
3. At least 22-years of age.
4. 18 ≤ BMI ≤ 32.
5. 6-minute walk Distance between 100-meters and 400-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 (including tobacco, vaping, marijuana, etc.).
8. FEV1 between 15% and 50% of predicted value at baseline exam.
9. FEV1/FVC \<70%.
10. Subject has ≥25% emphysema destruction score in each lung defined by areas of low attenuation \<-950 HU, as determined by CT core lab.
11. Subject has homogeneous or heterogeneous emphysema, and at least one lung has a 15% difference between upper and lower lobes in emphysema destruction score (\< -950HU) as determined by CT core lab.
12. RV \> 175% of predicted value.
13. mMRC score ≥ 2.
Exclusion Criteria:
* 1\. Currently participating in another clinical study that involves surgery, interventional or pharmaceutical treatment..
2\. α-1 Antitrypsin deficiency 3. Women of child-bearing potential. 4. More than 2 COPD exacerbation episodes requiring hospitalization in the last year prior to screening.
5\. Any COPD exacerbations requiring hospitalization within 6-weeks of planned intervention.
6\. Two or more instances of pneumonia episodes requiring hospitalization in the last year prior to screening.
7\. Clinically significant mucus production or chronic bronchitis. 8. Myocardial Infarction or unstable / uncontrolled congestive heart failure within 6-months of screening.
9\. Prior lung transplant, LVRS, bullectomy, lobectomy or endoscopic lung volume reduction (ELVR).
10\. Clinically significant bronchiectasis. 11. Unable to safely discontinue anti-coagulants or platelet activity inhibitors for 7-days.
12\. 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). Note: the echocardiogram is not a required screening procedure.
13\. Suspected malignant pulmonary nodule or other lung cancer. 14. 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) 15. Any cardiac comorbidity which the PI believes would compromise the safety of the patient after an IAB implant.
16\. TLC \< 100% predicted at screening. 17. DLCO \< 15% or \> 50% of predicted value at screening. 18. PaCO2 \> 50 mm Hg at screening. 19. PaO2 \< 45 mm Hg in room air at screening. 20. Plasma cotinine level \> 13.7 ng/ml or carboxyhemoglobin (arterial or ear lobe capillary) \>2.5% at screening.
21\. Current diagnosis of substance abuse disorder. 22. Current diagnosis of any of the following: Major Depressive Disorder (MDD), Schizoaffective Disorder, Schizophrenia, Borderline Personality Disorder, Bipolar Disorder.
23\. 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.
Where this trial is running
San Francisco, California and 3 other locations
- University of California, San Francisco — San Francisco, California, United States (Not_yet_recruiting)
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
- Northwestern University — Chicago, Illinois, United States (Recruiting)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Adnan Majid, MD — Beth Israel Deaconess Medical Center
- Study coordinator: VP Clincal Operations
- Email: tkruger@pulmair.com
- Phone: 858-369-0000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.