EmphysemaIAB-1NCT05087641
A Multicenter, Prospective Trial of the IAB in Adults Suffering From COPD/Emphysema
A study testing IAB System in people with Emphysema and Pulmonary Disease, Chronic Obstructive, run by Pulmair Medical, Inc. at 3 sites in 3 countries.
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… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Emphysema, Pulmonary Disease, Chronic Obstructive
- What is being tested?
- IAB System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 3 May 2022to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
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.
- Conditions
- Emphysema, Pulmonary Disease, Chronic Obstructive
- Being tested
- IAB System
- Keywords
- Bronchoscopic Lung Volume Reduction (BLVR)
- Medical subject headings
- Emphysema, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IAB SystemDevice
Bronchoscopic implantation of one or multiple IABs
| Study group | Role | What they receive |
|---|---|---|
| IAB System | Experimental | Patients will be treated with IAB(s) Receives: Device: IAB System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 90 days post implant (for endpoint evaluation)
Secondary outcomes (14)
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.
Measured: From baseline to 90 days post implant (for endpoint evaluation)
Efficacy - Residual Volume (RV), absolute change
Absolute change in Residual Volume (RV)
Measured: From baseline to 90 days post implant (for endpoint evaluation)
Efficacy - Residual Volume (RV), percent change
Percent change in RV (% predicted)
Measured: From baseline to 90 days post implant (for endpoint evaluation)
Efficacy - Forced Expiratory Volume in one second (FEV1), absolute change
Absolute change in FEV1
Measured: From baseline to 90 days post implant (for endpoint evaluation)
Efficacy - Forced Expiratory Volume in one second (FEV1), percentage change
Percentage change in FEV1
Measured: From baseline to 90 days post implant (for endpoint evaluation)
Efficacy - Six-Minute Walk Distance (6MWD), absolute change
Absolute change in 6MWD
Measured: From baseline to 90 days post implant (for endpoint evaluation)
Efficacy - Six-Minute Walk Distance (6MWD), percent change
Percent change in 6MWD
Measured: From baseline to 90 days post implant (for endpoint evaluation)
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.
Measured: From baseline to 90 days post implant (for endpoint evaluation)
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.
Measured: From baseline to 90 days post implant (for endpoint evaluation)
Efficacy - St. George's Respiratory Questionnaire (SGRQ), percent change
Percent change in SGRQ
Measured: From baseline to 90 days post implant (for endpoint evaluation)
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.
Measured: From baseline to 90 days post implant (for endpoint evaluation)
Efficacy - COPD Assessment Test (CAT) Total Score, percent change
Percent change in CAT Total Score
Measured: From baseline to 90 days post implant (for endpoint evaluation)
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.
Measured: From baseline to 90 days post implant (for endpoint evaluation)
Efficacy - European Quality of Life, 5-Dimensional Test (EQ-5D) Summary Index, percent change
Percent change in EQ-5D Summary Index
Measured: From baseline to 90 days post implant (for endpoint evaluation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start3 May 2022
- Primary completion27 Mar 2024
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmphysemaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulmair Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hugo Goulart de Oliveira, MD, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087641
- Sponsor's protocol ID
- IAB1-CIP
- Acronym
- IAB-1
- Status last verified
- Mar 2026
- First submitted
- 28 Sep 2021
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective Trial of the IAB in Adults Suffering From COPD/Emphysema
- ClinicalTrials.gov ID
- NCT05087641
- Acronym / sponsor ID
- IAB-1 / IAB1-CIP
- Conditions
- Emphysema, Pulmonary Disease, Chronic Obstructive
- Keywords
- Bronchoscopic Lung Volume Reduction (BLVR)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Pulmair Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 May 2022 (actual)
- Primary completion
- 27 Mar 2024 (actual)
- Study completion
- Jan 2027 (estimated)
- First posted
- 21 Oct 2021 (actual)
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| IAB System | Experimental | Device: IAB SystemPatients will be treated with IAB(s) |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (23 listed)
- 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
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 |
|---|---|---|
| IAB SystemBronchoscopic implantation of one or multiple IABs | Device | IAB System |
Primary outcome
Safety - Incidence of respiratory serious adverse events (SAEs)
Time frame: From baseline to 90 days post implant (for endpoint evaluation)
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.
14 secondary outcomes
Safety - Incidence of other serious adverse device effects (SADEs)
Time frame: From baseline to 90 days post implant (for endpoint evaluation)
Efficacy - Residual Volume (RV), absolute change
Time frame: From baseline to 90 days post implant (for endpoint evaluation)
Efficacy - Residual Volume (RV), percent change
Time frame: From baseline to 90 days post implant (for endpoint evaluation)
Efficacy - Forced Expiratory Volume in one second (FEV1), absolute change
Time frame: From baseline to 90 days post implant (for endpoint evaluation)
Efficacy - Forced Expiratory Volume in one second (FEV1), percentage change
Time frame: From baseline to 90 days post implant (for endpoint evaluation)
Efficacy - Six-Minute Walk Distance (6MWD), absolute change
Time frame: From baseline to 90 days post implant (for endpoint evaluation)
Efficacy - Six-Minute Walk Distance (6MWD), percent change
Time frame: From baseline to 90 days post implant (for endpoint evaluation)
Efficacy - Modified Medical Research Council (mMRC) dyspnea score, absolute change
Time frame: From baseline to 90 days post implant (for endpoint evaluation)
Efficacy - St. George's Respiratory Questionnaire (SGRQ) total score, absolute change
Time frame: From baseline to 90 days post implant (for endpoint evaluation)
Efficacy - St. George's Respiratory Questionnaire (SGRQ), percent change
Time frame: From baseline to 90 days post implant (for endpoint evaluation)
Efficacy - COPD Assessment Test (CAT), absolute change
Time frame: From baseline to 90 days post implant (for endpoint evaluation)
Efficacy - COPD Assessment Test (CAT) Total Score, percent change
Time frame: From baseline to 90 days post implant (for endpoint evaluation)
Efficacy - European Quality of Life, 5-Dimensional Test (EQ-5D) Summary Index, absolute change
Time frame: From baseline to 90 days post implant (for endpoint evaluation)
Efficacy - European Quality of Life, 5-Dimensional Test (EQ-5D) Summary Index, percent change
Time frame: From baseline to 90 days post implant (for endpoint evaluation)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Hugo Goulart de Oliveira, MD, PhD principal investigator
Hospital de Clinicas de Porto Alegre
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IAB System in people with Emphysema and Pulmonary Disease, Chronic Obstructive, run by Pulmair Medical, Inc. at 3 sites in 3 countries.
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 11 inclusion and 23 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: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil, Germany, Netherlands. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Safety - Incidence of respiratory serious adverse events (SAEs) (time frame: From baseline to 90 days post implant (for endpoint evaluation)). 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 13 Mar 2026.