Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05854550


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT05854550
Ethics application status
Date submitted
20/04/2023
Date registered
11/05/2023
Date last updated
4/10/2023

Titles & IDs
Public title
First in Human Study to Assess an Implant to Treat Severe Emphysema
Scientific title
Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung
Secondary ID [1] 0 0
CIP-0001
Universal Trial Number (UTN)
Trial acronym
BREATHE-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emphysema or COPD 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Apreo Implant Group

Experimental: Apreo Implant Group - This group will undergo up to 2 procedures and will receive up to 3 implants during in each lung.


Treatment: Devices: Apreo Implant Group
One or two procedures involving placement of up to three Apreo implants in the bronchial tree of each lung.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of Serious Adverse Events (SAE) at 6 Months
Timepoint [1] 0 0
6 Months
Secondary outcome [1] 0 0
Device Evaluation: Device Deployment Assessment
Timepoint [1] 0 0
During Procedure
Secondary outcome [2] 0 0
Device Evaluation: Device Usability Survey
Timepoint [2] 0 0
During Procedure
Secondary outcome [3] 0 0
Device Evaluation: Instructions for Use (IFU) Survey
Timepoint [3] 0 0
During Procedure
Secondary outcome [4] 0 0
Efficacy Evaluation: Airway Patency at 30 Days
Timepoint [4] 0 0
30 Days
Secondary outcome [5] 0 0
Efficacy Evaluation: Airway Patency at 3 Months
Timepoint [5] 0 0
3 Months
Secondary outcome [6] 0 0
Efficacy Evaluation: Airway Patency at 6 Months
Timepoint [6] 0 0
6 Months
Secondary outcome [7] 0 0
Efficacy Evaluation: Airway Patency at 12 Months
Timepoint [7] 0 0
12 Months
Secondary outcome [8] 0 0
Efficacy Evaluation: Mucus Assessment at 30 Days
Timepoint [8] 0 0
30 Days
Secondary outcome [9] 0 0
Efficacy Evaluation: Mucus Assessment at 3 Months
Timepoint [9] 0 0
3 Months
Secondary outcome [10] 0 0
Efficacy Evaluation: Mucus Assessment at 6 Months
Timepoint [10] 0 0
6 Months
Secondary outcome [11] 0 0
Efficacy Evaluation: Mucus Assessment at 12 Months
Timepoint [11] 0 0
12 Months
Secondary outcome [12] 0 0
Efficacy Evaluation: Computed Tomography (CT) Scan at 6 Months
Timepoint [12] 0 0
6 Months
Secondary outcome [13] 0 0
Efficacy Evaluation: CT Scan at 12 Months
Timepoint [13] 0 0
12 Months
Secondary outcome [14] 0 0
Efficacy Evaluation: Forced Expiratory Volume in 1 Second (FEV1) at 1-3 Days
Timepoint [14] 0 0
1-3 Days
Secondary outcome [15] 0 0
Efficacy Evaluation: FEV1 at 30 Days
Timepoint [15] 0 0
30 Days
Secondary outcome [16] 0 0
Efficacy Evaluation: FEV1 at 3 Months
Timepoint [16] 0 0
3 Months
Secondary outcome [17] 0 0
Efficacy Evaluation: FEV1 at 6 Months
Timepoint [17] 0 0
6 Months
Secondary outcome [18] 0 0
Efficacy Evaluation: FEV1 at 12 Months
Timepoint [18] 0 0
12 Months
Secondary outcome [19] 0 0
Efficacy Evaluation: Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) at 6 Months
Timepoint [19] 0 0
6 Months
Secondary outcome [20] 0 0
Efficacy Evaluation: Residual Volume (RV) at 6 Months
Timepoint [20] 0 0
6 Months
Secondary outcome [21] 0 0
Efficacy Evaluation: Residual Volume (RV) at 12 Months
Timepoint [21] 0 0
12 Months
Secondary outcome [22] 0 0
Efficacy Evaluation: Arterial Blood Gas (ABG): PaO2 at 6 Months
Timepoint [22] 0 0
6 Months
Secondary outcome [23] 0 0
Efficacy Evaluation: Arterial Blood Gas (ABG): PaCO2 at 6 Months
Timepoint [23] 0 0
6 Months
Secondary outcome [24] 0 0
Safety: Procedural Complications
Timepoint [24] 0 0
Through 24 hours post-procedure
Secondary outcome [25] 0 0
Safety: Rate of SAEs
Timepoint [25] 0 0
Through 12 Months
Secondary outcome [26] 0 0
Safety: Rate of Adverse Device Effects
Timepoint [26] 0 0
Through 12 Months
Secondary outcome [27] 0 0
Efficacy Evaluation: Forced Expiratory Volume at 1 Second/ Forced Vital Capacity (FEV1/FVC) at 1-3 Days
Timepoint [27] 0 0
1-3 Days
Secondary outcome [28] 0 0
Efficacy Evaluation: FEV1/FVC at 30 Days
Timepoint [28] 0 0
30 Days
Secondary outcome [29] 0 0
Efficacy Evaluation: FEV1/FVC at 3 Months
Timepoint [29] 0 0
3 Months
Secondary outcome [30] 0 0
Efficacy Evaluation: FEV1/FVC at 6 Months
Timepoint [30] 0 0
6 Months
Secondary outcome [31] 0 0
Efficacy Evaluation: FEV1/FVC at 12 Months
Timepoint [31] 0 0
12 Months
Secondary outcome [32] 0 0
Efficacy Evaluation: RV Assessed by Pulmonary Function Testing at 1-3 Days
Timepoint [32] 0 0
1-3 Days
Secondary outcome [33] 0 0
Efficacy Evaluation: RV Assessed by Pulmonary Function Testing at 30 Days
Timepoint [33] 0 0
30 Days
Secondary outcome [34] 0 0
Efficacy Evaluation: RV Assessed by Pulmonary Function Testing at 3 Months
Timepoint [34] 0 0
3 Months
Secondary outcome [35] 0 0
Efficacy Evaluation: RV Assessed by Pulmonary Function Testing at 6 Months
Timepoint [35] 0 0
6 Months
Secondary outcome [36] 0 0
Efficacy Evaluation: RV Assessed by Pulmonary Function Testing at 12 Months
Timepoint [36] 0 0
12 Months
Secondary outcome [37] 0 0
Efficacy Evaluation: Residual Volume/Total Lung Capacity (RV/TLC) at 1-3 Days
Timepoint [37] 0 0
1-3 Days
Secondary outcome [38] 0 0
Efficacy Evaluation: RV/TLC at 30 Days
Timepoint [38] 0 0
30 Days
Secondary outcome [39] 0 0
Efficacy Evaluation: RV/TLC at 3 Months
Timepoint [39] 0 0
3 Months
Secondary outcome [40] 0 0
Efficacy Evaluation: RV/TLC at 6 Months
Timepoint [40] 0 0
6 Months
Secondary outcome [41] 0 0
Efficacy Evaluation: RV/TLC at 12 Months
Timepoint [41] 0 0
12 Months
Secondary outcome [42] 0 0
Efficacy Evaluation: Forced Vital Capacity (FVC) at 1-3 Days
Timepoint [42] 0 0
1-3 Days
Secondary outcome [43] 0 0
Efficacy Evaluation: FVC at 30 Days
Timepoint [43] 0 0
30 Days
Secondary outcome [44] 0 0
Efficacy Evaluation: FVC at 3 Months
Timepoint [44] 0 0
3 Months
Secondary outcome [45] 0 0
Efficacy Evaluation: FVC at 6 Months
Timepoint [45] 0 0
6 Months
Secondary outcome [46] 0 0
Efficacy Evaluation: FVC at 12 Months
Timepoint [46] 0 0
12 Months
Secondary outcome [47] 0 0
Efficacy Evaluation: Six Minute Walk Test (6MWT) at 1-3 Days
Timepoint [47] 0 0
1-3 Days
Secondary outcome [48] 0 0
Efficacy Evaluation: Six Minute Walk Test (6MWT) at 30 Days
Timepoint [48] 0 0
30 Days
Secondary outcome [49] 0 0
Efficacy Evaluation: Six Minute Walk Test (6MWT) at 3 Months
Timepoint [49] 0 0
3 Months
Secondary outcome [50] 0 0
Efficacy Evaluation: Six Minute Walk Test (6MWT) at 6 Months
Timepoint [50] 0 0
6 Months
Secondary outcome [51] 0 0
Efficacy Evaluation: Six Minute Walk Test (6MWT) at 12 Months
Timepoint [51] 0 0
12 Months
Secondary outcome [52] 0 0
Efficacy Evaluation: Modified Borg Dyspnoea Scale at 1-3 Days
Timepoint [52] 0 0
1-3 Days
Secondary outcome [53] 0 0
Efficacy Evaluation: Modified Borg Dyspnoea Scale at 30 Days
Timepoint [53] 0 0
30 Days
Secondary outcome [54] 0 0
Efficacy Evaluation: Modified Borg Dyspnoea Scale at 3 Months
Timepoint [54] 0 0
3 Months
Secondary outcome [55] 0 0
Efficacy Evaluation: Modified Borg Dyspnoea Scale at 6 Months
Timepoint [55] 0 0
6 Months
Secondary outcome [56] 0 0
Efficacy Evaluation: Modified Borg Dyspnoea Scale at 12 Months
Timepoint [56] 0 0
12 Months
Secondary outcome [57] 0 0
Efficacy Evaluation: COPD Assessment Test (CAT) at 1-3 Days (CAT scores range from 0 to 40, with higher score denoting higher impact of COPD on a participant's life)
Timepoint [57] 0 0
1-3 Days
Secondary outcome [58] 0 0
Efficacy Evaluation: COPD Assessment Test (CAT) at 30 Days (CAT scores range from 0 to 40, with higher score denoting higher impact of COPD on a participant's life)
Timepoint [58] 0 0
30 Days
Secondary outcome [59] 0 0
Efficacy Evaluation: Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) at 3 Months (CAT scores range from 0 to 40, with higher score denoting higher impact of COPD on a participant's life)
Timepoint [59] 0 0
3 Months
Secondary outcome [60] 0 0
Efficacy Evaluation: COPD Assessment Test (CAT) at 6 Months (CAT scores range from 0 to 40, with higher score denoting higher impact of COPD on a participant's life)
Timepoint [60] 0 0
6 Months
Secondary outcome [61] 0 0
Efficacy Evaluation: COPD Assessment Test (CAT) at 12 Months (CAT scores range from 0 to 40, with higher score denoting higher impact of COPD on a participant's life)
Timepoint [61] 0 0
12 Months
Secondary outcome [62] 0 0
Efficacy Evaluation: St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at 1-3 Days (scores range from 0 to 100, with higher scores indicating more limitations to daily living)
Timepoint [62] 0 0
1-3 Days
Secondary outcome [63] 0 0
Efficacy Evaluation: St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at 30 Days (scores range from 0 to 100, with higher scores indicating more limitations to daily living)
Timepoint [63] 0 0
30 Days
Secondary outcome [64] 0 0
Efficacy Evaluation: St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at 3 Months (scores range from 0 to 100, with higher scores indicating more limitations to daily living)
Timepoint [64] 0 0
3 Months
Secondary outcome [65] 0 0
Efficacy Evaluation: St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at 6 Months (scores range from 0 to 100, with higher scores indicating more limitations to daily living)
Timepoint [65] 0 0
6 Months
Secondary outcome [66] 0 0
Efficacy Evaluation: St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at 12 Months (scores range from 0 to 100, with higher scores indicating more limitations to daily living)
Timepoint [66] 0 0
12 Months
Secondary outcome [67] 0 0
Efficacy Evaluation: Modified Medical Research Council (mMRC) Dyspnea Scale (0=no breathlessness except with strenuous exercise to 4=too breathless to leave the house or breathless when dressing or undressing) at 1-3 Days
Timepoint [67] 0 0
1-3 Days
Secondary outcome [68] 0 0
Efficacy Evaluation: Modified Medical Research Council (mMRC) Dyspnea Scale (0=no breathlessness except with strenuous exercise to 4=too breathless to leave the house or breathless when dressing or undressing) at 30 Days
Timepoint [68] 0 0
30 Days
Secondary outcome [69] 0 0
Efficacy Evaluation: Modified Medical Research Council (mMRC) Dyspnea Scale (0=no breathlessness except with strenuous exercise to 4=too breathless to leave the house or breathless when dressing or undressing) at 3 Months
Timepoint [69] 0 0
3 Months
Secondary outcome [70] 0 0
Efficacy Evaluation: Modified Medical Research Council (mMRC) Dyspnea Scale (0=no breathlessness except with strenuous exercise to 4=too breathless to leave the house or breathless when dressing or undressing) at 6 Months
Timepoint [70] 0 0
6 Months
Secondary outcome [71] 0 0
Efficacy Evaluation: Modified Medical Research Council (mMRC) Dyspnea Scale (0=no breathlessness except with strenuous exercise to 4=too breathless to leave the house or breathless when dressing or undressing) at 12 Months
Timepoint [71] 0 0
12 Months

Eligibility
Key inclusion criteria
1. Age = 35 and = 80 years old

2. Computed tomography (CT) scan evidence of homogeneous or heterogeneous emphysema

3. At least one target lobe with > 35% destruction (percent of voxels with < -950
Hounsfield units on CT)

4. Post-bronchodilator ratio of FEV1/FVC < 0.7 at screening

5. Post-bronchodilator FEV1 percent predicted =20% and =50% of predicted at screening

6. Post-bronchodilator RV > 180% predicted

7. Post-bronchodilator RV/TLC = 0.55 at screening

8. Marked dyspnea, scoring = 2 on the modified Medical Research Council scale of 0-4

9. Cotinine testing at screening indicates nonsmoker and stopped smoking at least 8 weeks
before entering the trial and agrees to refrain from smoking for duration of study
participation

10. Participation in a pulmonary rehabilitation program and/or confirmed to have been
engaged or attempted regular physical activity in the 12 months prior to the first
Apreo Procedure and agrees to continue or restart regular physical activity for the
duration of the study

11. Fully vaccinated for Covid-19 (up to date per Australian Government Guidelines) and
has current pneumococcus and influenza vaccination (or documented clinical
intolerance)

12. Cognitively and physically able to provide written informed consent and complete
participant questionnaires
Minimum age
35 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Arterial blood PaCO2 > 60 mmHg (8 kPa) or PaO2 = 45 mmHg (6 kPa)

2. DLCO <20% at screening

3. Steroid therapy of 10 mg prednisolone (prednisone) or more per day

4. Three or more acute exacerbations of COPD in the past year before enrollment

5. Two or more hospitalizations for acute exacerbations of COPD or respiratory infections
in the past year before enrollment

6. Any acute exacerbation of COPD or respiratory infection less than 4 weeks before the
first Apreo Procedure

7. Previous lung volume reduction surgery or lobectomy, segmentectomy or bullectomy,
vapor, glue, or other pulmonary device implant

8. Known history of pulmonary arterial hypertension

9. Presence of a giant bulla (= 30% of hemithorax)

10. History of excessive dynamic airway collapse of the trachea or main bronchi

11. History of adult asthma or chronic bronchitis

12. Presence of suspicious pulmonary nodule/infiltrate that requires additional follow-up,
diagnostics or treatment

13. Unequivocal and symptomatic bronchiectasis

14. Unequivocal lung cancer or other current cancer diagnosis except non-metastasized
basal cell skin cancer

15. Uncontrolled hypertension (blood pressure that is inadequately treated or resistant to
treatment) with a systolic > 200 mmHg or diastolic > 110 mmHg at screening or prior to
first Apreo Procedure

16. Uncorrectable coagulopathy or other condition likely to increase risk of peri- or
post- Apreo Procedure bleeding

17. On anticoagulant or antiplatelet therapy and unable or unwilling to hold for Apreo
Procedure

18. Coronary artery disease with angina

19. History of myocardial infarction within 6 months

20. History of a stroke less than 1 year before the first Apreo Procedure

21. Clinical history of heart failure with documented LVEF = 40%

22. Clinical history of diabetes with a HbA1c > 9.0%

23. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 (CKD-EPI) OR participant
with kidney failure (Stage 5 kidney disease)

24. Mechanical ventilator dependence except participants using nocturnal bi-level positive
airway pressure (biPAP) or continuous positive airway pressure (CPAP) are allowed if
it would not preclude safe implantation of the study device

25. Pregnant, lactating, or women of childbearing potential who plan to become pregnant
within the study duration

26. Known hypersensitivity to nitinol

27. Significantly immunocompromised, such as organ transplant recipients, those with
congenital immune deficiencies, AIDS, or severe rheumatoid arthritis

28. Any disease or condition likely to limit survival to less than one year

29. Concomitant illnesses or medications that may pose a significant increased risk for
complications following an Apreo Procedure

30. Currently enrolled in another trial and actively receiving experimental treatment

31. Any condition in the opinion of the investigator that would interfere with safe and
complete collection of study data including the safe conduction of bronchoscopy
procedures

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Macquarie University Hospital - Macquarie
Recruitment hospital [2] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2109 - Macquarie
Recruitment postcode(s) [2] 0 0
3050 - Parkville

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Apreo Health, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The goal of this clinical trial is to test the feasibility of an implant for severe emphysema
in up to 30 participants. The main questions it aims to answer are:

Is it safe? Does it work?

Participants who meet eligibility criteria will have up to two procedures 30 days apart, in
which up to 3 implants will be placed in each lung during the procedure(s). Participants will
be asked to return for follow-up visits at 30 days, and 3, 6, and 12 months after the
procedure(s).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05854550
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Shirin Hasan
Address 0 0
Country 0 0
Phone 0 0
+1 408-250-5881
Fax 0 0
Email 0 0
shasan@thefoundry.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05854550

Additional trial details provided through ANZCTR
Accrual to date
3
Recruiting in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 141
Royal Melbourne Hospital - City campus
Recruitment hospital [2] 142
Macquarie University
Recruitment postcode(s) [1] 142
2109
Recruitment postcode(s) [2] 143
3050
Funding & Sponsors
Funding source category [1] 85
Commercial sector/Industry
Name [1] 85
Apreo Health Australia Pty Ltd
Address [1] 85
c/o Prime Accounting # Business Advisory ‘HWT Tower’ Level 17, 40 City Road, Southbank, VIC 3006
Country [1] 85
Australia
Primary sponsor
Commercial sector/Industry
Primary sponsor name
Apreo Health Australia Pty Ltd
Primary sponsor address
c/o Prime Accounting # Business Advisory ‘HWT Tower’ Level 17, 40 City Road, Southbank, VIC 3006
Primary sponsor country
Australia
Ethics approval
Ethics application status
Approved
Ethics committee name [1] 62
Macquarie University HREC
Address [1] 62
Balaclava Road, North Ryde New South Wales 2109
Country [1] 62
Australia
Date submitted for ethics approval [1] 62
13/02/2023
Approval date [1] 62
23/02/2023
Ethics approval number [1] 62
Reference No:520231304946439
Ethics committee name [2] 63
Royal Melbourne Hospital HREC
Address [2] 63
300 Grattan Street Parkville, VIC 3050
Country [2] 63
Australia
Date submitted for ethics approval [2] 63
29/11/2022
Approval date [2] 63
23/03/2023
Ethics approval number [2] 63
HREC Reference Number: HREC/91821/MH-2022
 
Public notes

Contacts
Principal investigator
Title 389 0
A/Prof
Name 389 0
Daniel Steinfort
Address 389 0
Royal Melbourne Hospital - City Campus 300 Grattan Street Parkville, VIC 3050
Country 389 0
Australia
Phone 389 0
+61416275750
Fax 389 0
Email 389 0
Daniel.Steinfort@mh.org.au
Contact person for public queries
Title 390 0
Mr
Name 390 0
Matt Godden
Address 390 0
Level 1 / 424 Burke Road Camberwell, VIC 3124
Country 390 0
Australia
Phone 390 0
+61400007127
Fax 390 0
Email 390 0
matt@australianhealthcaresolutions.com.au
Contact person for scientific queries
Title 391 0
A/Prof
Name 391 0
Daniel Steinfort
Address 391 0
Royal Melbourne Hospital - City Campus 300 Grattan Street Parkville, VIC 3050
Country 391 0
Australia
Phone 391 0
+61416275750
Fax 391 0
Email 391 0
Daniel.Steinfort@mh.org.au