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EmphysemaSTAGENCT02877459

Clinical Investigation of a Modified Staged Treatment Algorithm Using the AeriSeal System

A study testing AeriSeal System in people with Emphysema, run by Pulmonx Corporation at 4 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A multicenter, prospective, single-arm clinical investigation to evaluate the short term and long term safety of a modified staged treatment algorithm using the AeriSeal System. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Emphysema
What is being tested?
AeriSeal System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
4 sitesin 3 countries
Study dates
Nov 2016to 10 Aug 2018
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is willing and able to provide informed consent and to participate in the study
  • Subject is ≥ 40 years of age
  • Subject has a diagnosis of homogenous or heterogeneous upper lobe predominant emphysema confirmed by computerized tomography (CT) scan.
  • Subject has at least two (2) non-adjacent subsegments appropriate for treatment based upon CT scan in 2 different upper lobe segments in each lung (total 4 available subsegments)
  • Subject has clinically significant dyspnea scoring >1 on the mMRC scale of 0 - 4
  • Subject has a Six-Minute Walk Test (6MWT) distance ≥ 250 meters
Show all 11Show fewer
  • Subject has post-bronchodilator FEV1 ≤ 45% predicted
  • Subject has Total Lung Capacity >100% predicted
  • Subject has Residual Volume >175% predicted
  • Subject has stopped smoking for at least 8 weeks prior to entering the study as confirmed by carboxyhemoglobin or cotinine levels
  • Subject has received preventive vaccinations against potential respiratory infections consistent with local recommendations or policy

Who cannot join

  • Subject has severe bullous emphysema as judged by Investigator.
  • Subject has prior lung volume reduction surgery, prior lobectomy or pneumonectomy, prior lung transplantation, prior airway stent placement, prior pleurodesis, or prior endobronchial lung volume reduction therapy of any type
  • Subject has evidence of active respiratory infection
  • Subject has an ongoing chronic obstructive pulmonary disease (COPD) exacerbation or bronchospasm
  • Subject has a known allergy to the device components:
  • Polyether block amide - PEBAX®
Show all 54Show fewer
  • Polyvinyl Alcohol
  • Glutaraldehyde
  • Subject requires ventilatory support (invasive or non-invasive)
  • Subject has diffusing capacity of the lungs for carbon monoxide (DLco) < 20% predicted
  • Subject has a post-bronchodilator FEV1 < 20% predicted
  • Subject cannot tolerate corticosteroids or relevant antibiotics
  • Subject has relevant comorbidities as judged by the Investigator, or is deconditioned and cannot tolerate the stress of post-treatment inflammatory response
  • Subject has a history of recurrent clinically significant respiratory infections, defined as three (3) or more COPD exacerbations requiring hospitalization during the year prior to enrollment
  • Subject has severe gas exchange abnormalities as defined by any one of the following:
  • Partial pressure of arterial carbon dioxide (PaCO2) >55 mm Hg
  • Partial pressure arterial oxygen (PaO2) <45 mm Hg on room air
  • Peripheral capillary oxygen saturation (SpO2) < 90% on ≥ 4 L/min supplemental O2, at rest
  • Subject has Pulmonary hypertension, defined as peak systolic pressure > 45 mm Hg on echocardiogram or right heart catheterization
  • Subject use of systemic steroids >20 mg/day or equivalent and/or immunosuppressive agents in the 4 weeks prior to procedure
  • Subject unable to temporarily interrupt use of heparins or oral anticoagulants (e.g., warfarin, dicumarol) per Institutional recommendations. Note: antiplatelet drugs including aspirin and clopidogrel are permitted
  • Subject has alpha1 -antitrypsin serum level of <80 mg/kg (i.e. < 11 µmol/L) at Screening
  • Subject's CT scan indicates the presence of any the following radiologic abnormalities:
  • Pulmonary nodule on CT scan greater than 0.8 cm in diameter [Does not apply if present for 2 years or more without increase in size or if proven benign by biopsy/positron emission tomography (PET)]
  • Radiologic picture consistent with active pulmonary infection, e.g., unexplained parenchymal infiltrate
  • Significant interstitial lung disease
  • Significant pleural disease
  • Subject's baseline electrocardiogram (EKG) indicates arrhythmias or conduction abnormalities
  • Subject has high cardiac risk after undergoing cardiac risk assessment in accordance with published guidelines or ischemic heart disease, congestive heart failure, renal failure or cerebrovascular disease
  • Clinically significant asthma (reversible airway obstruction), chronic bronchitis, or bronchiectasis
  • Allergy or sensitivity to medications required to safely perform bronchoscopy and the AeriSeal System treatment under general anesthesia or conscious sedation
  • Participation in an investigational study of a drug, biologic, or device within 30 days prior to entering the study or planned during the course of the study.
  • Body mass index (BMI) < 15 kg/m2 or > 35 kg/m2
  • Female subject pregnant or breast-feeding
  • Abnormal screening laboratory test results as compared to reference lab normals at individual sites as follows:
  • Blood urea nitrogen > 1.5 x upper limit of normal
  • Creatinine > 1.5 x upper limit of normal
  • Aspartate aminotransferase > 1.5 x upper limit of normal
  • Alanine aminotransferase > 1.5 x upper limit of normal
  • Alkaline phosphatase > 1.5 x upper limit of normal
  • White blood cells (total) absolute < 3 x 109/L or > 1.25 x upper limit of normal
  • Hematocrit < 34 or > 1.25 x upper limit of normal
  • Platelets < 100 or > 450 K/µL
  • Prothrombin time or International Normalized Ratio (INR) > 1.5 x upper limit of normal
  • Partial thromboplastin time > 1.5x upper limit of normal
  • Positive Beta human chorionic gonadotropin (β-HCG) Pregnancy test (if female)
  • Subject has evidence of severe disease which in the judgment of the investigator may compromise survival for the duration of the study (24 months) e.g.:
  • Human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS)
  • Active malignancy
  • Stroke or Transient ischemic attack (TIA) within 12 months of Screening visit
  • Myocardial infarction within 6 months of Screening visit
  • Congestive heart failure within 6 months of Screening visit defined as clinical evidence of right or left heart failure or left ventricular ejection fraction < 45% on echocardiogram
  • Subject has been diagnosed with diabetes mellitus
  • Any condition that the Investigator believes would interfere with the intent of the study or would make participation not in the best interest of the subject i.e., alcoholism, high risk for drug abuse or noncompliance in returning for follow-up visits

Trial locations and contacts

4 sites in 3 countries.

4 sites in 3 countries

Germany2 sites

  • Charité Campus Virchow Klinikum (CVK)

    Berlin, 13353

  • Thoraxklinik am Universitäts klinikum Heidelberg

    Heidelberg, 69126

Other trials in Germany

Austria1 site

  • Ludwig-Boltzmann-Institut für COPD und Pneumologische Epidemiologie

    Vienna, 1140

Other trials in Austria

Netherlands1 site

  • University Medical Center Groningen

    Groningen, 9700 RB

Other trials in Netherlands

About this study

Official title: A Multicenter, Prospective, Single-Arm Clinical Investigation of a Modified Staged Treatment Algorithm Using the AeriSeal System - the AeriSeal-STAGE Trial

A multicenter, prospective, single-arm clinical investigation to evaluate the short term and long term safety of a modified staged treatment algorithm using the AeriSeal System.

Read the detailed description

The AeriSeal-STAGE trial will be a prospective, multicenter study that intends to evaluate the safety of a modified staged treatment algorithm with an escalation of dose using the AeriSeal System in the treatment of subjects with severe emphysema in a controlled trial design setting as compared to published data from prior studies. The trial is anticipated to enroll fifteen (15) study subjects with homogeneous, or upper lobe predominant heterogeneous emphysema, in three (3) centers in Europe.

Conditions
Emphysema
Being tested
AeriSeal System
Medical subject headings
Emphysema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AeriSeal SystemDevice

    Subjects will undergo two bronchoscopy procedures two months apart and will be treated with AeriSeal foam unilaterally, in two sub-segments during each bronchoscopy (4 segments treated in total).

Study groups in NCT02877459
Study groupRoleWhat they receive
AeriSeal SystemExperimentalSubjects will be treated with AeriSeal Foam.
Receives: Device: AeriSeal System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Serious Adverse Events

    Assessment of Serious Adverse Events (SAEs)

    To evaluate the safety of using a modified staged treatment algorithm at 3- months following the second placement of AeriSeal foam treatment in subjects with severe emphysema. The primary endpoint will be safety of AeriSeal System treatment. Safety will be assessed by monitoring the incidence of Serious Adverse Events (SAEs), during the 3-months post treatment period. Exclusively, the incidence of a prospectively specified subset of important respiratory related SAEs (COPD exacerbations requiring hospitalization or extended hospitalization, pneumonia, acute inflammatory response occurring after 30-days posttreatment, pneumothoraces), deaths and respiratory failures will be lower as compared to published data from prior studies.

    Measured: 3-months post treatment period

Secondary outcomes (7)

  1. Forced Expiratory Volume in one second (FEV1)

    Percent mean change relative to baseline at 3-months, 6-months and 12-months for FEV1

    Measured: Baseline, 3-months, 6-months and 12-months

  2. Residual volume (RV)

    Percent mean change relative to baseline at 3-months, 6-months and 12-months for RV

    Measured: Baseline, 3-months, 6-months and 12-months

  3. Exercise capacity as assessed by six-minute walk test (6MWT)

    Absolute change relative to baseline at 3-months, 6-months and 12-months for 6MWT

    Measured: Baseline, 3-months, 6-months and 12-months

  4. Quality of life as assessed by the St George's Respiratory Questionnaire (SGRQ)

    Absolute change relative to baseline at 3-months, 6-months and 12-months for SGRQ.

    The St. George's Respiratory Questionnaire measures health status (quality of life) in patients with diseases of airways obstruction. The questionnaire comprises of two parts:

    Part I: Symptoms (frequency \& severity) Part II: Activities that cause or are limited by breathlessness; Impacts (social functioning, psychological disturbances resulting from airways disease)

    A Total score is calculated which summarizes the impact of the disease on overall health status. Scores range from 0 to 100, with higher scores indicating more limitations.

    Measured: Baseline, 3-months, 6-months and 12-months

  5. Dyspnea as assessed by the Modified Medical Research Council Dyspnea Score (mMRC)

    Absolute change relative to baseline at 3-months, 6-months and 12-months for mMRC.

    The mMRC (Modified Medical Research Council) stratifies severity of dyspnea in respiratory diseases. The severity of dyspnea is rated on a scale of 0 to 4, with higher scores indicating more limitations.

    Measured: Baseline, 3-months, 6-months and 12-months

  6. Lobar volume reduction

    Lobar volume reduction of the treated lobes as quantified by computerized tomography (CT) scans at 3-months

    Measured: 3-months

  7. Radiological signs of complications on computerized tomography (CT) scans

    Radiological signs on CT scans of complications including but not limited to pneumonias, pleural effusions and consolidation at, and outside the treatment sites and formation of lung abscesses at 3-months following the second placement of AeriSeal foam.

    Measured: 3-months following the second placement of AeriSeal foam.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2016 (estimated)
  2. Study startNov 2016
  3. Primary completion16 Nov 2017
  4. Study completion10 Aug 2018

Resources

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
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02877459
Sponsor's protocol ID
630-0019
Acronym
STAGE
Status last verified
May 2019
First submitted
19 Aug 2016
Last updated
31 May 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing AeriSeal System in people with Emphysema, run by Pulmonx Corporation at 4 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 54 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: finished, as of the sponsor's last update on 31 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany, Austria, 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incidence of Serious Adverse Events (time frame: 3-months post treatment period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02877459.

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 31 May 2019.

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