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

NCT02877459 | Completed DMC

• 1 other identifier: 630-0019
• Study Type: interventional
• Target: 14
• Locations: 3 countries
• Sites: 4

Brief 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.

Conditions

Emphysema

Outcome Measures

Primary Outcomes (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.

  3-months post treatment period

Secondary Outcomes (7)

• Forced Expiratory Volume in one second (FEV1)

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

• Residual volume (RV)

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

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

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

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

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

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

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

Study Arms (1)

AeriSeal System

EXPERIMENTAL

Subjects will be treated with AeriSeal Foam.

Device: AeriSeal System

Interventions

AeriSeal System DEVICE

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).

AeriSeal System

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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®
• 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:

Sponsors & Collaborators

• Pulmonx Corporation: lead

Study Sites (4)

Ludwig-Boltzmann-Institut für COPD und Pneumologische Epidemiologie

Vienna, 1140, Austria

Location

Charité Campus Virchow Klinikum (CVK)

Berlin, 13353, Germany

Location

Thoraxklinik am Universitäts klinikum Heidelberg

Heidelberg, 69126, Germany

Location

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

MeSH Terms

Conditions

Emphysema

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Narinder Shargill, PhD

  Pulmonx Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2016
• First Posted: August 24, 2016
• Study Start: November 1, 2016
• Primary Completion: November 16, 2017
• Study Completion: August 10, 2018
• Last Updated: May 31, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); AU (1); DE (2)