search
Back to results

Endoscopic Lung Volume Reduction in Patients With Advanced Emphysema Due to alpha1 Antitrypsin Deficiency

Primary Purpose

Hereditary Emphysema (Alpha 1-antitrypsin Deficiency)

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Implantation of intrabronchial valves (IBV) (Spiration IBV)
Sponsored by
Heidelberg University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hereditary Emphysema (Alpha 1-antitrypsin Deficiency) focused on measuring Emphysema, alpha1 antitrypsin deficiency, endoscopic lung volume reduction

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • pulmonary function: FEV1 < 45 %, RV > 150 %, TLC > 100 %
  • alpha1 antitrypsin deficiency (< 80 mg/dl), genotype: PiZS, PiZZ, Pi0/0
  • heterogenous emphysema

Exclusion Criteria:

  • homogenous emphysema
  • significant bronchiectasis
  • severe concomitant diseases
  • pregnancy

Sites / Locations

  • Thoraxklinik

Outcomes

Primary Outcome Measures

Improvement in pulmonary function (FEV1 (forced expiratory volume in 1 second) and RV/TLC (residual volume/total lung capacity)

Secondary Outcome Measures

Number of major complications
Evaluation of IBV migration rate
Average changes in pulmonary function (FEV1, VC (vital capacity), RV, TLC, RV/TLC)
Average changes in 6-minute-walk-distance

Full Information

First Posted
May 16, 2011
Last Updated
August 24, 2022
Sponsor
Heidelberg University
search

1. Study Identification

Unique Protocol Identification Number
NCT01357460
Brief Title
Endoscopic Lung Volume Reduction in Patients With Advanced Emphysema Due to alpha1 Antitrypsin Deficiency
Official Title
Endoscopic Lung Volume Reduction in Patients With Advanced Emphysema Due to alpha1 Antitrypsin Deficiency
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
difficult patient recruitment
Study Start Date
May 2011 (Actual)
Primary Completion Date
September 24, 2014 (Actual)
Study Completion Date
December 30, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University

4. Oversight

5. Study Description

Brief Summary
Patients with advanced heterogeneous emphysema due to alpha1 antitrypsin deficiency might benefit from endoscopic implantation of intrabronchial valves.
Detailed Description
Patient enrollment and data acquisition is to be carried out on a prospective basis. It is planned to enroll a total of 25 patients with advanced heterogeneous emphysema due to alpha1 antitrypsin deficiency. All patients will undergo treatment at one study centre in Heidelberg. Therapy of all patients consists of implantation of intrabronchial valves (IBV, Spiration, Olympus) in the most emphysematous destroyed lobe.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hereditary Emphysema (Alpha 1-antitrypsin Deficiency)
Keywords
Emphysema, alpha1 antitrypsin deficiency, endoscopic lung volume reduction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Implantation of intrabronchial valves (IBV) (Spiration IBV)
Other Intervention Name(s)
Spiration IBV
Intervention Description
In advanced emphysema due to alpha1 antitrypsin deficiency even optimum treatment including drugs, physical training and possibly oxygen therapy is unable to influence exercise dyspnoea and exercise capacity.Implantation of intrabronchial valves in the most destroyed and hyperinflated lung lobe can improve the elastic recoil of the small airways by a reduction in lung volume and thus leading to more ergonomic breathing mechanics and diaphragm function.The one-way mechanism of these valves allows air to escape from the downstream lung segment without any influx of "new" air during inspiration.
Primary Outcome Measure Information:
Title
Improvement in pulmonary function (FEV1 (forced expiratory volume in 1 second) and RV/TLC (residual volume/total lung capacity)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of major complications
Time Frame
3 months
Title
Evaluation of IBV migration rate
Time Frame
3 months
Title
Average changes in pulmonary function (FEV1, VC (vital capacity), RV, TLC, RV/TLC)
Time Frame
3 months
Title
Average changes in 6-minute-walk-distance
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: pulmonary function: FEV1 < 45 %, RV > 150 %, TLC > 100 % alpha1 antitrypsin deficiency (< 80 mg/dl), genotype: PiZS, PiZZ, Pi0/0 heterogenous emphysema Exclusion Criteria: homogenous emphysema significant bronchiectasis severe concomitant diseases pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela Gompelmann, MD
Organizational Affiliation
Heidelberg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thoraxklinik
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Endoscopic Lung Volume Reduction in Patients With Advanced Emphysema Due to alpha1 Antitrypsin Deficiency

We'll reach out to this number within 24 hrs