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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by University of Heidelberg.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01357460
First received: May 16, 2011
Last updated: May 19, 2011
Last verified: May 2011
History of Changes
  Purpose

Patients with advanced heterogeneous emphysema due to alpha1 antitrypsin deficiency might benefit from endoscopic implantation of intrabronchial valves.


Condition Intervention Phase
Hereditary Emphysema (Alpha 1-antitrypsin Deficiency)
 Device: Implantation of intrabronchial valves (IBV) (Spiration IBV)
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic Lung Volume Reduction in Patients With Advanced Emphysema Due to alpha1 Antitrypsin Deficiency

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:
  • Improvement in pulmonary function (FEV1 (forced expiratory volume in 1 second) and RV/TLC (residual volume/total lung capacity) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of major complications [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Evaluation of IBV migration rate [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Average changes in pulmonary function (FEV1, VC (vital capacity), RV, TLC, RV/TLC) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Average changes in 6-minute-walk-distance [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: May 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Implantation of intrabronchial valves (IBV) (Spiration IBV)
    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.
    Other Name: Spiration IBV
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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01357460

Contacts
Contact: Daniela Gompelmann, MD +49(0)62213968087 daniela.gompelmann@thoraxklinik-heidelberg.de
Contact: Felix JF Herth, MD +49(0)62213961200 felix.herth@thoraxklinik-heidelberg.de

Locations
Germany
Thoraxklinik Recruiting
Heidelberg, Germany, 69126
Contact: Daniela Gompelmann, MD     +49(0)62213968087     daniela.gompelmann@thoraxklinik-heidelberg.de    
Principal Investigator: Daniela Gompelmann, MD            
Sponsors and Collaborators
University of Heidelberg
Investigators
Principal Investigator: Daniela Gompelmann, MD University of Heidelberg
  More Information

No publications provided

Responsible Party: Thoraxklinnik Heidelberg, Thoraxklinik Heidelberg
ClinicalTrials.gov Identifier: NCT01357460     History of Changes
Other Study ID Numbers: Protocol D2.0 - 31.08.2010
Study First Received: May 16, 2011
Last Updated: May 19, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Heidelberg:
Emphysema
alpha1 antitrypsin deficiency
endoscopic lung volume reduction

Additional relevant MeSH terms:
Alpha 1-Antitrypsin Deficiency
Emphysema
Pulmonary Emphysema
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Liver Diseases
Digestive System Diseases
Genetic Diseases, Inborn
 Subcutaneous Emphysema
Alpha 1-Antitrypsin
Protein C Inhibitor
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013