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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. The completion date has passed and the status has not been verified in more than two years.
Verified May 2011 by Heidelberg University.
Recruitment status was:  Recruiting
Information provided by:
Heidelberg University Identifier:
First received: May 16, 2011
Last updated: May 19, 2011
Last verified: May 2011
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: Intervention Model: Single Group Assignment
Masking: None (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:

Further study details as provided by Heidelberg University:

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 ]

Secondary Outcome Measures:
  • Number of major complications [ Time Frame: 3 months ]
  • Evaluation of IBV migration rate [ Time Frame: 3 months ]
  • Average changes in pulmonary function (FEV1, VC (vital capacity), RV, TLC, RV/TLC) [ Time Frame: 3 months ]
  • Average changes in 6-minute-walk-distance [ Time Frame: 3 months ]

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.

Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01357460

Contact: Daniela Gompelmann, MD +49(0)62213968087
Contact: Felix JF Herth, MD +49(0)62213961200

Thoraxklinik Recruiting
Heidelberg, Germany, 69126
Contact: Daniela Gompelmann, MD    +49(0)62213968087   
Principal Investigator: Daniela Gompelmann, MD         
Sponsors and Collaborators
Heidelberg University
Principal Investigator: Daniela Gompelmann, MD Heidelberg University
  More Information

Responsible Party: Thoraxklinnik Heidelberg, Thoraxklinik Heidelberg 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

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

Additional relevant MeSH terms:
Alpha 1-Antitrypsin Deficiency
Pulmonary Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
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 processed this record on September 21, 2017