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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01357460
First Posted: May 20, 2011
Last Update Posted: May 20, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Heidelberg University
May 16, 2011
May 20, 2011
May 20, 2011
May 2011
May 2012   (Final data collection date for primary outcome measure)
Improvement in pulmonary function (FEV1 (forced expiratory volume in 1 second) and RV/TLC (residual volume/total lung capacity) [ Time Frame: 3 months ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Endoscopic Lung Volume Reduction in Patients With Advanced Emphysema Due to alpha1 Antitrypsin Deficiency
Endoscopic Lung Volume Reduction in Patients With Advanced Emphysema Due to alpha1 Antitrypsin Deficiency
Patients with advanced heterogeneous emphysema due to alpha1 antitrypsin deficiency might benefit from endoscopic implantation of intrabronchial valves.
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.
Interventional
Phase 2
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hereditary Emphysema (Alpha 1-antitrypsin Deficiency)
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
25
May 2012
May 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
30 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01357460
Protocol D2.0 - 31.08.2010
Not Provided
Not Provided
Not Provided
Thoraxklinnik Heidelberg, Thoraxklinik Heidelberg
Heidelberg University
Not Provided
Principal Investigator: Daniela Gompelmann, MD Heidelberg University
Heidelberg University
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP