Clinical Trial: Endoscopic Lung Volume Reduction in Patients With Advanced Emphysema Due to alpha1 Antitrypsin Deficiency
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Endoscopic Lung Volume Reduction in Patients With Advanced Emphysema Due to alpha1 Antitrypsin Deficiency
Brief Summary: Patients with advanced heterogeneous emphysema due to alpha1 antitrypsin deficiency might benefit from endoscopic implantation of intrabronchial valves.
Detailed Summary: 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.
Sponsor: Heidelberg University
Current Primary Outcome: Improvement in pulmonary function (FEV1 (forced expiratory volume in 1 second) and RV/TLC (residual volume/total lung capacity) [ Time Frame: 3 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Heidelberg University
Dates:
Date Received: May 16, 2011
Date Started: May 2011
Date Completion: May 2012
Last Updated: May 19, 2011
Last Verified: May 2011