Endoscopic Lung Volume Reduction in Patients With Advanced Emphysema Due to alpha1 Antitrypsin Deficiency
Not Applicable
Terminated
- Conditions
- Hereditary Emphysema (Alpha 1-antitrypsin Deficiency)
- Registration Number
- NCT01357460
- Lead Sponsor
- Heidelberg University
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 18
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Improvement in pulmonary function (FEV1 (forced expiratory volume in 1 second) and RV/TLC (residual volume/total lung capacity) 3 months
- Secondary Outcome Measures
Name Time Method Number of major complications 3 months Evaluation of IBV migration rate 3 months Average changes in pulmonary function (FEV1, VC (vital capacity), RV, TLC, RV/TLC) 3 months Average changes in 6-minute-walk-distance 3 months
Trial Locations
- Locations (1)
Thoraxklinik
🇩🇪Heidelberg, Germany