Endoscopic Lung Volume Reduction in Patients With Advanced Emphysema Due to alpha1 Antitrypsin Deficiency
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Heidelberg University
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Improvement in pulmonary function (FEV1 (forced expiratory volume in 1 second) and RV/TLC (residual volume/total lung capacity)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
Improvement in pulmonary function (FEV1 (forced expiratory volume in 1 second) and RV/TLC (residual volume/total lung capacity)
Time Frame: 3 months
Secondary Outcomes
- Average changes in pulmonary function (FEV1, VC (vital capacity), RV, TLC, RV/TLC)(3 months)
- Average changes in 6-minute-walk-distance(3 months)
- Evaluation of IBV migration rate(3 months)
- Number of major complications(3 months)
Investigators
Felix JF Herth
Prof. Dr. med. Felix Herth
Heidelberg University