Endoscopic Lung Volume Reduction in Patients With Advanced Emphysema Due to alpha1 Antitrypsin Deficiency

Heidelberg University

Status: Terminated

Conditions: Hereditary Emphysema (Alpha 1-antitrypsin Deficiency)

Treatments: Device: Implantation of intrabronchial valves (IBV) (Spiration IBV)

Study type: Interventional

Funder types: Other

Identifiers

NCT01357460

Protocol D2.0 - 31.08.2010

Details and patient eligibility

About

Patients with advanced heterogeneous emphysema due to alpha1 antitrypsin deficiency might benefit from endoscopic implantation of intrabronchial valves.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)