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

Hereditary Emphysema (Alpha 1-antitrypsin Deficiency) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01357460
• Other study ID #: Protocol D2.0 - 31.08.2010
• Status: Terminated
• Phase: N/A
• Start date: May 2011
• Est. completion date: December 30, 2014

Study information

• Verified date: August 2022
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: December 30, 2014
• Est. primary completion date: September 24, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alpha 1-Antitrypsin Deficiency
• Emphysema
• Hereditary Emphysema (Alpha 1-antitrypsin Deficiency)
• Pulmonary Emphysema

Intervention

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.

Locations

Country	Name	City	State
Germany	Thoraxklinik	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in pulmonary function (FEV1 (forced expiratory volume in 1 second) and RV/TLC (residual volume/total lung capacity)		3 months
Secondary	Number of major complications		3 months
Secondary	Evaluation of IBV migration rate		3 months
Secondary	Average changes in pulmonary function (FEV1, VC (vital capacity), RV, TLC, RV/TLC)		3 months
Secondary	Average changes in 6-minute-walk-distance		3 months