European Multi-center Post Market Study of the IBV Valve System

Olympus

Status

Completed

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Device: IBV Valve

Study type

Interventional

Funder types

Industry

Identifiers

NCT00880724

CPR-01576 AD

Details and patient eligibility

About

The objective of this randomized, blinded, multicenter, controlled study is to compare the performance of the IBV Valve System (treatment group) to a control group receiving a sham bronchoscopy procedure without valve placement.

Full description

The IBV Valve System (Spiration Inc. Redmond, WA) has CE Mark approval for the treatment of diseased and damaged lung. The devices are one-way valves that can be placed in the airways via flexible bronchoscopy limiting airflow distally. For the treatment of emphysema, valves are placed in airways communicating to the most diseased areas of lung tissue to re-direct airflow to less diseased areas. A multicenter, blinded and randomized study of these valves is being conducted in 7 centers in 6 European countries. The study is evaluating the effectiveness of this therapy for the treatment of upper lobe predominant emphysema in patients with severe to very severe emphysema (GOLD classification 3 to 4) that despite best medical management continue having poor quality of life, severe symptoms and physical limitations. The primary endpoints are to measure and compare responses using the St. George's Respiratory Questionnaire and lung volume changes as measured by CT-scans. Consented patients that meet the strict inclusion criteria have a bronchoscopic procedure and are randomized into treatment or control (no valves) groups. After the procedure, all patients stay blinded to their group assignment and have follow-up evaluations at 1 and 3 months. After the 3-month evaluation, each patient is un-blinded. The treatment group is then scheduled for an additional follow-up at 6 months and the control group is offered valve treatment (rollover) and evaluated approximately 3 months later.

Enrollment

100 estimated patients

Sex

All

Ages

40 to 74 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Between 40 and 74 years of age
Predominantly upper lobe emphysema and severe dyspnea
Satisfies the criteria of the ATS/ERS Guidelines for Management of Stable COPD
Physical ability to participate in the study by performing a 6-minute walk distance of > 140m
No cigarette smoking for 4 months and willing to abstain throughout the study
Severe airflow obstruction defined by FEV1 45% of predicted
Severe hyperinflation defined by: TLC > 100% of predicted and RV > 150% of predicted

Exclusion criteria

Between 70 and 74 years of age and an FEV1 or DLCO < 20% of predicted
Severe gas exchange abnormalities
Major medical disease that will limit evaluation, participation or follow-up
Active asthma component to their disease
Giant bulla (> 1/3 volume of lung)
Severe pulmonary hypertension
Requirement for > 6L02 to keep saturation > 90% with exercise
Evidence of systemic disease or neoplasia expected to compromise survival during the 6-month study period