Use of Endobronchial Valves in Non-Upper Lobe Heterogeneous Emphysema

NCT ID: NCT00825578

Last Updated: 2012-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-12-31

Brief Summary

Hypothesis: Patients with advanced emphysema with predominance of the disease in areas other than the upper lobes, as determined by high resolution computed tomography (HRCT), could have a positive response to valve treatment.

Conditions

Heterogeneous Emphysema

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Upper-lobe predominant emphysema

Group Type: ACTIVE_COMPARATOR

Intra-bronchial valve (Spiration IBV)

Intervention Type: DEVICE

Device: Intra-bronchial valve (Spiration IBV) The IBV is comprised of a Nitnol frame and a polymer membrane, which is held against the airway mucosa by six elastic struts and will expand and contract with airway movement during breathing. The valve is designed to conform to the size and shape of the airways. The frame has 5 flexible anchors that gently secure to the mucosal wall at a controlled depth. Valves are available in 5, 6 and 7mm diameters appropriate for different airways. During a minimally invasive procedure, a catheter is passed through a bronchoscope (a flexible tube passed into the airways through the mouth) to deploy the umbrella-shaped valves into the airways. Only flexible bronchoscopy equipment is required. The valves are designed to be removed if indicated.

2

Non-upper lobe predominant emphysema

Group Type: ACTIVE_COMPARATOR

Intra-bronchial valve (Spiration IBV)

Intervention Type: DEVICE

Device: Intra-bronchial valve (Spiration IBV) The IBV is comprised of a Nitnol frame and a polymer membrane, which is held against the airway mucosa by six elastic struts and will expand and contract with airway movement during breathing. The valve is designed to conform to the size and shape of the airways. The frame has 5 flexible anchors that gently secure to the mucosal wall at a controlled depth. Valves are available in 5, 6 and 7mm diameters appropriate for different airways. During a minimally invasive procedure, a catheter is passed through a bronchoscope (a flexible tube passed into the airways through the mouth) to deploy the umbrella-shaped valves into the airways. Only flexible bronchoscopy equipment is required. The valves are designed to be removed if indicated.

Interventions

Intra-bronchial valve (Spiration IBV)

Device: Intra-bronchial valve (Spiration IBV) The IBV is comprised of a Nitnol frame and a polymer membrane, which is held against the airway mucosa by six elastic struts and will expand and contract with airway movement during breathing. The valve is designed to conform to the size and shape of the airways. The frame has 5 flexible anchors that gently secure to the mucosal wall at a controlled depth. Valves are available in 5, 6 and 7mm diameters appropriate for different airways. During a minimally invasive procedure, a catheter is passed through a bronchoscope (a flexible tube passed into the airways through the mouth) to deploy the umbrella-shaped valves into the airways. Only flexible bronchoscopy equipment is required. The valves are designed to be removed if indicated.

Intervention Type: DEVICE

Other Intervention Names

Spiration IBV

Eligibility Criteria

Inclusion Criteria

• Age 18-80 years
• Ex-smoker with smoking cessation confirmed by exhaled carbon monoxide (CO) levels
• Moderate to severe airflow obstruction FEV1 <50% Predicted
• Severe dyspnoea - mMRC ≥2
• Hyperinflation - total lung capacity (TLC) ≥100% predicted, RV ≥150% predicted
• SWT ≥75m
• Optimum COPD treatment for at least 6 weeks
• No COPD exacerbation for at least 6 weeks
• Less than 4 admissions for exacerbation in the preceding 12 months

Exclusion Criteria

• Patient unable to provide informed consent
• Patient without clear targets for airflow re-distribution
• Total lung CO uptake (TLCO) <15% predicted and FEV1 <15% predicted
• pO2 on air <6.0kPa
• pCO2 on air >8.0kPa
• Neurological, rheumatological or other cause of exercise limitation
• Other major medical illness, e.g. lung cancer that will limit participation
• Production of purulent sputum more often than not (more than 50% of days)
• Clinically significant bronchiectasis
• Large bulla - more than 1/3 of hemithorax volume (i.e. where bullectomy would be more suitable) on CT scan
• Arrhythmia or cardiovascular disease that poses a risk during procedure or exercise
• Prednisolone dose greater than 15mg a day
• Significant pulmonary hypertension - RVSP ≥45mmHg
• Left ventricular failure - left ventricular ejection fraction <45% or left ventricular fraction shortening <23%
• Prior LVRS or lobectomy
• Lung nodule requiring surgery
• Subject completed or is participating in a standard pulmonary rehabilitation program within 3 months of enrolment
• Female of childbearing age with positive pregnancy test
• Subject participated in a research study of investigational drug or device in prior 30 days
• Subject taking clopidogrel, warfarin, or other anticoagulants and unable to abstain for 5 days pre-procedure

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal Brompton & Harefield NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pallav Shah, MBBS, MD

Role: PRINCIPAL_INVESTIGATOR

Royal Brompton & Harefield NHS Foundation Trust

Locations

Royal Brompton Hospital

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

08/H0708/84

Identifier Type: -

Identifier Source: org_study_id