Use of Endobronchial Valves in Non-Upper Lobe Heterogeneous Emphysema

Sponsor

Royal Brompton & Harefield NHS Foundation Trust (Other)

Overall Status

Completed

CT.gov ID

NCT00825578

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heterogeneous Emphysema	Device: Intra-bronchial valve (Spiration IBV)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparative Study of Bronchoscopic Lung Volume Reduction to Evaluate Relative Efficacy in Patients With Non-Upper Lobe Emphysema

Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Upper-lobe predominant emphysema	Device: 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. Other Names: Spiration IBV
Active Comparator: 2 Non-upper lobe predominant emphysema	Device: 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. Other Names: Spiration IBV

Arm

Intervention/Treatment

Active Comparator: 1

Upper-lobe predominant emphysema

Device: 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.

Other Names:

Spiration IBV

Active Comparator: 2

Non-upper lobe predominant emphysema

Device: Intra-bronchial valve (Spiration IBV)

Other Names:

Spiration IBV

Outcome Measures

Primary Outcome Measures

To estimate the difference between study arms in volume changes of the treated lobe(s) by CT scan [6 months]

Secondary Outcome Measures

To estimate the difference between study arms in volume changes of the non-treated lobes by CT scan [6 months]
To estimate the difference between study arms in residual volume [6 months]
To estimate the difference between study arms in FEV1 [6 months]
To estimate the difference between study arms in gas transfer [6 months]
To estimate the difference between study arms in modified MRC dyspnoea score [6 months]
To estimate the difference between study arms on a 6 minute walk test [6 months]
To estimate the difference between study arms in disease specific health status [6 months]
To estimate the difference between study arms in dynamic hyperinflation during cycle ergometry [6 months]
To estimate the difference between study arms in changes in respiratory and quadriceps muscle strength [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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