Use of Endobronchial Valves in Non-Upper Lobe Heterogeneous Emphysema

Heterogeneous Emphysema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00825578
• Other study ID #: 08/H0708/84
• Status: Completed
• Phase: Phase 3
• First received: January 19, 2009
• Last updated: February 3, 2012
• Start date: January 2009
• Est. completion date: December 2010

Study information

• Verified date: February 2012
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emphysema
• Heterogeneous Emphysema
• Pulmonary Emphysema

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Royal Brompton Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To estimate the difference between study arms in volume changes of the treated lobe(s) by CT scan		6 months	No
Secondary	To estimate the difference between study arms in volume changes of the non-treated lobes by CT scan		6 months	No
Secondary	To estimate the difference between study arms in residual volume		6 months	No
Secondary	To estimate the difference between study arms in FEV1		6 months	No
Secondary	To estimate the difference between study arms in gas transfer		6 months	No
Secondary	To estimate the difference between study arms in modified MRC dyspnoea score		6 months	No
Secondary	To estimate the difference between study arms on a 6 minute walk test		6 months	No
Secondary	To estimate the difference between study arms in disease specific health status		6 months	No
Secondary	To estimate the difference between study arms in dynamic hyperinflation during cycle ergometry		6 months	No
Secondary	To estimate the difference between study arms in changes in respiratory and quadriceps muscle strength		6 months	No

External Links

•   Royal Brompton Hospital Respiratory Research Group website