Use of Endobronchial Valves in Non-Upper Lobe Heterogeneous Emphysema

Phase 3

Completed

• Conditions: Heterogeneous Emphysema
• Interventions: Device: Intra-bronchial valve (Spiration IBV)

• Registration Number: NCT00825578
• Lead Sponsor: Royal Brompton & Harefield NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-19
• Study First Submitted QC: 2009-01-20
• Study First Posted: 2009-01-21
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-03
• Last Update Posted: 2012-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Intra-bronchial valve (Spiration IBV)	Upper-lobe predominant emphysema
2	Intra-bronchial valve (Spiration IBV)	Non-upper lobe predominant emphysema

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Royal Brompton Hospital; 🇬🇧 London, United Kingdom