Clinical trial NCT00825578: Use of Endobronchial Valves in Non-Upper Lobe Heterogeneous Emphysema
Official title: Comparative Study of Bronchoscopic Lung Volume Reduction to Evaluate Relative Efficacy in Patients With Non-Upper Lobe Emphysema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heterogeneous Emphysema
Keywords: intrabronchial valve
heterogeneous emphysema
non-upper lobe
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
First posted: 2009-01-21
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: To estimate the difference between study arms in volume changes of the treated lobe(s) by CT scan
timeFrame: 6 months
Secondary outcomes:
measure: To estimate the difference between study arms in volume changes of the non-treated lobes by CT scan
timeFrame: 6 months
measure: To estimate the difference between study arms in residual volume
timeFrame: 6 months
measure: To estimate the difference between study arms in FEV1
timeFrame: 6 months
measure: To estimate the difference between study arms in gas transfer
timeFrame: 6 months
measure: To estimate the difference between study arms in modified MRC dyspnoea score
timeFrame: 6 months
measure: To estimate the difference between study arms on a 6 minute walk test
timeFrame: 6 months
measure: To estimate the difference between study arms in disease specific health status
timeFrame: 6 months
measure: To estimate the difference between study arms in dynamic hyperinflation during cycle ergometry
timeFrame: 6 months
measure: To estimate the difference between study arms in changes in respiratory and quadriceps muscle strength
timeFrame: 6 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
affiliation: Royal Brompton & Harefield NHS Foundation Trust
name: Pallav Shah, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References: