None listed
Conditions
Brief summary
Bronchial Thermoplasty (BT) is an approved radiofrequency treatment for patients with severe asthma. In this study we evaluate whether the treatment is likely to be useful in patients with moderately severe COPD. We explore whether BT leads to airway dilatation after treatment in the same way as it does in asthma, and whether this is accompanied by an improvement in patient symptoms.
Interventions
Patients will undergo general aneasthesia on 3 occasions over a 3 month period, and on each occasion a different portion of the lung will be treated by the bronchoscopic procedure called bronchial thermoplasty. During this procedure, a small videocamera will be passed down the wind pipe, under anaesthesia, to inspect the airways. Then, a radiofrquency catheter will be introduced through the instrument to apply 10 second bursts of low energy heat to the airways to weaken the airway muscle. It is
Patients will undergo general aneasthesia on 3 occasions over a 3 month period, and on each occasion a different portion of the lung will be treated by the bronchoscopic procedure called bronchial thermoplasty. During this procedure, a small videocamera will be passed down the wind pipe, under anaesthesia, to inspect the airways. Then, a radiofrquency catheter will be introduced through the instrument to apply 10 second bursts of low energy heat to the airways to weaken the airway muscle. It is this muscle which causes constriction and wheezing.This procedure will be performed by Prof David Langton, who is an expert in this treatment. Each procedure takes about 40 minutes in total
Sponsors
Frankston Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1 A cigarette smoking pack year history of 20 plus pack years 2 A respiratory physician diagnosis of COPD 3 A baseline FEV1 of greater than 40% predicted (so as to avoid very severe patients in case of wheezing post procedure) 4 A baseline FEV1 of less than 60% predicted (so there is no doubt about the diagnosis) 5 Using triple inhaler therapy (ie maximal bronchodilators) 6 Age >40 but <80 years 7 If female of child-bearing potential, must be using highly effective contraception 8 Resting oxygen saturation by pulse oximetry greater than 90% 9 Able and willing to provide informed consent 10 A history of exacerbations in the previous 12 months including either at least one hospital admission for COPD, or at least two oral corticosteroid requiring exacerbations.
Exclusion criteria
1 Treated with domiciliary oxygen or non-invasive ventilation 2 Poor cardiac function on echocardiogram, or pulmonary artery pressure greater than 50 mmHg 3 Active malignancy 4 Poor renal function or the need for dialysis 5 Active history of angina or myocardial infarction within last 12 months 6 Unable to achieve a 6 minute walking distance of 150metres 7 Has a Pacemaker in situ or other contraindication to radiofrequency treatment 8 BMI greater than 35 or less than 18 kg/m2 9. Two or more body CT scans in the 12 months prior to study participation
Outcome results
None listed