ACTRN12621001075875Not yet recruiting未知
Pilot study of the safety and effectiveness of bronchial thermoplasty in patients with Chronic Obstructive Pulmonary Disease ages 40 to 80 years in age
Frankston Hospital0 sites10 target enrollmentStarted: August 16, 2021Last updated:
Trial Snapshot
- Phase
- 未知
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 10
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomised trial
- Primary Purpose
- Treatment
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 40 Years to 80 Years (—)
- Sex
- All
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
Investigators
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