Good asthmatic control with bronchial thermoplasty, upto 5 years, finds study
A recent clinical trial named as The PAS2 study has indicated that improvements in asthma control with respect to severe exacerbations, hospitalizations and ER visits after bronchial thermoplasty are durable out to 5 years, and reductions in ICS and maintenance OCS usage are maintained.
The findings were presented at the 2020 CHEST Annual Meeting, held virtually October 18 to 21and have recently been published in Allergy And Airway.
Bronchial thermoplasty (BT) is a non-pharmacologic, device-based treatment for subjects ≥18 years with severe persistent asthma not well controlled with inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA). The "Post-FDA Approval Clinical Trial Evaluating BT in Severe Persistent Asthma (PAS2)" study collects follow-up data for subjects undergoing BT treatment with the AlairTM BT System. The research team has reported results for major endpoints to 5 years of follow-up.
The PAS2 study is a prospective, open-label, observational, multi-center trial at US and Canadian centers. Subjects 18-65 years taking ICS ≥1000μg/day (beclomethasone or equivalent) and LABA ≥80μg/day (salmeterol or equivalent) were enrolled. Additional inclusion criteria were: pre-bronchodilator FEV1 ≥60% predicted, non-smoker for ≥1 year (<10 pack/years if former smoker), ≥2 days with asthma symptoms in the last 4 weeks, AQLQ ≤6.25, and in the 12 months prior to BT treatment have ≤2 hospitalizations, ≤3 lower respiratory tract infections, and ≤3 severe exacerbations. Subjects diagnosed with other severe respiratory diseases were excluded. Baseline demographics were recorded.
On data analysis the following facts emerged.
- 284 subjects were enrolled at 27 centers; 279 subjects had at least 1 of 3 BT procedures; 271 subjects had all 3 BT procedures. At baseline subjects (64.5% female) had mean age 45.7 years, mean BMI 32.2kg/m2, and mean AQLQ of 4.03. 227 returned for their 5-year follow-up.
- Reductions in healthcare utilization observed post-BT persisted to the 5-year follow-up.
- The percentages of subjects with severe exacerbations at 12 months prior to BT and 1-5 years post-BT were 78%, 50%, 47%, 47%, 44%, and 43%, respectively.
- Similar patterns were seen for hospitalizations and ER visits for asthma. Mean ICS dose dropped from 2272μg/day at baseline to 1910-2080μg/day for years 1-5.
- The percentage of patients using maintenance OCS was 19.4% at baseline but was reduced to 8.1%-10.7% during years 1-5.
- Omalizumab usage dropped from 16% at baseline to 11% at year 5; however, use of mepolizumab and benralizumab increased over the study period to 6.6% and 0.9%, respectively, at 5 years. FEV1 and FVC remained stable after BT treatment.
- Data also confirmed the safety of the BT procedure to 5 years.
For ful atricle follow the link:https://doi.org/10.1016/j.chest.2020.08.059
