Efficacy of bronchial thermoplasty in a patient panel with uncontrolled severe persistent asthma

Abstract

Background

Bronchial thermoplasty (BT) is an approved procedure to manage uncontrolled severe persistent asthma. Many insurance providers are reluctant to pay for BT without proven benefit among their specific patient panel.

Objective

Determine if BT is effective in a panel patient panel with uncontrolled severe persistent asthma.

Study design and methods

This was an unblinded prospective study of adult subjects with uncontrolled severe persistent asthma who underwent BT. Outcomes were assessed at baseline and then 3-, 6-, 12-, 18- and 24-months post-BT. The primary metric was an improved Asthma Quality of Life Questionnaire (AQLQ) score. Other metrics included improved Asthma Control Test (ACT), peak expiratory flow rates (PEFR), spirometry, fractional excretion of nitric oxide (FeNO), number of unscheduled medical visits, and lost days of work/activity. Respiratory adverse events were assessed during the BT treatment period and at each post-BT visit.

Results

Twenty-nine subjects completed the study; the median interquartile range (IQR) age was 47 (42-61), and the majority were female (69%), white (93%), and non-Hispanic (90%). After BT, mean (±std) AQLQ scores improved by 1.6(±1.1) at 3 months (p < 0.0001), 1.6(±1.2) at 6 months (p < 0.0001), 1.4(±1.0) at 12 months (p < 0.0001), 1.8(±1.1) at 18 months (p < 0.0001), and 1.6 (±1.5) at 24 months (p < 0.0001). There were significant improvements in ACT, PEFR, unscheduled medical visits and lost days of work and activity. Spirometry and FeNO metrics were unchanged. The average cost for subjects completing all 3 BT procedures was approximately $15,000.

Conclusion

BT is an effective adjunctive therapeutic modality in subjects with uncontrolled severe persistent asthma.

Keywords:

• Quality of life
• treatment
• efficacy
• safety
• medical costs

Acknowledgements

The authors thank Kenneth Chinsky, MD, of St. Vincent Hospital in Erie, PA for his assistance with subject recruitment and study visit activities; Sarah Carey, MS, Jade Chang, and Jacalyn Newman, PhD, of Allegheny Health Network’s Health System Publication Support Office (HSPSO) for their assistance in editing and formatting the manuscript. The HSPSO is funded by Highmark Health (Pittsburgh, PA, United States of America) and all work was done in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3).

Disclosure statement

Sandeep Bansal reports research grants from Boston Scientific, Highmark, Medtronic, GlaxoSmithKline, AstraZeneca, Shinogi, Gala Therapeutics, Bellus Health, Evidera, CSA Medical, Johnson & Johnson, Biodesix, Indivior, Verona Pharma, Pulmonx Corporation, Insmed, Lung Biotech, Delfi Diagnostics, and Roche; consultant, speaker’s bureau, and advisor for Pinnacle Biologics, Johnson & Johnson, Biodesix, GlaxoSmithKline, Veracyte, Boehringer Ingelheim, AstraZeneca, Amgen, Circulogene, Takeda, Galvanize Therapeutics, Sanofi Genzyme, Regeneron, Mylan Speciality, Theravance Biopharma US, and Delfi Diagnostics; previous speaking engagements with Medtronic, Boston Scientific, Forest Pharmaceuticals, and Gilead; and equity holder in Circulogene, Veracyte, Coolerheads, and Maxona Pharmaceuticals. The other authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.