Neuromodulation for the treatment of moderate to severe asthma - a pilot first-in-human clinical study.

Abstract

Objective: This was a small, uncontrolled, first-in-human clinical study that evaluated the safety and efficacy of neuromodulation in patients with moderate to severe asthma.

Methods: Patients diagnosed with chronic intractable pain and moderate or severe asthma on daily asthma medications were tested and subsequently implanted with a permanent spinal cord stimulator. Patients were followed for 12 months and monitored for changes in medication use, asthma control scores, quality of life, exacerbations, ER visits and hospitalizations.

Results: 11 patients were enrolled, 9 with asthma, and 2 with asthma plus COPD. 91% of patients achieved a > 50% reduction in all asthma medication usage. For all patients enrolled there was an 88% reduction in all asthma medication use and for patients with asthma alone, there was a 98% reduction in all medication use. 100% of enrolled patients reported an Asthma Control Test (ACT) >19 with improved breathing, no wheezing, no chest tightness, and no exacerbations (average increase of 13.3 points). 100% of the enrolled patients reported an improvement in quality of life with an average increase of 3.4 points using the Asthma Quality of Life Questionnaire (AQLQ). No ER visits or hospitalizations were reported due to asthma. There were no adverse events reported.

Conclusions: Neuromodulation provided clinically meaningful improvements in asthma symptoms without the need for asthma medications and without adverse events.