PULmonary Stimulation for Asthma Relief

Randomized, Controlled, Multi-Center, Delayed Activation Feasibility Clinical Study to Evaluate the Safety and Efficacy of Pulmonary NeuroModulation (PNM) for the Treatment of Subjects With Moderate to Severe Uncontrolled Asthma - PULSAR: Pulmonary Stimulation for Asthma Relief

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07709754

Acronym

PULSAR

Enrollment

Registered

2026-07-17

Start date

2026-08-30

Completion date

2027-06-01

Last updated

2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to Severe Asthma

Keywords

asthma, severe asthma, neuromodulation

Brief summary

This study aims to assess the safety and efficacy of Pulmonary Neuromodulation in patients suffering from moderate to severe asthma

Detailed description

The study will be a prospective, randomized, controlled, multi-Center, delayed activation feasibility study. The study is expected to complete enrollment in approximately 3 months and follow the patients per protocol for 6 months. The study will be conducted at 3-5 sites in the United States.

Interventions

DEVICESpinal Cord Stimulation

Implantation of a Spinal Cord Stimulation system

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Intervention model description

One group will be activated at implantation. The other group will undergo delayed activation of their treatment, 3 months after implantation.

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Subject has a diagnosis of uncontrolled moderate to severe asthma, diagnosed by an Allergist or Pulmonologist, for a minimum of 1 year prior to randomization. "Uncontrolled" status defined by poor symptom control, despite optimized treatment with high-dose ICS-LABA and/or biologics who have a baseline ACT score less than or equal to 15 * Subjects previously or currently on biologics for at least 6 months (Omalizumab, Mepolizumab, Reslizumab, Benralizumab, Dupilumab, Tezepelumab) that are uncontrolled and meet all inclusion and

Exclusion criteria

* 18 to 75 years of age * Subjects have a baseline AQLQ of less than 2.5 * Subject is a surgical candidate with no contraindications for PNM implantation

Design outcomes

Primary

Measure	Time frame	Description
ACT score	3 months	Proportion of subjects within both groups who achieve an Asthma Control Test (ACT) score \>19

Secondary

Measure	Time frame	Description
Asthma related Quality of Life Questionnaire (AQLQ)	3 months	Proportion of subjects within each group who achieve a clinically meaningful improvement in AQLQ

Countries

United States

Contacts

CONTACTKurt Gehlsen, MD, PhD

clinical@spiromedical.com949-421-6584

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026