Denver, CONCT07709754Now EnrollingIRB Ready

Moderate to Severe Asthma Clinical Trial in Denver, CO

Access cutting-edge moderate to severe asthma treatment through this clinical trial at a research site in Denver. Study-provided care at no cost to qualified participants.

Sponsored by Spiro Medical, Inc.

Quick Self-Assessment

See if you qualify for this Denver location

Preparing your pre-screening questions…

Expert Care in Denver

Access moderate to severe asthma specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related moderate to severe asthma treatment provided free

Apply for This Denver Location

Check if you qualify for this moderate to severe asthma clinical trial in Denver, CO

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Denver

    Convenient for CO residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Denver site if eligible
  4. 4Begin participation

About This Moderate to Severe Asthma Study in Denver

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

Sponsor: Spiro Medical, Inc.

Who Can Participate

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 Exclusion Criteria:
Current smokers or subjects with a significant smoking history (e.g., \>10 pack years for subjects less than 40 years of age and \>15 pack years for subjects 40 years and older) who have smoked within the last 6 months.
Other chronic lung diseases including (but not limited to) cystic fibrosis, chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF), chronic bronchitis, vocal cord dysfunction, eosinophilic granulomatosis with polyangiitis (EGPA), history of lung cancer, or interstitial lung disease, severe scoliosis or chest wall deformities that affect lung function, or congenital disorders of the lungs or airways.
Requires continuous anticoagulant medications or taking alternative anticoagulant drugs or supplements within 10 days of implantation
History of recurrent surgical infections (e.g. MRSA)
In the 6 weeks prior to enrollment the subject has had a lower respiratory tract infection or asthma exacerbation that required: antibiotics, or systemic corticosteroids.
Patients prescribed systemic corticosteroids for any condition, other than asthma, in the last 6 weeks. Subjects with asthma on oral corticosteroids taking more than 15mg/day.
Significant coronary artery occlusive disease, angina, history of myocardial infarction and/or coronary artery stent(s), congestive heart failure, or uncontrolled cardiac arrythmias, cardiac stress test within the last 6 months with an Ejection Fraction of less than 45%
History of thoracic spine surgery and has no spinal abnormalities, i.e., no more than 5 lumbar vertebrae, no scoliosis, or spinal deformities
Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints (e.g. Crohn's disease, moderate to severe fibromyalgia, chronic pain, etc.) or a medical condition that requires the subject to be treated with systemic opioids other than for post-surgical pain
Any neurological condition that could interfere with normal lung function, including stroke, epilepsy, multiple sclerosis, Parkinson's disease, clinically significant peripheral neuropathy, or spinal cord injury (e.g., paraplegia)
Uncontrolled diabetes (A1C \> 8%, documented in the last three (3) months) or other medical condition determined by the Investigator that should be excluded
Documented history of allergic response to titanium, platinum, polyurethane, epoxy, or silicone
Planning to have diathermy, surgery requiring electrocautery, or high output ultrasonic exposure during the course of the study
Any other implanted devices (e.g., drug delivery pumps, pacemaker, ICD) including neurostimulators whether turned on or off. Passive implants (e.g., prostheses) are allowed, but no implanted metal should be at the Neurostimulator implant site, both the IPG or lead.
A female with a positive urine pregnancy test or not using adequate contraception
Currently participating in another treatment clinical trial
Subject lacks capacity to consent for themselves

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Denver?

Yes, this clinical trial (NCT07709754) has an active research site in Denver, CO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Moderate to Severe Asthma Treatment Options in Denver, CO

If you're searching for moderate to severe asthma treatment options in Denver, CO, this clinical trial (NCT07709754) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Denver research site is actively enrolling participants for this clinical trial. You'll receive care from experienced moderate to severe asthma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all moderate to severe asthma clinical trials near you to find additional studies recruiting in your area.

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