Maskless Medicinal Delivery System for Aerosolized Medication (JettPak™) for Children with Asthma:  A Phase I-II Study

Investigator:  Adam Williams, MD

Status: Recruiting

Phase: 1-2

Sponsor: JettStream

Contact: Mollie Ball, 541-706-6594 or

Location: Bend, Oregon (Central Oregon)

Purpose: As the first study of the JettPak™ device in humans, and in children who because of their age could most benefit from the device, a phase I  to randomized phase II trial design will be utilized. Both budesonide and albuterol will be delivered via the JettPak™, the former in all patients and the latter as needed and prescribed.

Inclusion Criteria:

  • The patient must be 18 months to 10 years (prior to their 11th birthday) of age.
  • The patient has been prescribed treatment with inhaled corticosteroid therapy .
  • The parent/legal guardian consents to be in the study and must have signed the study’s informed consent form conforming to federal and institutional guidelines.
  • The parent/guardian agrees to monitor each 10-to-20 minute treatment interval (duration depending on how long the drug solution takes to aerosolize) by remaining present in the room with, and observing, the patient.
  • Patients 7 years and older must affirm their participation via the SCHS assent procedure (explanation and signed form).

Exclusion Criteria:

  • History of life-threatening asthma exacerbation, defined as prolonged hospitalization and/or requiring treatment in an intensive care unit and/or endotracheal intubation for asthma exacerbation that would contraindicate treatment with nebulized corticosteroids.
  • Co-morbid, physician-diagnosed, airway disorder such as cystic fibrosis, tracheomalacia, bronchomalacia, or foreign body aspiration
  • Any condition presenting a contraindication to treatment with nebulized corticosteroids
  • Known hypersensitivity to budesonide nebulizer solution

For general inquiries, please contact the BMC Research Department at or 877-692-8338.

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