Asthma, Pediatric

THIS TRIAL IS NOW CLOSED

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 mball@bmctotalcare.com

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 research@bmctotalcare.com or 877-692-8338.

Back to Clinical Research

Print