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.