Evaluation of a Dry Powder Aerosol Dispersion Mechanism by Radiolabeling Techniques
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Fractional delivery of dry powder to the lung
Study Overview
Brief Summary
The primary objective is to admix a radiolabel with albuterol sulphate for incorporation into the Handihaler® device for inhalation studies. This will allow for the investigators to determine the regional lung deposition of drug inhaled from the standard Handihaler® device compared to a novel modification of the device to provide more effective dispersion and aerosolization of the coated albuterol powder. The new mechanism of action for proof-of-concept testing consists of a bead (5.1 mm; expanded polystyrene foam) coated with drug powder, as opposed to the standard lactose formulation-filled capsule.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •healthy volunteers adults
Exclusion Criteria
- •chronic illness
Arms & Interventions
modified Handihaler DPI
Intervention: modified Handihaler DPI (Device)
standard Handihaler DPI
Intervention: standard Handihaler DPI (Device)
Outcomes
Primary Outcomes
Fractional delivery of dry powder to the lung
Time Frame: 1-5 minutes post inhalation
To compare the in vivo performance,i.e. the fraction of drug loaded in device that is delivered to the lung, of the novel system in comparison with a standard marketed dry powder inhaler (DPI) using radio-imaging techniques. The fraction delivered to the lung will be determined by gamma camera imaging of the lungs following inhalation of the radiolabeled powder from the standard vs. new device.
Secondary Outcomes
No secondary outcomes reported
Investigators
William Bennett, PhD
Professor of Medicine
University of North Carolina, Chapel Hill