Evaluation of a Dry Powder Aerosol Dispersion Mechanism by Radiolabeling Techniques
DPI
1 other identifier
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 12, 2011
CompletedFirst Posted
Study publicly available on registry
December 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedJanuary 24, 2017
January 1, 2017
6 months
December 12, 2011
January 20, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Fractional delivery of dry powder to the lung
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.
1-5 minutes post inhalation
Study Arms (2)
modified Handihaler DPI
ACTIVE COMPARATORstandard Handihaler DPI
PLACEBO COMPARATORInterventions
subjects randomized to receive 1 inhaled dose on 2 separate days, each dose delivered 2-3 days apart. The radiolabeled albuterol drug powder will be dispersed from either the DET bead-HandiHaler prototype or via the established HandiHaler device standard with the lactose-albuterol formulation provided to us by the sponsor.
subjects randomized to receive 1 inhaled dose on 2 separate days, each dose delivered 2-3 days apart. The radiolabeled albuterol drug powder will be dispersed from either the DET bead-HandiHaler prototype or via the established HandiHaler device standard with the lactose-albuterol formulation provided to us by the sponsor.
Eligibility Criteria
You may qualify if:
- healthy volunteers adults
You may not qualify if:
- chronic illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of North Carolina at Chapel Hill, CEMALB
Chapel Hill, North Carolina, 27599, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
December 12, 2011
First Posted
December 20, 2011
Study Start
December 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
January 24, 2017
Record last verified: 2017-01