Evaluation of a Dry Powder Aerosol Dispersion Mechanism by Radiolabeling Techniques (DPI)
This study has been completed.
Sponsor:
University of North Carolina, Chapel Hill
Collaborator:
University of Texas at Austin
Information provided by (Responsible Party):
William Bennett, PhD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01495442
First received: December 12, 2011
Last updated: May 6, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Adult Healthy Volunteers |
Device: modified Handihaler DPI Device: standard Handihaler DPI |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science |
| Official Title: | Evaluation of a Dry Powder Aerosol Dispersion Mechanism by Radiolabeling Techniques |
Further study details as provided by University of North Carolina, Chapel Hill:
Primary Outcome Measures:
- Fractional delivery of dry powder to the lung [ Time Frame: 1-5 minutes post inhalation ] [ Designated as safety issue: No ]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.
| Enrollment: | 6 |
| Study Start Date: | December 2011 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: modified Handihaler DPI |
Device: modified Handihaler DPI
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.
|
| Placebo Comparator: standard Handihaler DPI |
Device: standard Handihaler DPI
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| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- healthy volunteers adults
Exclusion Criteria:
- chronic illness
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01495442
Locations
| United States, North Carolina | |
| University of North Carolina at Chapel Hill, CEMALB | |
| Chapel Hill, North Carolina, United States, 27599 | |
Sponsors and Collaborators
University of North Carolina, Chapel Hill
University of Texas at Austin
More Information
No publications provided
| Responsible Party: | William Bennett, PhD, Professor of Medicine, University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT01495442 History of Changes |
| Other Study ID Numbers: | 11-1260 |
| Study First Received: | December 12, 2011 |
| Last Updated: | May 6, 2013 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on June 18, 2013