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Evaluation of a Dry Powder Aerosol Dispersion Mechanism by Radiolabeling Techniques (DPI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01495442
First Posted: December 20, 2011
Last Update Posted: January 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Texas at Austin
Information provided by (Responsible Party):
William Bennett, PhD, University of North Carolina, Chapel Hill
  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
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Evaluation of a Dry Powder Aerosol Dispersion Mechanism by Radiolabeling Techniques

Further study details as provided by William Bennett, PhD, University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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.


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteers adults

Exclusion Criteria:

  • chronic illness
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: December 12, 2011
First Posted: December 20, 2011
Last Update Posted: January 24, 2017
Last Verified: January 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No