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

This study has been completed.
Sponsor:
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: July 17, 2013
Last verified: July 2013
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 17, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 28, 2014