Evaluation of a Dry Powder Aerosol Dispersion Mechanism by Radiolabeling Techniques

Adult Healthy Volunteers Clinical Trial

— DPI  

Official title:

Evaluation of a Dry Powder Aerosol Dispersion Mechanism by Radiolabeling Techniques

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01495442
• Other study ID #: 11-1260
• Status: Completed
• Phase: N/A
• First received: December 12, 2011
• Last updated: January 20, 2017
• Start date: December 2011
• Est. completion date: June 2012

Study information

• Verified date: January 2017
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• healthy volunteers adults

Exclusion Criteria:

• chronic illness

Related Conditions & MeSH terms

• Adult Healthy Volunteers

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill, CEMALB	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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