Evaluation of a Dry Powder Aerosol Dispersion Mechanism by Radiolabeling Techniques

Not Applicable

Completed

• Conditions: Adult Healthy Volunteers
• Interventions: Device: modified Handihaler DPI; Device: standard Handihaler DPI

• Registration Number: NCT01495442
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-12
• Study First Submitted QC: 2011-12-15
• Study First Posted: 2011-12-20
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-20
• Last Update Posted: 2017-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• healthy volunteers adults

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Exclusion Criteria

• chronic illness

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
modified Handihaler DPI	modified Handihaler DPI	-
standard Handihaler DPI	standard Handihaler DPI	-

Primary Outcome Measures

Name	Time	Method
Fractional delivery of dry powder to the lung	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.

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill, CEMALB; 🇺🇸 Chapel Hill, North Carolina, United States