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

University of North Carolina (UNC)

Status: Completed

Conditions: Adult Healthy Volunteers

Treatments: Device: modified Handihaler DPI; Device: standard Handihaler DPI

Study type: Interventional

Funder types: Other

Identifiers

NCT01495442

11-1260

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy volunteers adults

Exclusion criteria

• chronic illness

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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6 participants in 2 patient groups, including a placebo group

modified Handihaler DPI

Active Comparator group

Treatment:

Device: modified Handihaler DPI

standard Handihaler DPI

Placebo Comparator group

Treatment:

Device: standard Handihaler DPI