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OpenTrials
Completed

NCT Number: NCT01495442

Evaluation of a Dry Powder Aerosol Dispersion Mechanism by Radiolabeling Techniques

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.

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Key information

Conditions

Adult Healthy Volunteers

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill, CEMALB

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy volunteers adults

Exclusion criteria

  • chronic illness

Treatment and study plan

modified Handihaler DPI

Device

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

Device

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • University of Texas at Austin

Registry information

Acronym: DPI

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 20, 2011
Registry last updated
Jan 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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