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NCT01495442 · ClinicalTrials.gov registry record · NA

Evaluation of a Dry Powder Aerosol Dispersion Mechanism by Radiolabeling Techniques

A NA study of Adult Healthy Volunteers, sponsored by University of North Carolina, Chapel Hill.

Completed
Registry status
NA
Development phase
6
Enrollment target
1
Study location

NCT01495442 is a NA study of Adult Healthy Volunteers that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 6 participants. The trial reports 1 study location across 1 state.

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The verdict

NCT01495442, a NA study of Adult Healthy Volunteers, has completed, sponsored by University of North Carolina, Chapel Hill.

COMPLETED
Registry status
NA
Development phase
6 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Interventions

  • DEVICE modified Handihaler DPI
  • DEVICE standard Handihaler DPI

Study Locations (1)

North Carolina

  • University of North Carolina at Chapel Hill, CEMALB - Chapel Hill

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2011-12
Est. Completion 2012-06
Phase NA

What the Registry Record Tells You About NCT01495442

The ClinicalTrials.gov registry entry for NCT01495442 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Adult Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which modified Handihaler DPI is the first listed.

NCT01495442 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT01495442 about?

NCT01495442 is a clinical study titled "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 modifi...

What is the current status of trial NCT01495442?

This trial is currently completed. It is a NA study. The enrollment target is 6 participants. The study started on 2011-12. Estimated completion is 2012-06.

What conditions does trial NCT01495442 study?

This clinical trial studies the following conditions: Adult Healthy Volunteers.

What interventions are being tested in trial NCT01495442?

The interventions under investigation include: modified Handihaler DPI (DEVICE), standard Handihaler DPI (DEVICE).

Who is sponsoring clinical trial NCT01495442?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01495442 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.