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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: Completed NA study of Adult Healthy Volunteers, sponsored by University of North Carolina, Chapel Hill.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2011-12 |
| Est. Completion | 2012-06 |
| Phase | NA |
What the finished NCT01495442 record still lists
NCT01495442 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01495442's enrollment target sits among peer trials
6 1983rd of 2000 higher than 13 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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