- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01495442
Evaluation of a Dry Powder Aerosol Dispersion Mechanism by Radiolabeling Techniques (DPI)
January 20, 2017 updated by: William Bennett, PhD, University of North Carolina, Chapel Hill
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- University of North Carolina at Chapel Hill, CEMALB
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- healthy volunteers adults
Exclusion Criteria:
- chronic illness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: modified Handihaler DPI
|
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.
|
Placebo Comparator: standard Handihaler DPI
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1-5 minutes post inhalation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
December 12, 2011
First Submitted That Met QC Criteria
December 15, 2011
First Posted (Estimate)
December 20, 2011
Study Record Updates
Last Update Posted (Estimate)
January 24, 2017
Last Update Submitted That Met QC Criteria
January 20, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 11-1260
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adult Healthy Volunteers
-
Visirna Therapeutics HK LimitedArrowhead PharmaceuticalsNot yet recruiting
-
University of Maryland, BaltimoreVapotherm, Inc.CompletedHealthy Adult VolunteersUnited States
-
Advanced Accelerator ApplicationsAtreus Pharmaceuticals CorporationCompleted
-
University of ArizonaCompleted
-
University Hospital, AntwerpBaxter Healthcare CorporationCompletedHealthy Adult VolunteersBelgium
-
Dong-A Pharmaceutical Co., Ltd.Dong-A ST Co., Ltd.Unknown
-
Dren BioNovotechRecruitingHealthy Adult VolunteersAustralia
-
AutotelicbioCompletedHealthy Adult VolunteersKorea, Republic of
-
Göteborg UniversityCompleted
-
Linda Van EldikDuke Clinical Research Institute; Alzheimer's AssociationCompleted
Clinical Trials on modified Handihaler DPI
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited States
-
GlaxoSmithKlineCompletedAsthmaCanada, United States
-
Celon Pharma SANational Center for Research and Development, PolandCompletedMajor Depressive DisorderPoland
-
Debiopharm International SARecruitingPancreatic Ductal Adenocarcinoma (PDAC) | Colorectal Cancer (CRC) | Clear Cell Renal Cell Cancer (ccRCC)France, Australia
-
Celon Pharma SANational Center for Research and Development, PolandCompleted
-
Novartis PharmaceuticalsCompletedPulmonary Disease, Chronic Obstructive (COPD)Argentina
-
Nocion TherapeuticsCompleted
-
AlgiPharma ASAlgiPharma Australia Pty. Ltd.UnknownCystic FibrosisAustralia
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Chiesi Farmaceutici S.p.A.CompletedCOPDUnited Kingdom, Ireland