Impact of Anti-static Chamber/Mask
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00307970|
Recruitment Status : Completed
First Posted : March 28, 2006
Last Update Posted : September 20, 2011
To compare lung delivery of fluticasone propionate delivered by HFA-pMDI, using a conventional polycarbonate of anti-static chamber/mask in a randomized crossover design in 1-6 year old children.
Hypothesis: Anti-static chamber/mask would increase the amount of inhaled corticosteroid delivered to young children who passively inhale and cannot breath hold.
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: HFA FP MDI Device: conventional chamber/mask; anti-static chamber/mask||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Impact of an Anti-static Valved-holding Chamber on Bioavailability of Inhaled Fluticasone Propionate in Young Children With Asthma|
|Study Start Date :||April 2003|
|Study Completion Date :||September 2003|
- one-hour steady-state plasma concentration of fluticasone after each device
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00307970
|United States, Florida|
|University of Florida Asthma Research Lab|
|Gainesville, Florida, United States, 32610-0486|
|Principal Investigator:||Leslie Hendeles, PharmD||University of Florida|