Drug Delivery Via Pressurized Metered-dose Inhaler and Valved Holding Chamber in Asthmatic Children: Determination of Delivered Dose Following Coordinated and Uncoordinated Use



Status:Completed
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:5 - 8
Updated:4/2/2016
Start Date:December 2012
End Date:June 2014
Contact:Ariel Berlinski, MD
Email:BerlinskiAriel@uams.edu
Phone:501-364-1006

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The primary objective of this study is to determine ex vivo the amount of fluticasone
deposited onto a filter (delivered dose) interposed between the OptiChamber Diamond VHC
mouthpiece and the subject's mouth during coordinated and uncoordinated actuation/inhalation
maneuver.


Inclusion Criteria:

- • Asthmatic children between the ages of 5 and 8 followed at Arkansas Children's
Hospital.

- The subjects must be available to complete the study.

- The subject's parent(s) and/or the subject's legal guardian must provide written
informed consent to participate in the study.

- The subject must provide assent when older than 7 years old.

- The subjects should have used a pMDI VHC previously and be able to use a VHC
with mouthpiece.

- The subjects should have been prescribed fluticasone or another inhaled
corticosteroid delivered via a pMDI VHC combination.

- Clinically stable asthma.

- Cooperative, i.e., subject should be able to follow and understand instructions.

- The subject must satisfy the study investigator about his/her fitness to
participate in the study.

Exclusion Criteria:

- Clinically significant respiratory disease in the previous 4 weeks.

- Participation in any other clinical trial in the previous 4 weeks.

- Lack of cooperation, subject cannot follow and understand instructions.
We found this trial at
1
site
1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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