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 |
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.
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.
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