Drug Delivery Via Pressurized Metered-dose Inhaler and Valved Holding Chamber in Asthmatic Children: Determination of Delivered Dose Following Coordinated and Uncoordinated Use
Completed
Conditions studied: Asthma
In brief
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 Valved Holding Chamber (VHC) mouthpiece and the subject's mouth during coordinated and uncoordinated actuation/inhalation maneuver.
Key facts
- Study ID
- NCT01714063
- Run by
- Philips Respironics
- People needed
- 34
- Starts
- 2012-12-01
- Expected to finish
- 2014-07-01
- Last updated by the study team
- 2019-04-24
Who can join
Age: 5 and older, up to 8. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- • 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.
You may not qualify if…
- 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.
Where it is running
- Arkansas Children's Hospital — Little Rock, Arkansas, United States
Full record on ClinicalTrials.gov
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