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

Study Overview
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Brief Summary
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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 Valved Holding Chamber (VHC) mouthpiece and the subject's mouth during coordinated and uncoordinated actuation/inhalation maneuver.

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

Conditions
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Asthma

Intervention / Treatment
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* Device: Pressurized Metered-Dose Inhaler


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Age 5-6.5<br>Group 1 will consist of 16 children aged 5-6.5 years | Device: Pressurized Metered-Dose Inhaler<br>* Pressurized Metered-Dose Inhaler<br>|
| Aged 6.6- 8 years<br>Group 2 will consist of 16 children aged 6.6- 8 years | Device: Pressurized Metered-Dose Inhaler<br>* Pressurized Metered-Dose Inhaler<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delivered Dose of Fluticasone (on the Filter) | This is a measure of the the amount of fluticasone deposited onto a filter (delivered dose) during coordinated and uncoordinated actuation/inhalation maneuver. The coordinated maneuver occurs when the firing of the fluticasone is coordinated with the inhalation of the patient . An uncoordinated maneuver occurs when the firing of the fluticasone is coordinated with the exhalation of the patient. | Day 1 | 
| Delivered Dose of Fluticasone (on the Filter) Comparing Coordinated and Uncoordinated Maneuvers | This is a measure of the the amount of fluticasone deposited onto a filter (delivered dose) during coordinated and uncoordinated actuation/inhalation maneuver. The coordinated maneuver occurs when the firing of the fluticasone is coordinated with the inhalation of the patient . An uncoordinated maneuver occurs when the firing of the fluticasone is coordinated with the exhalation of the patient. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inspiratory Peak Flow | Inspiratory peak flow is a person's maximum speed of inspiration, as measured with a peak flow meter, a small, hand-held device used to monitor a person's ability to breathe in air. This study compared the inspiratory peak flows of all participants between the coordinated and uncoordinated maneuvers. | Day 1 | 
| Inspiratory Tidal Volume | Inspiratory tidal volume is a person's lung volume representing the normal volume of air displaced between normal inhalation and exhalation when extra effort is not applied. In a healthy, young human adult, tidal volume is approximately 500 mL per inspiration or 7 mL/kg of body mass. This study compared the inspiratory tidal volume of all participants between the coordinated and uncoordinated maneuvers. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VHC, asthma, pediatric, metered dose inhaler, valved holding chamber, pMDI