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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Age 5-6.5 | Group 1 will consist of 16 children aged 5-6.5 years |
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| Aged 6.6- 8 years | Group 2 will consist of 16 children aged 6.6- 8 years |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pressurized Metered-Dose Inhaler | Device | Pressurized Metered-Dose Inhaler |
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| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement Residual Amount of Drug (Fluticasone) Deposited Within the OptiChamber Diamond VHC | Collect the residual amount of drug (fluticasone) deposited within the OptiChamber Diamond VHC by washing the internal surfaces of the VHC and the Pressurized Metered Dose Inhaler (pMDI) boot | Day 1 |
Inclusion Criteria:
• Asthmatic children between the ages of 5 and 8 followed at Arkansas Children's Hospital.
Exclusion Criteria:
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40 subjects aged 5-8 diagnosed with asthma
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| Name | Affiliation | Role |
|---|---|---|
| Ariel Berlinski, MD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29162718 | Derived | Berlinski A, von Hollen D, Pritchard JN, Hatley RH. Delay Between Shaking and Actuation of a Hydrofluoroalkane Fluticasone Pressurized Metered-Dose Inhaler. Respir Care. 2018 Mar;63(3):289-293. doi: 10.4187/respcare.05782. Epub 2017 Nov 21. | |
| 27977309 | Derived | Berlinski A, von Hollen D, Hatley RHM, Hardaker LEA, Nikander K. Drug Delivery in Asthmatic Children Following Coordinated and Uncoordinated Inhalation Maneuvers: A Randomized Crossover Trial. J Aerosol Med Pulm Drug Deliv. 2017 Jun;30(3):182-189. doi: 10.1089/jamp.2016.1337. Epub 2016 Dec 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pressurized Metered-Dose Inhaler | All participants that were consented to use the Pressurized Metered-Dose Inhaler in this study were considered. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All participants that were consented to the study were considered. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Height | Mean | Standard Deviation | centimeters |
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| Weight | Mean | Standard Deviation | kilograms |
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| Time Using Valved Holding Chamber | Mean | Standard Deviation | years |
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| Previous Mouthpiece Experience | Mean | Standard Deviation | percentage of participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 99% Confidence Interval | Percent filter dose of fluticasone | Day 1 |
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| Primary | 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. | 1 participant was excluded from the filter data because they were an outlier | Posted | Mean | 99% Confidence Interval | Percent filter dose of fluticasone | Day 1 |
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| Secondary | 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. |
| Posted | Mean | 99% Confidence Interval | L/min | Day 1 |
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| Secondary | 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. |
| Posted | Mean | 99% Confidence Interval | mL | Day 1 |
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| Other Pre-specified | Measurement Residual Amount of Drug (Fluticasone) Deposited Within the OptiChamber Diamond VHC | Collect the residual amount of drug (fluticasone) deposited within the OptiChamber Diamond VHC by washing the internal surfaces of the VHC and the Pressurized Metered Dose Inhaler (pMDI) boot | This is a measure of an inhaler study, not a nebulizer study. Therefore this data was not collected or analyzed as it would not be applicable to this type of study. | Posted | Day 1 |
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1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Study Participants | All participants that were consented to the study were considered. | 0 | 34 | 0 | 34 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ariel Perlinkski MT | Department of Pediatrics UAMS/COM | berlinskiariel@uams.edu |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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