Drug Delivery in Asthmatic Children Following Coordinated and Uncoordinated Inhalation Maneuvers: A Randomized Crossover Trial

BerlinskiAriel,; HollenDirk, von; HatleyRoss, H M; HardakerLucy, E A; NikanderKurt,

doi:10.1089/jamp.2016.1337

Cited by 7 publications

(11 citation statements)

References 12 publications

(19 reference statements)

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“…Before every actuation, the pMDI was shaken vigorously five times. The pMDI was then inserted into the VHC and immediately actuated at the start of inhalation . During each measurement, the valve movement was constantly assessed by visual inspection.…”

Section: Methodsmentioning

confidence: 99%

“…During each measurement, the valve movement was constantly assessed by visual inspection. Salbutamol was left to accumulate in the filter for eight breathing cycles, which has been shown to be sufficient to empty even larger volume VHCs . The filters were sealed with Parafilm M (Bemis Company, Inc., Oshkosh, WI) until analysis of the drug content.…”

Section: Methodsmentioning

confidence: 99%

“…The pMDI was then inserted into the VHC and immediately actuated at the start of inhalation. 27 During each measurement, the valve movement was constantly assessed by visual inspection. Salbutamol was left to accumulate in the filter for eight breathing cycles, which has been shown to be sufficient to empty even larger volume VHCs.…”

Section: Measurement Protocolsmentioning

confidence: 99%

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In vitro drug delivery performance of five valved holding chambers with and without facemasks

Csonka

Lehtimäki

2019

Pediatric Pulmonology

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Background Valved holding chambers (VHCs) are essential for efficient pulmonary delivery of inhaled medication in preschool children. The numerous devices in the market vary in material, aerodynamic characteristics, volume, valve properties, and mask design. Drug delivery is affected by the VHC characteristics as well as by the age and breathing pattern of the child. Methods We measured the drug delivery efficacy of five VHCs widely available in the market, evaluated the effect of facemasks and tested the differences between manufacturing lots. A breathing simulator was used to mimic normal (respiratory rate [RR] 25/minute and tidal volume (VT) 200 mL) and obstructive (RR 50/minute and VT 50 mL) breathing of infants and toddlers. Results Salbutamol output was significantly higher with a normal breathing pattern compared to the obstructive breathing pattern in most VHCs. Without masks, the differences in the median in vitro filter doses of salbutamol were mainly from 2 to 10‐fold among different types of VHCs. With masks, there was a greater than 20‐fold difference in drug delivery capacity between the most and least effective devices. Most VHCs had a notable variation of performance between individual devices from different lots within the same brand. Conclusions There was an extreme variation in the salbutamol delivery performance among different types of VHCs for both normal and obstructive pediatric breathing patterns with and without masks. This magnitude of performance variability can have significant and unpredictable clinical implications.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Measurement Protocolsmentioning

confidence: 99%

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In vitro drug delivery performance of five valved holding chambers with and without facemasks

Csonka

Lehtimäki

2019

Pediatric Pulmonology

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“…The study was approved by the University of Arkansas institutional review board (approval 137456) and was registered at ClinicalTrials.gov (registration NCT01714063). 6 Parents provided consent, and children 7 y or older also provided assent. All procedures were performed by the principal investigator.…”

Section: Methodsmentioning

confidence: 99%

“…5 In a recent study in children with asthma, we compared the dose of fluticasone emitted from a valved holding chamber when pMDI actuation was coordinated with the onset of inhalation or when the pMDI actuation was uncoordinated, and the pMDI was actuated during exhalation. 6 In that study, a monitoring device was used to record shaking and actuation of the device. Therefore, we were able to evaluate the effect of a delay between shaking and actuation on fluticasone output.…”

Section: Introductionmentioning

confidence: 99%

Delay Between Shaking and Actuation of a Hydrofluoroalkane Fluticasone Pressurized Metered-Dose Inhaler

et al. 2017

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Delays between shaking and actuating a corticosteroid suspension pMDI resulted in an increase in the emitted dose of the second actuation following the delay. This can be a common occurrence when doses are administered by a caregiver to a patient via a holding chamber. This should be addressed by practitioners educating patients and parents on proper inhaler use. (ClinicalTrials.gov registration NCT01714063.).

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Antistatic treatment and salbutamol dosing have variable effect on drug delivery of valved holding chambers

Csonka

Lehtimäki

2019

Pulmonary Pharmacology & Therapeutics

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Aims: Our aim was to evaluate whether the number of puffs or antistatic treatment have significant effect on drug delivery of six different valved holding chambers (VHCs). Methods: We used simulated paediatric breathing pattern with 25/min frequency and 200 ml tidal volume. When comparing the effect of antistatic treatment, we used 100 µg of salbutamol (one puff Ventolin Evohaler 100 µg/dos) actuated into each VHC before and after detergent wash. When comparing the effect of one or two puffs (100 vs. 200 µg), all VHCs were washed prior to the measurements. Results: All VHC were significantly affected by antistatic treatment. Washing improved drug delivery of four VHCs (1.3-2.2 fold increase in median filter dose) but had an opposite effect in two devices (54-61% decrease). The effect of dose doubling resulted in a 2.03 to 2.93 fold increase on filter dose in two VHCs. Four out of the six VHC showed significantly poorer performance with two puffs as opposed to one puff (ratio of two puffs to one puff varied between 1.19-1.77). Conclusion: VHCs marketed as antistatic are significantly affected by antistatic treatment. To ensure optimal drug delivery, salbutamol should be actuated to VHCs one puff at a time. Each VHC brand has its unique characteristic that affects drug delivery in a way that cannot be generalised to another VHC. There is a need for universal standardisation of VHCs. Key Notes: Valved holding chambers (VHCs) that are marketed as antistatic are significantly affected by antistatic treatment. Multiple actuations before inhalation tend to decrease the drug delivery efficacy of VHCs. Each VHC brand has its unique characteristic that affects drug delivery in a way that cannot be generalised to another VHC. There is a need for comprehensive and financially independent testing and standardisation of VHCs.

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Drug Delivery in Asthmatic Children Following Coordinated and Uncoordinated Inhalation Maneuvers: A Randomized Crossover Trial

Abstract: Actuating the pMDI into a small-volume nonelectrostatic VHC during exhalation reduced by 11% the amount of fluticasone captured at the exit of the VHC. Asthmatic children (5-8 years old) need three or less breaths to empty the small-volume VHC (NCT01714063).

Cited by 7 publications

References 12 publications

In vitro drug delivery performance of five valved holding chambers with and without facemasks

In vitro drug delivery performance of five valved holding chambers with and without facemasks

Delay Between Shaking and Actuation of a Hydrofluoroalkane Fluticasone Pressurized Metered-Dose Inhaler

Antistatic treatment and salbutamol dosing have variable effect on drug delivery of valved holding chambers

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