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Aerosol delivery to young children by pMDI-spacer: is facemask design important?
José Esposito-Festen1, Bahar Ates, Frans van Vliet
1Department of Pediatrics, Division of Respiratory Medicine, Erasmus University Medical Center/Sophia Children's Hospital, Rotterdam, The Netherlands.
Insights
The Galemed facemask improved budesonide drug delivery to young children with recurrent wheeze using a spacer. Mask design impacts drug delivery, but dose variability depends on child cooperation.
Area of Science:
- Pediatric Pulmonology
- Respiratory Drug Delivery
- Medical Device Evaluation
Background:
- Effective delivery of inhaled medications is crucial for managing recurrent wheeze in young children.
- Facemask design and patient cooperation significantly influence aerosol deposition in the lungs.
- Optimizing inhaler-spacer systems is essential for improving treatment outcomes.
Purpose of the Study:
- To evaluate the influence of different facemask designs on budesonide drug delivery via a spacer in young children with recurrent wheeze in a daily-life setting.
- To compare the efficacy of AstraZeneca, Galemed, and Hans Rudolph facemasks when used with the NebuChamber spacer.
- To assess the impact of facemask design and child cooperation on drug delivery efficiency and variability.
Main Methods:
- A 4-week randomized crossover study involving 24 children (7-23 months) with recurrent wheeze.
- Children used AstraZeneca, Galemed, and Hans Rudolph facemasks with the NebuChamber spacer twice daily at home for 7 consecutive days each.
- Budesonide aerosol was collected on filters between the spacer and facemask to quantify delivered dose; parent cooperation scores and video recordings evaluated administration.
Main Results:
- The Galemed facemask demonstrated significantly higher mean drug delivery (47% of nominal dose) compared to AstraZeneca (39%) and Hans Rudolph (42%) masks (p < 0.045).
- Within-subject dose variability, measured as coefficient of variation, was not significantly different between the masks (30-37%).
- Decreased child cooperation was strongly associated with increased dose variability across all tested facemask designs (p = 0.007).
Conclusions:
- The Galemed facemask enhances budesonide drug delivery to young children with recurrent wheeze when used with the NebuChamber spacer.
- Facemask design plays a significant role in optimizing aerosol delivery efficiency.
- Child cooperation is a primary determinant of dose variability, irrespective of facemask design, highlighting the importance of administration technique.
Abstract:
This study aimed at identifying in a daily-life setting the influence of facemask design on drug delivery via a spacer to young children. In a 4-week randomized crossover study, 24 children (7-23-months old) with recurrent wheeze tested the AstraZeneca, Galemed, and Hans Rudolph facemask combined with the NebuChamber at home. Each mask was tested twice daily for seven consecutive days. Filters positioned between the NebuChamber and facemask trapped the budesonide aerosol (200 microg, Pulmicort). Parents were asked to score the child's degree of cooperation during administration on diary cards. The administration procedure was evaluated through video recordings. Mean filter dose (standard deviation (s.d.)), expressed as % of nominal dose, was 39% (14), 47% (12), and 42% (11) for the AstraZeneca, the Galemed and the Hans Rudolph mask, respectively. Irrespective of the degree of cooperation, the Galemed mask gave significantly higher mean filter doses than the other masks (level of significance) (p < 0.045). Median (range) within-subject dose variability, expressed, as coefficient of variation (CV), was 37% (19-255), 32% (9-114), and 30% (9-115) for the AstraZeneca mask, the Galemed mask and the Hans Rudolph mask, respectively, not significant. Dose variability increased with decreasing cooperation for all three masks (p = 0.007). Drug delivery to young children with recurrent wheeze by means of the NebuChamber can be enhanced using the Galemed facemask. Dose variability seems to be independent of facemask design but mainly depends on cooperation.
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