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Funhaler spacer: improving adherence withoutcompromising delivery P M Watt, B Clements, S G Devadason, G M Chaney. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
A novel asthma spacer device, the “Funhaler”, incorpo- Our standard methodology17 was used for comparison of the rates incentive toys which are isolated from the main particle size distribution of salbutamol (100 µg/actuation; inspiratory circuit by a valve. Here we show that its use Ventolin, GSK) and beclomethasone dipropionate (BDP) (50 µg/actuation; Becotide, GSK) delivered via pMDI through two Improved adherence combined with satisfactory delivery detergent coated small volume polycarbonate spacers (235 ml characteristics suggest that the Funhaler may be useful for Breath-A-Tech; 225 ml Funhaler). Particle size distribution and total drug delivery was measured using a multistage liq-uid impinger (MSLI; Copley, Nottingham, UK) with acalibrated inhalation flow of 60 l/min. The pMDI was shakenvigorously for 30 seconds prior to actuations, and the first two Poor adherence to prescribed frequency and technique actuationswerewasted.Tensingleactuationswereintroduced remains a major problem for paediatric asthmatics on into the MSLI. The pMDI was shaken vigorously for five inhaled medication. Rates of compliance for offering seconds between each actuation. The aerosol generated by the medication regularly to asthmatic children range from 30% to pMDI was drawn through the MSLI with the entraining air 70%, while paediatric compliance rates for correct pressurised flow. Droplets were deposited on the actuator, “throat”, or one metered dose inhaler (pMDI) technique range from 39% to of four stages of the device. The location of particle deposition 67%.1–6 Unfortunately, adherence does not necessarily improve was determined by the aerodynamic size of the particle. The with rising severity of illness,7–9 and physicians do not always sizes of particles depositing on stages 1, 2, 3, and 4 (absolute filter) were >13 µm, 6.8–13 µm, 3.1–6.8 µm, and <3.1 µm, Unfortunately drug deposition studies have shown that respectively. The actuator, spacer, throat, and stages of the crying impedes drug delivery to children11 12 and poor MSLI were washed with HPLC grade methanol (BDP, 50 ml technique frequently leads to reduced drug delivery to the methanol; salbutamol, 45 ml methanol + 5 ml 0.1M NaOH).
patient. For example, a study of 55 moderate to severe The absorbance (salbutamol 246 nm; BDP 238 nm) of each asthmatic children found that only 73% had technique which sample was measured in duplicate with a UV spectropho- would allow any drug delivery.5 Recent studies have confirmed tometer. Data were taken from three experiments for each these alarmingly low rates of adherence in children. A video condition and standard errors (SE) were calculated.
based study found that only half of the children surveyed hadappropriate pMDI technique.6 The consequences of poor adherence are serious. Irregular treatment and poor inhalation technique are linked to more The Funhaler toy circuit design: harnessing play for hospitalisations and increased morbidity. For example, one study showed 14% compliance to offering medication to chil- In an attempt to address the adherence problem from a new dren with asthma exacerbations versus 68% of children with- perspective (that of the child), a novel low volume spacer device, the “Funhaler” was designed. This device incorporates The reasons suggested for such poor compliance are varied, a number of features to distract the attention of children from including ignorance, fear, boredom, forgetfulness, and the drug delivery event itself and to provide a means of self apathy.9 14 15 Education can significantly improve adherence of reinforcing the use of effective technique. Figure 1 shows the asthmatic patients but is decreasingly effective in younger design of the Funhaler, with an inset showing a 4 year old children, and a more holistic approach may be necessary to child using the device. The Funhaler design differs from previ- tackle this difficult age group.9 Especially in children it is likely ous efforts to make spacers appealing to children in several that an interplay of adherence considerations with aerosol major respects. Firstly, it isolates incentive toys (spinner and output factors can influence clinical outcomes (see Cole16 for whistle) in a separate branch to the standard inhalation circuit, placing them outside the expiratory valve of the spacerto avoid problems of contamination and interference of drug delivery. Secondly, the design of the toys themselves ensures sufficient inspiratory resistance to minimise entrainment of A total of 32 children (10 male, 22 female; age range 1.5–6 inspired air through the toy circuit. Thirdly, the design years, mean age 3.2 years; average duration of asthma of 2.2 attempts to link the optimal function of the toys to deep tidal years) prescribed drugs delivered by pMDI and spacer were breathing pattern conducive to effective medication. Finally, recruited into the study with informed consent. Matchedquestionnaires were completed with 27–32 valid responses toeach pair of questions being collected after sequential use of . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
the Breath-a-Tech (Scott-Dibben, Australia) and Funhaler Abbreviations: BDP, beclomethasone dipropionate; MSLI, multistage (InfaMed, Australia, www.funhaler.com) spacer device for liquid impinger; pMDI, paediatric metered dose inhaler; SE, standard the design of the Funhaler anticipates the potential for bore- are comparable to conventional devices. In addition to helping dom of children with particular incentive toys in its modular with problems of breath coordination, spacer devices can help arrangement which would allow the replacement of the to minimise oropharyngeal deposition by releasing a higher incentive toy module with a range of different toys.
proportion of fine aerosol droplets (<6.8 mm), particles whichwe refer to here as the “respirable dose”. For this study we Funhaler use associated with improved measures of used prototypes of the Funhaler which were made of polycar- bonate, the material intended for the production units of the We have recently completed a study of the effect of the Funhaler on measures of paediatric adherence in the home Overall no significant differences were observed between setting. In this survey, the details of which are to be reported the Funhaler and the Breath-a-tech spacer for delivery of the elsewhere, use of the Funhaler was associated with improved respirable particle fractions (compare percentage delivered parental and child compliance. For example, when surveyed at dose of 3.1–6.8 µm and <3.1 µm between the two devices; see random, 38% more parents were found to have medicated table 1). The apparently slightly higher ex-spacer output of their children the previous day when using the Funhaler, particles of the smaller size range (particularly <3.1 µm) compared to their existing small volume spacer device (22/27 observed with the Funhaler was compensated by lower losses versus 16/27, respectively; p = 0.016), and 60% more children overall from within the conventional spacer device itself (data took the recommended four or more cycles per aerosol deliv- not shown), resulting in a comparable percentage of the ery (24/30 versus 15/30; p = 0.02) when using the Funhaler ex-actuator dose being delivered from both devices.
Given the large variance in compliance of children to the prescribed frequency and technique for asthma medication, it No significant difference in aerosol output from is likely that compliance to prescribed use may be more influ- ential than minor variations in the delivery characteristics of Here we describe a complementary comparison of the the spacer per se. Indeed in two recent studies, the variation in performance of the Funhaler (InfaMed Ltd, Australia) with delivery from spacer devices in daily life is considerably the most prevalent small volume spacer device in Australia, greater than that predicted from in vitro studies,6 18 and some the Breath-a-tech (Scott-Dibben, Australia; analogous in of this variability may be attributed to problems of adherence.
design to the Optichamber device, Respironics, USA) to assess Based on the results presented here and proven effects of whether the aerosol delivery characteristics of the Funhaler spacer use on morbidity of children,19 we hypothesise that use Extrafine particle fraction (<3.1 µm) Extrafine particle fraction (<3.1 µm) No significant differences between spacers for either salbutamol or BDP (p>0.05).
of the Funhaler could be translated to improved measures of 6 Janssens HM. Aerosol delivery from spacers in wheezy infants: a daily clinical outcome. Therefore the work presented here provides life study. Eur Respir J 2000;16:850–6.
7 Walsh LJ, Wong CA, Cooper S, et al. Morbidity from asthma in relation a basis for future efficacy studies to test the hypothesis that to adherence. Thorax 1999;54:296–300.
use of functional incentive devices such as the Funhaler may 8 Kamps AW, Ewijk B, Roorda RJ, et al. Poor inhalation technique, even after inhalation instructions in children with asthma. Pediatr Pulmonol2000;29:39–42.
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9 Chapman KR, Walker L, Cluley S, et al. Improving patient compliance with asthma therapy. Respir Med 2000;94:2–9.
10 Bauman A, Cooper C, Bridges-Webb C, et al. Asthma management P M Watt, TVW Telethon Institute for Child Health Research and Centre and morbidity in Australian general practice: the relationship between for Child Health, University of Western Australia patient and doctor estimates. Respir Med 1995;89:665–72.
B Clements, G M Chaney, Princess Margaret Hospital for Children, 11 Tal A, Golan H, Grauer N, et al. Deposition pattern of radiolabelled Western Australia GPO, Box D184, Perth, WA, 6840 Australia salbutamol inhaled from a metered-dose inhaler by means of a spacer S G Devadason, Department of Paediatrics, University of Western with mask in young children with airway obstruction. J Pediatr Australia, Princess Margaret Hospital, Roberts Road, Subiaco, WA 12 Iles R, Lister P, Edmunds AT. Crying significantly reduces absorption of aerosolised drug in infants. Arch Dis Child 1999;81:163–5.
Correspondence to:Dr P Watt, TVW Telethon Institute for Child Health Research, 100 Roberts 13 Milgrom H, Bender B, Ackerson L, et al. Noncompliance and treatment Road, Subiaco, WA 6008, PO Box 855, West Perth, WA 6872; failure in children with asthma. J Allergy Clin Immunol 1996;98;1051–7.
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16 Cole CH. Special problems in aerosol delivery: neonatal and pediatric 1 Smith NA, Seale JP, Shaw S. Medication compliance in children with considerations. Respir Care 2000;45:646–51.
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17 Wildhaber JH, Devadason SG, Eber E, et al. Effect of electrostatic 2 Gibson NA, Ferguson AE, Aitchison TC, et al. Compliance with inhaled asthma medication in preschool children. Thorax 1995; charge, flow, delay and multiple actuations on the in vitro delivery of 3 Dekker FW, Dieleman FE, Kaptein AA, et al. Compliance with salbutamol from different small volume spacers for infants. Thorax pulmonary medication in general practice. Eur Respir J 1993;6:886–90.
4 Rand CS, Wise RA. Measuring adherence to asthma medication 18 Janssens HM. Variability of aerosol delivery via spacer devices in regimens. Am J Respir Crit Care Med 1994;149:S69–76.
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5 Celano M, Geller RJ, Phillips KM, et al. Treatment adherence among 19 Cunningham SJ, Crain EF. Reduction of morbidity in asthmatic children low-income children with asthma. J Paediatr Psychol 1998;23:345–9.
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