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PubMed2000

[A new spacer, Babyhaler, for BDP inhalation therapy in severe infantile asthma].

Recently, it has been recognized that airway inflammation is the most important pathogenesis of bronchial asthma, and inhaled corticosteroids therapy is effective for childhood asthma. However, using metered dose inhalers (MDI) of beclomethasone dipropionate (BDP) is difficult for infants. In this study, we administered BDP inhalation therapy with a new spacer, Babyhaler, for five cases of early childhood with severe infantile asthma that we could not control even by combination of theophylline round the clock (RTC) therapy and disodium cromoglycate (DSCG) + beta 2 stimulant (beta 2) regular use. We compared symptom score of asthma attack between the pre-treatment period (prior 2 weeks) and post-treatment period (following 8 weeks) of BDP inhalation therapy with Babyhaler. As a result, symptom score decreased significantly within 4 weeks after treatment of BDP with Babyhaler as compared with the score before treatment of BDP. These findings suggest that Babyhaler is useful for BDP inhalation therapy in infantile asthma.

Administration, Inhalation↗
PubMed1984

The efficacy of drug delivery by a pear-shaped spacer and metered dose inhaler.

The efficacy of terbutaline delivered via a 750 ml spacer device (Nebuhaler) compared with a metered dose inhaler alone was studied by means of an open cross-over trial in eight patients with stable asthma. The FEV1 and FVC response curves with cumulative doses up to 8 mg were shifted significantly to the left using the device, whilst side effects were not significantly increased. These results indicate that the spacer significantly improves aerosol drug delivery from a pressurized inhaler, even in patients whose inhalation technique was considered adequate.

Adult↗
PubMed1998

Lung deposition of budesonide from a pressurized metered-dose inhaler attached to a spacer.

The absolute systemic availability and pulmonary deposition of budesonide inhaled from a pressurized metered-dose inhaler (pMDI) attached to a Nebuhaler spacer was determined in 15 healthy subjects. The study was of an open cross-over design. Each subject randomly received three single doses of budesonide on separate days: 0.5 mg given intravenously and 1.0 mg (0.2 mg x 5) by inhalation from a pMDI with a Nebuhaler, with or without concomitant oral charcoal intake to prevent gastrointestinal absorption. Charcoal intake did not significantly affect the systemic availability or deposition of budesonide. The systemic availability was 36+/-14% (metered dose, mean+/-SD) with charcoal and 35+/-10% without. The pulmonary deposition was 36+/-14% with charcoal and 34+/-11% without. Erroneous administration, in which the canister was shaken only before the first of the five actuations, halved the systemic availability. In conclusion, the pulmonary deposition of budesonide from a pressurized metered-dose inhaler with Nebuhaler is high under optimum conditions. The small discrepancy between the systemic availability and pulmonary deposition indicates that the contribution from deposition in the oropharynx and subsequent absorption from the gastrointestinal tract is negligible. The marked reduction in the systemic availability of budesonide with the unshaken canisters confirms that the performance of a pressurized metered-dose inhaler is very much dependent on proper handling.

Administration, Topical↗
PubMed1998

Treatment of acute asthma: salbutamol via jet nebuliser vs spacer and metered dose inhaler.

OBJECTIVE: To compare the efficacy of salbutamol delivered by jet nebuliser (JN) with salbutamol via a pressurised metered dose inhaler (PMDI) and a large volume spacer (Volumatic) for management of acute asthma. STUDY POPULATION: A total of 160 children aged from 4 to 12 years presenting to an Emergency Department with acute asthma. METHODS: The study was of multicentre (n=5) randomised, double blind, parallel design. Children weighing less than 25 kg received salbutamol 2.5 mg via the JN or 600 microg (six puffs) from the PMDI. Children over 25 kg received salbutamol 5 mg via the JN or 1200 microg (12 puffs) via the PMDI. Clinical score (range 0-12) and PEF (over 7 years) were recorded at baseline and 15, 30, 45 and 60 mins post administration. RESULTS: The improvement from baseline at 30 min in the clinical score was 1.87 for JN and 1.43 for PMDI (P=0.09) and at 60 min was 2.15 for JN and 1.12 for PMDI (P=0.0001). The improvement in PEF at 30 min was 51 L min(-1) for JN and 27 L min(-1) for PMDI (P=0.0007) and at 60 min was 57 L min(-1) for JN and 31.5 L min(-1) for PMDI (P=0.001). CONCLUSION: Administration of salbutamol via a PMDI and a large volume spacer device provides effective relief in the management of acute asthma in children, but to a lesser extent than a jet nebuliser. This difference may represent a dose response effect.

Acute Disease↗
PubMed2000

Pharmacokinetics of flunisolide administered via metered dose inhaler with and without a spacer device and following oral administration.

BACKGROUND: After inhalation of a glucocorticoid from a meter dose inhaler (MDI), a certain portion of the delivered dose is deposited in the lungs, and the remainder is deposited in the oropharynx. OBJECTIVE: To examine the absolute bioavailability of flunisolide given orally via metered dose inhaler, and metered dose inhaler with a commercially available spacer device as well as to determine the fraction of drug deposited in the lungs following inhalation. METHODS: Twenty-four healthy volunteers were enrolled in the study; twenty-two completed the study. The IRB approved the study protocol, and informed consent was obtained. Volunteers received four treatments: treatment A (MDI), 1.0 mg inhaled flunisolide; treatment B (MDI-S), 1.0 mg inhaled flunisolide with a spacer device; treatment C, 1.0 mg of orally administered flunisolide with 240 mL of water; and treatment D, 1.0 mg intravenous flunisolide by IV push in the antecubital vein over 60 seconds. Plasma and urine flunisolide were quantified by HPLC/mass spectrometry/mass spectrometry. RESULTS: Flunisolide is a corticosteroid with low oral bioavailability (6.7%), which was found to be lower than previously reported. Similar AUCs were observed between the MDI and MDI-S groups, but by using mass balance equations, it appears that more flunisolide was delivered to the lungs in the MDI-S group (410 microg versus 280 microg). Oropharyngeal deposition was an important difference between the two inhaler groups. Approximately an 11-fold reduction in the oropharyngeal deposition of flunisolide through use of the spacer device was observed. CONCLUSIONS: Use of a spacer device improved pulmonary delivery of flunisolide by almost 50% and significantly decreased the oropharyngeal exposure to drug.

Administration, Oral↗
PubMed1998

The bronchoprotective efficacy of salbutamol inhaled from a new metered-dose powder inhaler compared with a conventional pressurized metered-dose inhaler connected to a spacer.

The aim of this study was to compare the efficacy of 100 micrograms of salbutamol inhaled from a new metered-dose powder inhaler (MDPI, Leiras Taifun, Finland) with that of a same dose of salbutamol inhaled from a conventional pressurized metered-dose inhaler with a large volume spacer (pMDI + S) in protecting against methacholine (Mch) induced bronchoconstriction. This was a 3 day, randomized, cross-over, partly blinded, placebo-controlled multicentre study where the pMDI + S was used as an open control. Twenty-six asthmatic outpatients with a baseline FEV1 > or = 60% of predicted and with bronchial hyperreactivity (PD20 FEV1 < or = 890 micrograms of Mch) were studied. On each study day the patients underwent an Mch provocation 30 min after inhaling placebo from the MDPI or a dose of 100 micrograms of salbutamol from the MDPI and from the pMDI + S. PD20 FEV1 and dose-response slope [DRS; maximal change in FEV1 (%)/dose of Mch (mumol)] were used to evaluate efficacy. The median values of PD20 FEV1 were 250, 622 and 1737 micrograms after placebo MDPI, salbutamol pMDI + S and salbutamol MDPI, respectively. The corresponding DRS values were -11.0%, -4.5% and -2.0% mumol-1. With both parameters, all differences were statistically significant (P < 0.05). In conclusion, 100 micrograms of salbutamol inhaled from Leiras Taifun MDPI offers better protection against Mch-induced bronchoconstriction than 100 micrograms of salbutamol from a pMDI connected to a large volume spacer device.

Adult↗
PubMed1998

Lung deposition of fenoterol and flunisolide delivered using a novel device for inhaled medicines: comparison of RESPIMAT with conventional metered-dose inhalers with and without spacer devices.

STUDY OBJECTIVES: To compare lung deposition of fenoterol or flunisolide administered from a novel, multidose inhalation device delivering liquid droplets (RESPIMAT; Boehringer Ingelheim Ltd; Bracknell, UK) or from conventional metered-dose inhalers (MDIs) with and without spacers. DESIGN: Two randomized, three-way crossover studies. SETTING: Clinical research laboratory. PARTICIPANTS: Healthy, nonsmoking volunteers. INTERVENTIONS: In one study, radiolabeled aerosols of fenoterol from the RESPIMAT device and from a conventional MDI with or without an Aerochamber spacer (Trudell Medical; London, Ontario Canada). In the second study, radiolabeled aerosols of flunisolide from a RESPIMAT device, from a RESPIMAT device modified by inclusion of a baffle/impactor in the mouthpiece, and from a conventional MDI with an Inhacort spacer (Boehringer Ingelheim; Ingelheim, Germany). MEASUREMENTS AND RESULTS: Assessment of the deposition of fenoterol or flunisolide in the lung and oropharynx using gamma scintigraphy. Safety was assessed based on reported adverse effects and spirometry (FEV1, FVC, and peak expiratory flow rate) to detect any paradoxical bronchoconstriction. The RESPIMAT device delivered significantly more fenoterol to the lungs than either an MDI alone or an MDI with Aerochamber (39.2% vs 11.0% and 9.9% of metered dose, respectively; p<0.01). Oropharyngeal deposition of fenoterol from the new device was lower than that from the MDI (37.1% vs 71.7%, respectively; p<0.01). The RESPIMAT device deposited significantly more flunisolide in the lungs compared with MDI plus spacer (44.6% vs 26.4%, respectively; p<0.01), while resulting in similar oropharyngeal deposition (26.2% vs 31.2%, respectively). Introduction of a baffle into the RESPIMAT system reduced lung deposition of flunisolide to 29.5%, and oropharyngeal deposition to 7.8% (p<0.01). CONCLUSION: The RESPIMAT device may prove to be an effective alternative to MDIs for the administration of inhaled bronchodilators and corticosteroids. The high lung deposition and low oropharyngeal deposition may lead to improved efficacy and tolerability of inhaled medications, especially corticosteroids.

Adult↗
PubMed2001

Aerosol delivery systems in childhood asthma.

Asthma in younger children appears to be increasing in prevalence, whilst at the same time it is recognized that inhaled corticosteroids and bronchodilators are the mainstay of treatment for this condition. Presently the devices available for aerosol treatment of young children are mostly developed for use in older children and adults. However, an awareness of the need for delivery systems dedicated to use by young children is increasing. The devices available at present for aerosol treatment of young children comprises the nebulizer, metered-dose inhaler with spacer, and dry powder inhaler. The inhaler strategy found most useful at present can be summarized as follows: children younger than 2 years can use MDI+spacer+mask or nebulization, while children above 2 years can use MDI+spacer (without mask). Older children (3-4 years) can be easily taught the use of a Rotahaler.

Aerosols↗
PubMed1991

Treatment of chronic bronchitis with terbutaline inhaled from a cone spacer with and without positive expiratory pressure.

Patients with chronic bronchitis were randomly allocated to 4 weeks treatment with terbutaline 0.5 mg inhaled through a cone spacer with an expiratory resistance creating a positive expiratory pressure (+PEP group) or without (-PEP group). The patients recorded their symptoms in a diary and peak expiratory flow (PEFR) was measured before and after each inhalation. PEFR increased significantly after inhaled terbutaline both with and without PEP. The mean increase in PEFR after terbutaline inhalations was significantly greater (p less than 0.0001) in the +PEP group (24 L/min) compared to the -PEP group (17 L/min). The +PEP group had less sputum and less difficulty with coughing up sputum compared to the -PEP group. This study showed a small but significant enhancement of the bronchodilation and a beneficial effect on symptoms when inhalation of beta-2-agonist was combined with PEP in patients with chronic bronchitis.

Bronchitis↗
PubMed1998

Automatic actuation of a dry powder inhaler into a nonelectrostatic spacer.

This article describes a new "automatic spacer" device, which has been developed to improve the delivery of inhaled medication to young children. In the device, a dry powder inhaler (DPI) is mechanically actuated into a nonelectrostatic spacer, producing an aerosol cloud of fine drug particles (aerodynamic diameter, < 4.7 microm) with a long half-life. The new device combines the principal advantages of the conventional spacer and the DPI. It has the potential to provide a high ratio between lung dose and pharyngeal dose, without need for coordination or forced inhalation, and it avoids exposure of the patient to the additives and propellants used in pressurized metered dose inhalers. Studies with the prototype device show a high yield of fine drug particles in the aerosol (mass median aerodynamic diameter, 2.8 microm), a high repeatability of drug delivery owing to the mechanical nature of the actuation (relative standard deviation, 12%), and a prolonged residence time of the fine particle aerosol (half-life of the fallout of the fine particles, 82 s). These features should prove advantageous in the treatment of young children with inhaled medication.

Budesonide↗
PubMed1992

Effect of inhaled terbutaline sulphate in relation to its deposition in the lungs.

We studied the effects of inhaled terbutaline on FEV1 and gas exchange, and the pattern of deposition within the lungs. To document this and to estimate the dose of terbutaline administered to the lungs, [99mTc]DTPA was added to nebulised terbutaline solution. The aerosol was deposited preferentially in large or small airways by using aerosols with different particle mass median diameters (1.5 and 4.8 microns) and different inhalation flow rates (0.25 and 1.0 l/s). The patients inhaled placebo and then three increasing doses of terbutaline (0.006, 0.02 and 0.08 mg to the lungs). Finally, 2 mg terbutaline was inhaled from a metered dose inhaler via a spacer. After each inhalation FEV1, PaO2 and PaCO2 was measured. The inhalation of small particles at a low flow resulted in a fairly uniform lung deposition, while larger particles at a higher flow resulted in heavy central deposition. Penetration index for small and large particles were 1.3 +/- 0.2 and 0.8 +/- 0.3 (P less than 0.001), respectively. In both groups FEV1 increased similarly with each dose, and at 0.02 and 0.08 mg the increase was significant (P less than 0.01). After eight metered doses of terbutaline sulphate (0.25 mg per dose) inhaled via a spacer, there was a further increase in FEV1 (P less than 0.001). Gas exchange did not differ between the two groups but if they were combined the DA-aO2 was significantly lower after metered doses than control (P less than 0.05). Thus, it appears that the site of deposition is not important for the bronchodilator effect of terbutaline, and gas exchange tended to improve with both modes of administration.

Adult↗
PubMed1995

[Comparison by twin impinger of the distribution patterns of two beclomethasone dipropionate metered dose inhalers and of two spacer devices].

A Twin Impinger was used to assess the influence of the number of puffs on the distribution patterns of two commercially available beclomethasone dipropionate (BDP) metered dose inhalers, and the effects of two kinds of spacer devices were also compared. No difference was observed in the distribution pattern up to the 10th puff between the two metered dose inhalers. Clinically, the amount of BDP inhaled into the lungs is said to depend on the number of puffs taken, but in this study, there was a significant difference in the distribution pattern between these 2 inhalers. In the stage assumed to represent the oropharynx site, the distribution ratio of BDP was greater after administration with an Aldecin than with a Becotide inhaler. In contrast, in the stage assumed to represent the lung, the distribution ratio of BDP was greater with the Becotide inhaler. This result suggests that the amount of BDP inhaled in the lungs may vary between these two preparations. The effects of spacer devices were also investigated in 4 puffs. These spacer devices caused the distribution ratio in the stage assumed to represent the oropharynx to decrease by at least 90%, irrespective of the type of metered dose inhaler. This result suggests that spacer devices are useful in reducing local side effects in the oropharynx. In the stage assumed to represent the lung, the distribution ratio achieved with the Becotide inhaler with Volumatic was greater than that with the Aldecin with InspirEase. This study suggests that the best therapeutic effects can be expected from a combination of Becotide inhaler and Volumatic.

Beclomethasone↗
PubMed1997

Beclomethasone dipropionate 250 µg per dose metered dose inhalers: effect of Volumatic spacer on potentially respirable dose.

The aerodynamic particle size distribution of beclomethasone dipropionate from 250 µg per dose metered dose inhalers tested in conjunction with a Volumatic spacer, was studied using a multistage liquid impinger. The products tested were Becloforte (Allen and Hanburys), Becloforte (parallel import from Spain), Beclazone 250 (Norton Healthcare) and Filair Forte (3M Health Care). Tests were performed with either zero or 3 s time delay between actuation of the inhaler and sampling. Filair Forte gave significantly lower deposition than all the other products in both the <6.8 and <3.1 µm size ranges with both zero and 3 s residence times (49.8% less than Becloforte, UK-origin, at <6.8 µm, zero residence time). This was despite fitting well in the Volumatic. Testing a second batch of Filair Forte confirmed the low deposition results. The only other significant differences were greater depositions from Becloforte (Spanish) compared to Beclazone 250 (<6.8 µm, zero residence time and <3.1 µm, 3 s residence time) and between Becloforte (Spanish) and all the other products (<3.1 µm, zero residence time). The magnitude of these differences were, however, less marked than those shown by Filair Forte. Increasing the residence time of the aerosol in the Volumatic to 3 s, simulating how patients may use the inhaler/spacer combination, gave similar results to those obtained with zero residence time. Filair Forte, used with the Volumatic, delivered a relatively low dose in the potentially respirable size range, compared to Becloforte. No substantial differences were seen at <6.8 µm between Becloforte (UK or Spanish) or Beclazone 250. Further work would be required to determine the importance of the differences observed between the products in the <3.1 µm range.

Journal Article↗
PubMed1997

In vitro comparison of the amount of salbutamol available for inhalation from different formulations used with different spacer devices.

Metered-dose inhalers (MDIs) are currently being reformulated to contain hydrofluoroalkanes (HFAs), which do not damage the Earth's ozone layer. As different formulations of inhaled drugs may behave differently when used with spacer devices, we wished to determine the amount of salbutamol available for inhalation from a conventional metered-dose inhaler (Ventolin) and a new HFA-containing formulation (Airomir), when used with two different spacers. A glass multistage liquid impinger was used to determine the amount of salbutamol delivered from the inhalers used with the Aerochamber and the Nebuhaler spacer devices. High speed video-recordings of inhaler actuation into air were made, and the speed of the aerosol and the aerosol cloud volume were measured. More salbutamol in small particles (<5 microm) was delivered from the Airomir MDI than the Ventolin MDI, when used with the Aerochamber (40.4 (95% confidence interval (95% CI) 31.2-49.6) versus 19.5 (19.0-20.0) microg) and the Nebuhaler (42.1 (36.3-47.9) versus 24.6 (23.3-25.8) microg). The aerosol cloud from the Airomir MDI was slower than the Ventolin aerosol, and 60 ms after actuation had travelled 186 mm, whereas the Ventolin aerosol had travelled 320 mm. At the same time, the Airomir aerosol occupied a smaller volume than the Ventolin MDI (251 (213-288) versus 695 (608-782) cm3). The hydrofluoroalkane formulation delivers more salbutamol than the conventional formulation when used either with the Aerochamber or Nebuhaler spacer. This may be because less drug is deposited in the spacer from the hydrofluoroalkane formulation, which is emitted from the metered-dose inhaler at a slower speed and occupies a smaller volume than the conventional formulation. The observed difference in drug delivery may be important for patients changing formulations, and in severe asthma, where high doses of salbutamol may be administered through a spacer.

Administration, Inhalation↗
PubMed2001

Comparative in vivo lung delivery of hydrofluoroalkane-salbutamol formulation via metered-dose inhaler alone, with plastic spacer, or with cardboard tube.

STUDY OBJECTIVE: To compare the lung delivery of chlorofluorocarbon-free salbutamol via a pressurized metered-dose inhaler (pMDI) alone, a pMDI with a small-volume plastic spacer, and a pMDI with a cardboard tube. DESIGN: A randomized, single (investigator)-blind, three-way, crossover study. SETTING: The Asthma and Allergy Research Group, Ninewells Hospital, University of Dundee, Dundee, Scotland, UK. PARTICIPANTS: Twelve healthy volunteers aged 16 to 65 years. INTERVENTIONS: The subjects were administered 400 microg of salbutamol via a pMDI alone, via a pMDI plus a small-volume plastic spacer, or via a pMDI plus a cardboard tube. MEASUREMENTS AND RESULTS: Blood samples for plasma salbutamol concentrations were taken at 5 min, 10 min, and 20 min after inhalation, to measure lung bioavailability as a surrogate for relative lung dose. The addition of the plastic spacer resulted in a significantly higher maximal plasma salbutamol concentration (CMAX) and average plasma salbutamol concentration (CAV) than the pMDI used alone. This amounted to a 1.48-fold (32%) difference (95% confidence interval [CI], 1.03 to 2.13) for CMAX and a 1.42-fold (30%) difference (95% CI, 1.01 to 2.00) for CAV. There was no significant difference in the CMAX or CAV comparing the addition of the cardboard tube with the plastic spacer or the pMDI alone. CONCLUSIONS: Using a chlorofluorocarbon-free pMDI with a plastic spacer produced statistically, but not biologically, significant greater lung delivery of salbutamol. If a spacer is required for reasons other than increasing delivered drug dose, then the addition of a readily available cardboard tube will fulfill many of the required functions with no expense to the patient.

Administration, Inhalation↗
PubMed2001

The role of domiciliary nebulizers in managing patients with severe COPD.

The difficulty of assessing nebulizer responses in chronic obstructive pulmonary disease (COPD) has been demonstrated before. This study aims to re-examine both the role of domiciliary nebulizers in COPD and also bronchodilator (BD) assessment in individuals. In a double-blind, randomized, cross-over trial, 19 stable patients with severe COPD were given the following medication 6-hourly for 2-week periods: (1) nebulized salbutamol 2.5 mg with ipratropium 0.5 mg and placebo inhalers (MDI) with spacer; (2) placebo nebules and inhaled salbutamol 400 microg with ipratropium 80 microg via MDI with spacer; (3) inhaled salbutamol 400 microg with ipratropium 80 microg via MDI with spacer (but no placebo nebulized drugs). Both nebulized and MDI drugs produced highly significant improvements in forced expiratory volume in 1 sec (FEV1), forced vital capacity (FVC), specific airways conductance, 6-min walking distance (6MWD) and residual volume. There were no significant differences between BD responses obtained after active nebulized and active MDI BDs. From the diary cards, 2 weeks of active nebulized BDs produced a slightly higher median peak expiratory flow (PEF) than active MDI BDs (236 and 219 l m(-1), respectively, P=0.01) and slightly less extra inhaler use (0.8 and 1.1 puffs, respectively, P<0.05) but no significant difference in dyspnoea or quality of life (QOL) scores. There were significant correlations between domiciliary PEF and acute BD-induced changes in FVC and 6MWD, and also between domiciliary dyspnoea scores and acute changes in both total lung capacity and 6MWD. In conclusion, nebulized medication conferred little clinical advantage over the regular use of inhalers with spacers in this group of patients with severe COPD. However, acute changes in total lung capacity, FVC and 6MWD may be useful predictors of the longer-term effects of nebulized BDs in individual patients.

Administration, Inhalation↗
PubMed2000

High-percentage lung delivery in children from detergent-treated spacers.

Pressurized metered-dose inhalers attached to spacers are now the most common form of delivery of anti-asthma medication in children. However, no reliable data are available of how much drug reaches the lungs in children of different ages. This information is crucial, as it determines the efficacy of therapy. In this study, we present information on the amount of drug reaching the lungs in children from a pressurized metered-dose inhaler attached to a detergent-coated spacer. We studied 18 asthmatic children inhaling radiolabeled salbutamol through detergent treated spacers to minimize electrostatic charge on the spacer wall. Lung deposition was much higher than expected when using detergent-coated spacers. Mean (SD) lung deposition, expressed as a percentage of the total actuated dose (five actuations), was 16.4% (5.5) in younger children inhaling through a small volume spacer, and 28.2% (6.7) and 41.8% (3. 8) in older children inhaling with different breathing patterns through a large volume spacer. These findings have major implications for dosage regimens for inhaled anti-asthma medication in children. Lower doses may be sufficient for adequate drugs delivered through spacers treated for static to achieve a desired clinical response.

Administration, Inhalation↗
PubMed2006

A new small volume holding chamber for asthmatic children: comparison with Babyhaler spacer.

When a new holding chamber for administrating inhaled medication is to be marketed, it needs to be compared with existing chambers with two questions in mind: is this chamber well accepted by patients and is there an in vitro equivalence? We compared the new small volume non-electrostatic valved holding chamber, usable with all pressurized metered-dose inhalers and equipped with a funny facemask, Vortex (Pari GmbH, Germany), to the most frequently prescribed holding chamber in France, Babyhaler (GlaxoSmithKline Laboratories). Preferences were studied for 75 families with a child no more than 4 yr old, using standard questionnaires. An in vitro study assessed the delivered dose and the particle size distribution of two HFA beclomethasone dipropionate pressurized metered dose inhalers (Becotide 250 microg per dose and Nexxair 100 microg per dose) by dose uniformity sample apparatus and cascade impactor according to the European Pharmacopoeia. Vortex was preferred by 95% of the families because of its small size, its duck facemask, and its robust appearance. Among children able to give their opinion, 86% preferred Vortex to Babyhaler. In vitro, both holding chambers reduced the delivered dose of beclomethasone dipropionate and increased the quantity of particles smaller than 5 microm in diameter with both medications. A higher proportion of fine particles was obtained with Nexxair than with Becotide (p < 0.05) and with Vortex than with Babyhaler (p < 0.05). As expected, throat deposition is dramatically reduced for both drugs with both holding chambers. The in vitro difference in the particle size distribution of beclomethasone dipropionate with both holding chambers probably has no clinical influence.

Administration, Inhalation↗