Large Volume Spacer Research Articles

Adrenal suppression in asthmatic children receiving low-dose inhaled budesonide: comparison between dry powder inhaler and pressurized metered-dose inhaler attached to a spacer

Dry powder inhalers (DPI) have in recent years become a common mode for administration of inhaled corticosteroids for preventive therapy of asthma. Inhaled steroids delivered by DPI achieve increased lung deposition compared with pressurized metered-dose inhalers (pMDI), which is associated with increased therapeutic effect. This may be associated with increased systemic absorption. The purpose of this study was to evaluate the prevalence of adrenal suppression in children using low-dose budesonide given by DPI, as compared with pMDI attached to a large-volume spacer device (pMDI + spacer). In an open-labeled crossover study, 15 asthmatic children aged 5 to 15 years received 200 microg of inhaled budesonide twice daily by DPI (Turbuhaler, Astra, Draco AB, Lund, Sweden) and by pMDI + spacer, 1 month each, in a randomized order. Twenty-four-hour urine collections were performed at baseline and at the end of each of the 2 months of the study period, and urinary cortisol and creatinine were measured. Baseline urinary cortisol:creatinine was 0.038 +/- 0.012 microg/mg, similar in both groups. After 1 month of DPI therapy, urinary cortisol:creatinine was reduced by 27 +/- 16% to 0.028 +/- 0.012 microg/mg (P = 0.018). Urinary cortisol:creatinine after 1 month of pMDI + spacer therapy was similar to baseline 0.037 +/- 0.019 microg/mg (P = 0.78). Treatment of asthmatic children with budesonide 400 microg daily given via a DPI for 1 month was associated with hypothalamic-pituitary-adrenal axis suppression. This effect was not observed with the same dose of budesonide administered via pMDI + spacer. This indicates that systemic absorption might be reduced with pMDI + spacer therapy.

Drug delivery.

What we know: In preschool children, small-volume spacers perform better than large-volume spacers. Detergent is the best antistatic agent for spacers, increasing lung delivery two- to threefold, but it must not be rinsed off. A mouthpiece should be used in children aged 2-3 years or older, as lung delivery is two- to threefold higher for oral inhalation than nasal inhalation (ie, by mask). Inhaled drug doses do not generally need to be reduced in infants and young children owing to inefficiencies of delivery in younger patients. Nebulisers are "dinosaurs" and not needed for most children with asthma. What we need to know: What is the best inhalation technique for spacers? How long should children breathe, how many breaths should they take, and at what age should they breath-hold? How should children, parents and doctors be instructed to achieve optimal levels of electrostatic charge reduction for spacers? How much should inhaled steroid dose be reduced when a spacer is used optimally? What dosing instructions should be given for beta(2)-agonists delivered by spacer?

Pressurised metered-dose inhalers versus all other hand-held inhalers devices to deliver bronchodilators for chronic obstructive pulmonary disease.

Bronchodilator therapy for COPD may be delivered by a number of different inhaler devices. To determine the efficacy of pressurised metered dose inhalers (pMDI) compared to any other handheld inhaler device for the delivery of bronchodilators in non-acute COPD. The Cochrane Collaboration, Asthma and Wheeze Randomised Controlled Clinical Trials register was searched for studies. The UK pharmaceutical companies who manufacture inhaled COPD medication were also contacted. Two reviewers independently reviewed the results of computerised search and any potentially relevant articles were obtained in full. One reviewer extracted details of each trial and a second reviewer checked all extracted data. Dichotomous outcomes such as exacerbation rate were assessed using relative risk, with 95% confidence interval (CI). Fourteen studies appeared potentially relevant but only three studies (61 patients) met the entry criteria. Two studies compared a dry powder device (Turbuhaler or Rotahaler) with a pMDI for beta2-agonist delivery, and one (36 patients cross-over design) the Respimat (soft mist device for ipratropium) vs a pMDI. For the Turbuhaler and Rotahaler, none of the reported outcome measures were significantly different. The Rotahaler study used a high and low dose of medication with or without large volume spacer. The study using the Respimat showed significant increases in FEV1 when compared to a pMDI (difference in change from base line 70 ml, 95% CI 10, 130 ml). The effect on change in FVC was of similar size. There were no differences between these two devices for any other reported outcomes. Although none of the included studies required prior patient ability to use any of the inhalers (and no study mentioned device training), it was assumed that all patients randomised into the study would have undergone training in use of the study inhalers and were capable of using those devices. In patients with stable COPD, pMDI produced similar outcomes to a dry powder device for delivering beta2-agonists, but the very small number of studies and included patients does not permit firm conclusions to be drawn. The soft mist device for ipratropium was more effective than a pMDI, but the data come from one small study. There need to be further well designed randomised controlled trials to define the role of inhaler devices using bronchodilators in stable COPD.

Antiasthmatic drug delivery in children.

Asthma therapy can be administered to children via a number of routes, including oral, inhaled (via a multiplicity of devices), rectal, intravenous, subcutaneous, and intramuscular. The inhaled route is used most often. This can reduce, but never eliminate, systemic absorption. Swallowed aerosolized medication is subject to hepatic first-pass metabolism, but this metabolic route is bypassed by the drug impacting on the airway, including the pharynx. Although there are a large number of studies from a laboratory setting about drug deposition characteristics, there is very little evidence from community-based studies about what families think actually works well in the everyday treatment of the child. However, it is clear that altering the inhaler device can result in marked changes in the dose administered, and any such change should be part of a review of the dose of prescribed medication. Nebulizers are being used much less frequently, and in particular, all but the most severe exacerbations can be treated at least as effectively with equivalent dosages of beta(2)-adrenoceptor agonists from a large volume spacer.

A comparison of the lung deposition of budesonide from Easyhaler®, Turbuhaler®and pMDI plus spacer in asthmatic patients

Inhaled corticosteroids in pressurized metered does inhalers (pMDIs) are often delivered via a large volume spacer device, but these are bulky and inconvenient. Dry powder inhalers (DPIs) provide a highly portable and convenient propellant-free alternative to pMDIs for asthma maintenance therapy. However, each DPI could have unique in vivo delivery characteristics. In order to quantify the total and regional lung deposition of budesonide (200 μ g) from (a) Easyhaler®, (b) Turbuhaler®and (c) pMDI plus Nebuhaler®750 ml spacer, a three-way randomized cross-over study was carried out in 12 mild to moderate asthmatic patients. Deposition was quantified by the imaging technique of gamma scintigraphy. Optimal inhalation techniques were used throughout. Mean (SD) whole lung deposition (% metered dose) was similar for Easyhaler®[18·5 (7·8) %] and Turbuhaler®[21·8 (8·2) %], but was significantly higher for pMDI plus Nebuhaler®[44·1 (10·0) %, P<0·01]. The regional distribution patterns in the lungs were predominantly central for all three devices. Nebuhaler®reduced oropharyngeal deposition significantly compared with the two DPIs. Easyhaler®Showed comparable deposition to Turbuhaler®and hence drugs delivered by Easyhaler®would be expected to have a similar clinical effect to those delivered by Turbuhaler®in asthma maintenance therapy.

Safety of inhaled corticosteroid therapy in young children with asthma

Physicians have had some reluctance to use inhaled corticosteroids in very young children with asthma because of the possible risks of adverse systemic effects. The purpose of this study was to evaluate the effects of fluticasone propionate on growth and adrenocortical function in young children with asthma. We performed an open, prospective study for 24 weeks of 20 children with asthma, 2.5 to 5.0 years of age, who had received fluticasone by a large volume spacer at dosages ranging from 190.50 to 565.40 microg/m2 daily. Growth was evaluated by height standard deviation scores measured by a stadiometer. Adrenocortical function was evaluated twice in each child, before and after the study, by determining fasting serum cortisol concentrations at 8 AM and also at 30 and 60 minutes after adrenocorticotropic hormone stimulation. Posttreatment values of height standard deviation scores and fasting morning serum cortisol concentrations were compared with those of 18 age-matched children, who constituted the control group. The evaluation of mean +/- SEM (and range) of height standard deviation scores revealed a significant decrease from 0.44 +/- 0.27 (-1.46 to 2.22) to 0.28 +/- 0.26 (-1.51 to 2.07; P = 0.01) at week 18 and to 0.25 +/- 0.24 (-1.90 to 2.13; P = 0.04) at the week 24 in fluticasone-treated children. At the end of the treatment, however, height standard deviation scores of these children did not differ significantly (P = 0.35) from those of the control group. Delayed growth with medium-duration treatment was not associated with alterations in serum cortisol measurements, either at baseline or after stimulation. The mean fasting morning serum cortisol concentrations did not differ significantly between the fluticasone-treated patients and the control group. Some concern prevails about the safety of medium- or long-term treatment with regularly inhaled corticosteroids in young children with asthma. The prepubertal growth may be delayed, but the effect on ultimate height remains uncertain in such children. Growth should be regularly monitored in children who begin inhaled corticosteroid therapy for mild persistent asthma at an age <5 years old.

Montelukast and Churg-Strauss syndrome

I read with interest the case report by Tuggey and Hosker where Churg-Strauss syndrome was associated with the use of montelukast in an asthmatic patient in whom there was no recent exposure to oral corticosteroid.1 However, it is worth noting that the patient was using a high dose of inhaled fluticasone propionate (1.5 mg/day) via a large volume spacer prior to the introduction of montelukast. In this respect, a large volume spacer has been shown to double the systemic bioavailability of fluticasone propionate compared with a metered dose inhaler, in terms of its propensity for adrenal suppression.2 In a dose ranging study in asthmatic patients a comparison was made between inhaled fluticasone propionate via a 750 ml large volume spacer (Volumatic) and oral prednisolone.3 Regression analysis showed significant (p<0.05) dose-response relationships with both drugs for suppression of peripheral blood eosinophils (fig 1), in keeping with their systemic bioavailability. At the highest doses studied for prednisolone (20 mg/day) and fluticasone propionate (2 mg/day nominal dose) there was a 1.5-fold (95% CI 0.8 to 2.7) greater suppression of blood eosinophils with prednisolone than with fluticasone although, as indicated by the confidence interval (which included unity), this did not represent a significant …

Relative Lung Bioavailability of Generic Sodium Cromoglycate Inhalers Used With and Without A Spacer Device

The relative lung bioavailability of sodium cromoglycate following inhalation has been evaluated using urinary drug excretion in nine healthly volunteers. Each inhaled four 5 mg sodium cromoglycate doses from a generic metered dose inhaler (MDI) and when it was attached to large volume spacer (MDI + VOL). A breath-actuated MDI was also evaluated either used on its own (EB) or attached to a small volume spacer tube (EBO). The mean (SD) urinary excretion of sodium cromoglycate in the first 30 min post-inhalation was 34.1 (20.2), 211.7 (123.5), 29.3 (19.5) and 52.8 (36.0) μg following MDI, MDI+VOL, EB and EBO, respectively. The cumulative mean (SD) urinary excretion of sodium cromoglycate over the 24 h post-inhalation was 364.7 (266.2), 1227.1 (459.0), 280.2 (155.4) and 429.5 (176.7) μg. A metered dose inhaler attached to a large volume spacer delivers more sodium cromoglycate to the lungs than any other inhalation method.

Treatment of Acute Asthma in a Field Environment Using Albuterol and a Large Volume Spacer

Treatment of Acute Asthma in a Field Environment Using Albuterol and a Large Volume Spacer

Emitted doses of salbutamol pressurized metered-dose inhaler from five different plastic spacer devices

In a recent clinical study we have demonstrated that the bronchodilator effect of 200 microg salbutamol (Ventoline) was spacer device-dependent in 100 tested asthmatic children, with the Babyhaler providing greater efficacy for improving peak expiratory flow rate compared to Aeroscopic, Nebuhaler, Aerochamber and Volumatic. The aim of this present study was to correlate our clinical results to in vitro determinations of the emitted dose (ED) of Ventoline administered via these five different plastic spacer devices. ED was determined from the mean of single doses collected in unit dose sampling tubes using a constant suction flow of 28.3 L/min. Three pressurized metered-dose inhalers and three sets of spacer devices were used to obtain a total of 30 measurements per group. Inter-group results were compared by RM-ANOVA or Student-Newman-Keuls method when indicated. Babyhaler delivered significantly (P < 0.05) more salbutamol than Nebuhaler, Aerochamber and Aeroscopic (mean +/- standard deviation: 63.6 +/- 2.9 microg/100 microg actuation for Babyhaler vs. 59.4 +/- 8.6 for Nebuhaler, 50.8 +/- 5.0 for Aerochamber and 47.5 + 2.5 for Aeroscopic). The ED from Volumatic (61.5 +/- 7.9 microg/100 microg actuation) was similar to that from the Babyhaler. The variability in the ED was greatest with the large volume spacers. Despite a greater ED from the Babyhaler, in vitro results do not fully explain the in vivo results. However, the previously described clinical improvement seen with the Babyhaler may be due to the quantitatively different aerosol production in a more 'useful' size range, as well as the different breathing patterns of the children tested. The results of this present study question the relevance of mouthpiece filter collection studies using a constant sampling in predicting clinical or physiological outcomes.

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.

Equivalence of Two Steroid-Containing Inhalers: Easyhaler Multidose Powder Inhaler Compared with Conventional Aerosol with Large-Volume Spacer

Background and Objectives: An equivalence study was conducted in which the efficacy and safety of a daily dose of 800 μg of beclomethasone diproprionate administered via a multidose powder inhaler, Easyhaler, and via a metered-dose inhaler (MDI) with a large-volume spacer were compared in adult, newly diagnosed, steroid-naive asthmatic patients. Acceptability of the medications was also compared. Methods: One hundred and forty-four patients were recruited into the double-blind, double-dummy, randomised, parallel-group multicentre study. The study treatment period was 8 weeks. It was preceded by a 2-week run-in period. Morning and evening peak expiratory flow (PEF), numbers of inhalations of a sympathomimetic and asthma symptoms were recorded daily. Spirometry and histamine challenge were performed, and health-related quality of life and morning serum cortisol levels measured during control visits. Results: Criteria indicating treatment equivalence were met. The mean of the primary outcome variable, morning PEF, increased significantly, from 426 to 461 litres/min in the Easyhaler group and from 436 to 467 litres/min in the MDI+spacer group. Similar improvements between groups were also seen in relation to all secondary variables. Changes in serum cortisol levels were minor. In 6 out of 10 questions about device acceptability, the majority of patients rated Easyhaler as better than the MDI+spacer combination. Conclusion: It was concluded that the devices tested were equivalent in terms of efficacy and safety.

The effect of spacers on the delivery of metered dose aerosols of nedocromil sodium and disodium cromoglycate

The effect of the spacers (Fisonair®, Breath-A-Tech®, Volumatic® and Nebuhaler®) on the in vitro aerosol characteristics of two propellant-driven metered dose inhalers (MDIs), Tilade® (nedocromil sodium) and Intal® (disodium cromoglycate), was studied. The measurement was carried out on a Marple–Miller impactor operating at 30 l/min. Five actuations were collected for the drug assay. The results showed that Tilade® (label claim 2 mg active per actuation) and Intal® (label claim 5 mg active per actuation) generated aerosols with a fine particle mass (FPM, i.e. mass of particles 5 μm in the aerosol) of 0.34 mg (S.D. 0.01, n=4) and 0.02 mg (S.D. 0.01, n=4) per actuation, respectively. For both inhalers, large volume spacers increased (Fisonair®>Nebuhaler®>Volumatic®) while small volume spacer (Breath-A-Tech®) decreased the FPM. The FPM (per actuation) for Tilade® with Fisonair®, Nebuhaler®, Volumatic® and Breath-A-Tech® was 0.52 (0.03), 0.45 (0.03), 0.41 (0.04) and 0.09 (0.04) mg, respectively, while for Intal® the corresponding values were 0.41 (0.02), 0.32 (0.04), 0.28 (0.03) and 0.08 (0.01) mg. Thus, the fine particle mass can be either increased or decreased, depending on the spacer selected. In addition, all spacers significantly reduced the coarse particle (≥10 μm) mass, with Fisonair®, Breath-A-Tech®, Nebuhaler® and Volumatic® producing only 7.6, 0.4, 5.2 and 2.6%, respectively of that from Tilade® alone and 15.6, 0.7, 5.4 and 4.1%, respectively of that from Intal® alone. The general trends for Tilade® and Intal® were similar but not quantitatively identical. The proper choice of spacers is therefore important for the optimal delivery of Tilade® and Intal®.

Evaluation of the Effect of a Large Volume Spacer on the Systemic Bioactivity of Fluticasone Propionate Metered-Dose Inhaler

Inhaled corticosteroids such as fluticasone propionate (FP) have dose-related systemic effects, including adrenal suppression. We have therefore investigated the effect of adding a large volume spacer on the systemic bioactivity of FP given via a pressurized metered-dose inhaler (pMDI). Fourteen healthy volunteers (mean age, 29.9 years old) were studied using an open, randomized, placebo-controlled, three-way crossover design. Single doses of the following were given at 5:00 PM in a randomized sequence: (1) eight puffs of FP by pMDI, 1.76 mg (250 microg ex-valve, 220 microg ex-actuator); (2) eight puffs of FP by pMDI, 250 microg, with 750-mL spacer (Volumatic; Allen & Hanburys; Uxbridge, UK); and (3) eight puffs of placebo by pMDI. Measurements were made after each dose, including overnight and early morning urinary cortisol/creatinine ratios and 8:00 AM serum cortisol. Significant (p < 0.05) suppression of all three end points occurred with each active treatment compared to treatment with placebo. Furthermore, significant (p < 0.05) additional suppression occurred when comparing FP by pMDI alone to FP by pMDI with spacer. Geometric mean fold differences (95% confidence interval for fold difference) between FP by pMDI alone and FP by pMDI with spacer were 1.94-fold (1.00-3.78) for overnight urinary cortisol/creatinine ratio and 1.98-fold (1.26-3.10) for 8:00 AM serum cortisol. This was mirrored by a twofold rise in the number of values for uncorrected overnight urinary cortisol < 10 nmol/10 h: placebo treatment (none of 14 subjects); FP by pMDI (6 of 14 subjects; 43%); and FP by pMDI with spacer (12 of 14 subjects; 86%). The use of a large volume spacer with FP by pMDI results in a twofold increase in the systemic bioavailability as assessed by sensitive measures of adrenal suppression. This, in turn, reflects a twofold improvement in respirable dose delivery with the spacer device.

MDI With Spacer vs Nebulizer for Hospital Treatment of Asthma

Critical Care| September 01 1999 MDI With Spacer vs Nebulizer for Hospital Treatment of Asthma AAP Grand Rounds (1999) 2 (3): 27. https://doi.org/10.1542/gr.2-3-27 Views Icon Views Article contents Figures & tables Video Audio Supplementary Data Peer Review Share Icon Share Twitter LinkedIn Tools Icon Tools Get Permissions Cite Icon Cite Search Site Citation MDI With Spacer vs Nebulizer for Hospital Treatment of Asthma. AAP Grand Rounds September 1999; 2 (3): 27. https://doi.org/10.1542/gr.2-3-27 Download citation file: Ris (Zotero) Reference Manager EasyBib Bookends Mendeley Papers EndNote RefWorks BibTex toolbar search nav search search input Search input auto suggest search filter All PublicationsAll JournalsAAP Grand RoundsPediatricsHospital PediatricsPediatrics In ReviewNeoReviewsAAP NewsAll AAP Sites Search Advanced Search Topics: asthma, spacer device Source: Dewar AL, Stewart A, Cogswell JJ, Connett GJ. A randomised controlled trial to assess the relative benefits of large volume spacers and nebulisers to treat acute asthma in hospital. Arch Dis Child. 1999;80(5):421–423. Children from the United Kingdom admitted to the hospital during a 5-month study period with acute asthma were enrolled in a randomized, controlled study. Patients were excluded if they were less than 3 years, needed intravenous beta agonist therapy, couldn’t use a spacer mouthpiece effectively or were readmitted during the 5-month study period. Thirty-three control children (mean age, 8 years) received nebulized salbutamol (5 mg up to hourly by jet nebulizer driven by oxygen at 6–8 L/min) while 29 children (mean age, 6.9 years) received salbutamol from a metered dose inhaler (MDI) with a large volume spacer. The puffs were 100 mcg and the child could receive up to 10 puffs... You do not currently have access to this content.

Systemic Bioavailability and Potency of High-Dose Inhaled Corticosteroids: A Comparison of Four Inhaler Devices and Three Drugs in Healthy Adult Volunteers

To compare the systemic bioavailability (assessed by cortisol suppression) of high-dose budesonide when given by four inhaler devices and orally. Also studied are the relative systemic potencies of three inhaled steroids (budesonide, fluticasone propionate, and beclomethasone dipropionate) when given by metered-dose inhaler (MDI) with a large volume spacer. Double-blind, crossover, placebo-controlled trial. Sixteen healthy, steroid-naive adult volunteers. On separate occasions, each subjects took 4 mg of budesonide through the following devices: MDI alone, MDI with 750-mL. spacer, dry-powder inhaler and nebulizer; 4 mg of budesonide was also taken orally to assess the effects of GI absorption. For the drug comparison, each subject took 4 mg of budesonide, fluticasone, and beclomethasone, and 2 mg of budesonide and fluticasone by MDI and spacer. Greatest percent suppression (95% confidence interval) of 9:00 AM cortisol with budesonide was observed with MDI alone (73% [57 to 90]) and turbohaler (72% [58 to 86]) compared with MDI spacer (42% [22 to 64]) and oral administration (14% [+6- to -34]). Nebulized budesonide produced an insignificant rise in 9:00 AM cortisol level. The most suppressive drug (given by MDI spacer) was fluticasone at 4 mg (86% [82 to 91]) and at 2 mg (72% [59 to 85]). The least suppressive drug was budesonide at 4 mg (43% [22 to 64]) and at 2 mg (25% [3 to 47]). The effects of 4 mg of beclomethasone were intermediate (66% [49 to 82%]). The choice of delivery device for administration of budesonide can lead to important differences in systemic bioavailability. Fluticasone has greater systemic potency than budesonide or beclomethasone when given at microgram equivalent dosage. The systemic potency ratio of fluticasone propionate to budesonide in normal human volunteers in the present study is similar to the therapeutic potency ratio of the drug in asthmatic patients (approximately 2:1).

Comparison of the Bronchodilator Effects of Salbutamol Delivered via a Metered-Dose Inhaler with Spacer, a Dry-Powder Inhaler, and a Jet Nebulizer in Patients with Chronic Obstructive Pulmonary Disease

The aim of this study was to compare the bronchodilator effects of salbutamol delivered via three different devices: a dry-powder inhaler (DPI), a metered-dose inhaler (MDI) with a large-volume spacer and a jet nebulizer (NEB) in patients with stable chronic obstructive pulmonary disease (COPD). Ten male patients with stable COPD [age: 67.2 ± 3.8 years, forced expiratory volume in 1 s (FEV₁): 1.56 ± 0.32 liters] were studied in a randomized, double-blind and crossover manner. Each patient received 200 or 1,000 µg salbutamol via an MDI with an InspirEase^TM spacer, a Rotahaler^TM, or a DeVilbiss 646^TM nebulizer (NEB), or matching placebo on 7 separate days. Spirometry was performed before and 15, 30, 60, 90, 120, and 240 min after inhalation. With the 200-µg dose, only DPI produced a small but greater response in maximum FEV₁ and in area under the time-response curve (AUC-FEV₁) compared with placebo. With the 1,000-µg dose, DPI and MDI produced equally greater improvements in both maximum FEV₁ and AUC–FEV₁ than NEB. An equal bronchodilating effect can be obtained using either DPI or MDI with a spacer device, whereas the NEB was less effective when the same dose was administered.

One year prospective open study of the effect of high dose inhaled steroids, fluticasone propionate, and budesonide on bone markers and bone mineral density

BACKGROUNDInhaled corticosteroids are recognised as the most effective agents in the treatment of asthma. However, concerns have been expressed about the effects of high doses of inhaled corticosteroids on safety...

Systemic activity of inhaled and swallowed beclomethasone dipropionate and the effect of different inhaler devices.

Inhaled glucocorticoids such as beclomethasone dipropionate, which are used in the treatment of asthma, may be associated with systemic adverse effects. To determine whether any systemic absorption following the inhalation...

A New Beclomethasone Dipropionate Multidose Powder Inhaler in the Treatment of Bronchial Asthma

The clinical efficacy, tolerability and acceptability of a new multidose powder inhaler (MDPI) containing beclomethasone dipropionate (BDP) were compared with those of a BDP aerosol administered with a large volume spacer (MDI-spacer) among adult asthmatics currently receiving from 500 to 1,000 µg/day of an inhaled corticosteroid. During the study, the dosage of BDP from both devices was 400 µg twice daily. Ninety-one patients were randomized to the MDPI group and 42 to the MDI-spacer group. The trial was performed as an open, randomized, parallel group multicenter study. The duration of the treatment period was 12 weeks, and the study was preceded by a 2-week run-in period. During the run-in period, the mean morning peak expiratory flow (PEF) was 487 and 466 1/min in the MDPI and MDI-spacer groups, respectively. After the 12-week treatment, the morning PEF was 491 l/min in the MDPI group and 463 l/min in the MDI-spacer group. The evening values were 500 and 479 l/min during the run-in period and 496 and 476 l/min after the 12-week treatment, respectively. Asthma symptom scores and the use of rescue medication were low in both groups, indicating good efficacy of the preparations tested. The median dose of histamine required to decrease forced expiratory volume in 1 s by 15% increased during the study from 800 to 1,098 µg in the MDPI group and from 795 to 960 µg in the MDI-spacer group. The most frequent adverse events in both groups were hoarseness and sore throat. There were no statistically significant differences between the treatment groups in serum cortisol values or in the number of patients with thrush. Seventy-two percent of the patients regarded the MDPI easier to use while 95% considered it more portable. Over 80% of the patients felt that the MDPI was also easier to clean and as easy or easier to learn to use than the MDI-spacer. To conclude, the novel powder inhaler is well tolerated and at least equally effective as the conventional MDI-spacer combination in the treatment of asthma with BDP. However, in everyday use, patients clearly favored the powder inhaler.