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PubMed2000

Role of leukotriene receptor antagonists in pediatric asthma.

During the past decade, the inflammatory mechanisms that result in the clinical syndrome we call asthma have been emphasized in research, publications, and the various asthma management guidelines. This information clearly emphasizes the treatment of asthma with maintenance controller therapies early after the onset of symptoms in all but the very mildest of patients. Until the advent of the leukotriene receptor antagonists, nearly all of these maintenance therapies needed to be administered by inhalation through a variety of devices and spacers. Inhalation of medication was necessary to either increase the amount of drug reaching the airways or to increase the therapeutic index of drugs such as corticosteroids. Even under the best circumstances, this route of administration is difficult and expensive for many parents whose children have asthma. Now that oral controller therapies (leukotriene receptor antagonists) are available for children, their role in clinical practice needs to be examined. The latest asthma management guidelines classify asthma into four groups of severity, and base treatment recommendations on the intensity of symptoms, need for rescue medications, and pulmonary function as measured by peak expiratory flow and forced expiratory volume in 1 sec (FEV(1)). The categories of mild intermittent, mild persistent, moderate persistent, and severe asthma in children will be addressed in this presentation by reviewing the available data on the use of the leukotriene receptor antagonist montelukast in children. Mild intermittent asthma can be typified by exercise-induced asthma, a common pediatric condition. In this often troublesome condition, montelukast demonstrated effectiveness at the end of a once a day dose by blocking the effects of this naturally occurring challenge. Drug regulatory approval of a new drug also includes patients with more regular symptoms who are usually classified as having persistent or moderate asthma. In these montelukast pediatric studies, approximately 40% of patients were already taking inhaled corticosteroids. Patients had improvements in FEV(1), symptoms, and rescue medication use, clearly showing an effect with once a day dosing. Pediatric data in severe asthma patients are more limited, but in such patients a therapeutic trial of montelukast would seem preferable to using systemic corticosteroids or increasing inhaled steroids to a level where adverse effects have an increasing potential of occurring. Montelukast has been available in the United States since March 1998 and has received excellent acceptance by physicians, parents, and patients. The 5-mg chewable tablet administered once a day in the evening in children aged 6-14 years apparently fills a previously unmet need in the treatment of pediatric asthma.

Acetates↗
PubMed2006

Randomised controlled trial of the efficacy of a metered dose inhaler with bottle spacer for bronchodilator treatment in acute lower airway obstruction.

BACKGROUND: Inhaled bronchodilator treatment given via a metered dose inhaler (MDI) and spacer is optimal for relief of bronchoconstriction. Conventional spacers are expensive or unavailable in developing countries, but there is little information on the efficacy of low-cost spacers in young children. OBJECTIVE: To compare the response to bronchodilator treatment given via a conventional or a low-cost bottle spacer METHODS: A randomised controlled trial of the efficacy of a conventional spacer compared with a bottle spacer for bronchodilator treatment in young children with acute lower airway obstruction. Bronchodilator treatment was given from an MDI via an Aerochamber or a bottle spacer. Clinical score and oximetry recording were carried out before and after 15 min of treatment. MDI-spacer treatment was repeated up to three times, depending on clinical response, after which nebulisation was used. The primary outcome was hospitalisation. RESULTS: 400 children, aged (median (25th-75th centile)) 12 (6-25) months, were enrolled. The number of children hospitalised (n = 60, 15%) was identical in the conventional and bottle spacer groups (n = 30, 15% in each). Secondary outcomes including change in clinical score (-2 (-3 to -1)), oxygen saturation (0 (-1 to 1)) and number of bronchodilator treatments (2 (1 to 3)) were similar in both groups. Oral corticosteroids, prescribed for 78 (19.5%) children, were given to a similar number in the conventional (37 (18.5%)) and bottle spacer groups (41 (20.5%)). CONCLUSION: A low-cost bottle spacer is as effective as a conventional spacer for bronchodilator treatment in young children with acute obstruction of the lower airways.

Asthma↗
PubMed1987

[Subcutaneous adrenaline versus inhaled salbutamol in the treatment of childhood asthmatic crisis].

As a bronchodilator, inhaled salbutamol has been shown to be as pharmacologically effective as epinephrine. However the use of the pressurised aerosol is difficult for pediatric patients (mainly under the age of six). The use of spacers (inhalation chambers) could solve this problem. This study was undertaken to compare the clinical effectiveness and toxicity of these two drugs and to try to establish dosage schedules of inhaled salbutamol with spacer in the treatment of acute asthma. The study population consisted of 100 children who were admitted to the emergency room at our hospital with acute asthma. One group receives 0.01 mg/kg of epinephrine (A) (maximum 0.3 mg), the other two groups received inhaled salbutamol (S-1 = 4 puffs and S-2 = 7 puffs) in a period of 20 minutes. Clinical effectiveness was measured by the score of Wood-Downes at 0, 30 and 60 minutes; and no statistical differences were observed between the three groups. The clinical effectiveness was similar in the three groups and the side effects (especially the increase of heart rate) was higher in epinephrine group. Inhaled salbutamol is as effective as subcutaneous epinephrine in management of children in acute bronchoconstricting episodes with less side effects.

Adolescent↗
PubMed2003

Performance of a corticosteroid inhaler with a spacer fashioned from a plastic cold-drink bottle: effects of changing bottle volume.

Some clinicians advocate using metered-dose inhaler (MDI) spacers prepared from common household bottles. We evaluated the in vitro aerosol characteristics of fluticasone from the MDI alone and through spacers fashioned from 237-, 500-, 1000-, and 1500-mL polyethylene terephlate plastic cold drink bottles using a cascade impactor. Ten 110-microg actuations of fluticasone were sampled into the impactor during each of five runs with each configuration. The primary outcomes were the respirable dose (i.e., quantity aerosol 1.1-4.7 microm in size) and the quantity trapped in the oropharynx. The mean fluticasone respirable dose from the MDI alone (46.2 microg/actuation) was no different (p > 0.05) compared with the same MDI mated to any of the bottle spacers, regardless of volume. The mean quantity of fluticasone trapped in the oropharynx from the MDI alone (39.2 microg/actuation) was greater (p < 0.001) than the same MDI mated with any bottle spacer (range 1.5-3.5 microg/actuation). These data suggest that any of the bottle spacers tested would be an acceptable method to decrease the quantity of fluticasone that would deposit onto the oropharynx and thereby diminish the risk of topical adverse effects. Among the range of volumes tested, there was no relationship between spacer volume and respirable dose of fluticasone.

Androstadienes↗
PubMed1994

Pulmonary deposition and clinical response of 99mTc-labelled salbutamol delivered from a novel multiple dose powder inhaler.

Pulmonary deposition of 99mTc-labelled sulbutamol was determined after delivery from a novel multiple dose powder inhaler (Easyhaler). The clinical efficacy of the inhalation powder, evaluated simultaneously with gamma camera detection, was compared with that obtained after drug delivery from a metered dose inhaler-spacer combination. The study was performed as an open, non-randomized cross-over trial. A single dose of radiolabelled inhalation powder was inhaled on the first and the inhalation aerosol, as control, on the second study day. Sulbutamol sulphate was labelled with 99mtechnetium, and the inhalation powder was formulated by mixing radioactive drug particles with carrier material. Aerodynamic properties of the radiolabelled inhalation powder were similar to those of the unlabelled salbutamol powder. Delivered dose from the breath-actuated powder inhaler was adjusted to be equal to two puffs from a conventional aerosol actuator with a short plastic mouthpiece. Twelve non-smoking asthmatic patients participated in the trial. The mean pulmonary deposition of 24% was obtained after drug delivery from Easyhaler powder inhaler. Clinical efficacy of the medications was similar in terms of area under the FEV1 curve, maximum FEV1 and the improvement ratio. Thus it can be suggested that powder delivery from Easyhaler powder inhaler and the aerosol delivery through the spacer are equally effective.

Adult↗
PubMed1993

Delivery of salbutamol by metered dose inhaler and valved spacer to wheezy infants: effect on bronchial responsiveness.

The efficacy of a new valved spacer device, the Babyhaler inhaler (Glaxo) for administering metered dose inhaler treatment via a facemask to infants was assessed. In a double blind, single dose study, salbutamol (800 micrograms) or placebo were given on separate days to 12 sedated, sleeping, wheezy infants during a symptom free interval. Lung function was measured before and after administration and the bronchial response to aerosol challenge with methacholine was then assessed using the squeeze technique. A small increase in heart rate and a drop in arterial oxygen tension followed salbutamol administration. No other change in lung volume or air flow obstruction was detected. Bronchial responsiveness decreased significantly after the administration of salbutamol by Babyhaler, the PC30 (provoking concentration of methacholine causing a 30% fall in maximal flow at functional residual capacity by the squeeze technique) increasing from a median of 3.8 g/l after placebo to 12.5 g/l after salbutamol. The Babyhaler is an effective device for administering bronchodilator to wheezy infants. The small scale of the response may be attributable to the uncertain effect of beta agonists in this population. Furthermore, pulmonary deposition of inhaled aerosols may be reduced in nose breathing, sleeping infants.

Albuterol↗
PubMed1985

Terbutaline by metered-dose inhaler: conventional inhaler versus tube spacer for children with asthma.

We compared terbutaline administered through an 80-mL, 10 X 3.2-cm tube spacer versus a conventional metered-dose inhaler in 34 asthmatic patients, aged 8 to 16 years. In this double-blind, single-dose study, three groups of children (spacer active, conventional active, and placebo) were assessed clinically and with spirometry before and at one-half hour intervals for two hours after therapy. One investigator taught inhaler use and monitored patients' errors in technique. Compared with placebo, terbutaline delivered by either the tube spacer or the conventional inhaler significantly improved pulmonary function from one-half to two hours after treatment. Both the spacer and conventional inhaler were equally effective in improving pulmonary function from the baseline state. Only 4/34 (11.7%) children used both inhalers without any error. Adverse effects were mild, transient, and infrequent and did not differ between the groups. Terbutaline aerosol, whether delivered by the tube spacer or conventional actuator, provides effective bronchodilation for children with asthma, in spite of frequent errors in technique of inhaler use.

Aerosols↗
PubMed1998

Handling of a spacer (Babyhaler) for inhalation therapy in 0- to 3-year-old children.

The handling of the Babyhaler spacer for inhalation therapy in children 0-3 years old with asthma was tested and the perceptions of the investigators with the instruction of this device to the parents was investigated. It was an open, multicenter study of 182 patients with a treatment period of 2 weeks and a 2-week follow-up period. Thirty pediatricians in Dutch local and university hospitals participated. Using a standardized instruction, the purpose and the application of the Babyhaler were explained and demonstrated, and parents were asked to use the Babyhaler on their own child. The quality of the demonstration was scored and, if necessary, additional instruction was given. In the following treatment period of 2 weeks record card was completed; the convenience score of the Babyhaler and the symptom score were recorded. At the following evaluation visit the handling of the Babyhaler by the parents was re-evaluated. Eighty-nine percent of the parents could use the Babyhaler correctly after one instruction. The instructions of the Babyhaler were considered to be easy in 83% of the cases by the parents and the investigators. During the treatment period the handling score (6 = impossible to use, 1 = very easy) improved from 2.4 to 1.7. At the evaluation visit the correct use was similar to the result at the instruction visit (87%). No differences were found in the ease of handling between the three age groups (0-1, 1-2, and 2-3 years). The application of inhalation therapy via the Babyhaler was favored by 92% of the parents as compared to the former treatment method. We demonstrated that the Babyhaler is easy to use by the parents and that the instruction of the device by practitioners is also perceived as easy.

Asthma↗
PubMed2002

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

BACKGROUND: 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. OBJECTIVE: 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). METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Absorption↗
PubMed1996

Adrenal suppression among asthmatic children receiving chronic therapy with inhaled corticosteroid with and without spacer device.

BACKGROUND: Inhaled corticosteroids have become a first-line treatment for chronic asthma. It has been shown that inhaled corticosteroids can have a measurable effect on the hypothalamic-pituitary-adrenal axis in asthmatic children. OBJECTIVE: To investigate the prevalence of adrenal suppression among asthmatic children receiving chronic therapy with low to moderate doses (up to 1000 micrograms) of inhaled beclomethasone dipropionate via a metered dose inhaler (MDI) and via MDI attached to a spacer device (MDI-spacer). METHODS: The study included 39 asthmatic children currently undergoing therapy; 24 received beclomethasone dipropionate by MDI attached to a spacer, and 15 directly by MDI. All the patients had been treated for at least 4 months. Another 21 children were normal controls. The 24-hour urinary free cortisol excretion was measured to evaluate hypothalamic-pituitary-adrenal axis function. RESULTS: Seven of 15 (47%) patients from the MDI group had reduced 24 hour-urinary free cortisol excretion and 2 of 24 (8%) in the MDI-spacer group (P = .006). The mean 24-hour urinary free cortisol excretion of the MDI group was 0.0185 +/- 0.0089 microgram/gram creatinine, and the MDI-spacer and the control groups were, 0.0290 +/- 0.0138 microgram/gram creatinine and 0.0270 +/- 0.0118 microgram/gram creatinine, respectively, (P = 0.37, f = 3.51 ANOVA). CONCLUSION: Chronic inhalation of low to moderate doses of corticosteroids is associated with adrenal suppression in some asthmatic children. This side effect is more common among patients inhaling directly from the MDI and is less frequent when a large volume spacer is attached to the MDI.

Administration, Inhalation↗
PubMed1991

Optimizing drug delivery from metered-dose inhalers.

Metered-dose inhalers (MDIs) are being used with increasing frequency to administer medication used in the treatment of respiratory tract disorders. Inhaled medication is delivered directly to the tracheobronchial tree, allowing for a rapid and predictable onset of action. Studies show that only about ten percent of the dose from an MDI actually reaches the lung. The site of deposition within the lung is influenced by the aerosol characteristics, interpatient variability, and the technique by which the patient uses the inhaler. Spacer devices have been designed to overcome some of the problems encountered with MDIs and may be beneficial in certain groups of patients. The studies reviewed in this article suggest ways to alter the variables affecting inhalation in order to optimize drug delivery so that the patient will obtain the most benefit from the inhaled medication.

Administration, Inhalation↗
PubMed1990

[Effect of a spacer device used with metered dose inhaler].

Metered dose inhaler (MDI) is widely used in treatment of bronchial asthma. But adequate efficacy is not obtained if the patients use an improper technique of inhalation. The spacer device was designed to reduce such inhalation errors. Three types of spacers (pear type, tube type, paper spacer) were studied to confirm their usefulness in bronchial asthma. Bronchodilating effect of procaterol (10 micrograms/puff X 2) in conventional MDI or MDI with a spacer was evaluated. There were no significant difference in the effect on the pulmonary function after single inhalation of MDI with or without a spacer for 60 minutes. In regular use of MDI with a spacer for two weeks, PEFR and FEV1.0 were slightly improved. These results suggest that effect of MDI with a spacer may be more effective than MDI alone in regular use.

Administration, Inhalation↗
PubMed1987

A comparison of inhaled budesonide and beclomethasone dipropionate in childhood asthma.

The objective of this study was to compare the clinical effects of beclomethasone dipropionate (BDP) and budesonide in asthmatic children using two common ways of administration. Twenty-one children, aged 4-14 years, who regularly used inhaled corticosteroids for their control of asthma were included in the study. The drugs were studied by using a double-blind randomized cross-over design trial with a single-blind placebo period at the end. Each period lasted 3 weeks. The dosage was 100 micrograms b.i.d. for both drugs. Budesonide was administered via a spacer inhaler (Inhalet), and beclomethasone dipropionate via a standard actuator. Compared with placebo, both drugs significantly improved PEFR values for morning (20% for budesonide and 14% for BDP) and evening (14% for budesonide and 9% for BDP). Both morning and/or evening peak flows were significantly higher during the budesonide treatment as compared with the BDP treatment. In comparison with the placebo period, FEV1.0 was significantly improved with budesonide but not with BDP. Plasma cortisol, WBC counts, differential and eosinophilia counts in blood were determined at the beginning and the end of each period. All of the values except for the eosinophil counts were within normal ranges. Candida was looked for but not found in any case. No other adverse effects were registered. For most of the children, a deterioration of the state of their asthma and increased need for concomitant therapy during the placebo period confirmed their steroid dependence. The number of administrations with concomitant anti-asthmatic therapy increased during placebo by 61% as compared with the budesonide therapy, and by 40% compared with the BDP therapy.

Administration, Inhalation↗
PubMed1984

Therapeutic advantages of twice-daily over four-times daily inhalation budesonide in the treatment of chronic asthma.

Topical steroid therapy is now widely used in the treatment of chronic asthma, but few controlled studies have been conducted to evaluate the most efficient dosage regimen. The present study was designed to assess, in a double-blind fashion, the relative efficacy of a new topical steroid, budesonide (Pulmicort) in controlling pulmonary function and asthma symptoms during twice-and 4-times daily dosing. Both active and placebo drug were administered via the tube spacer inhaler. Objective lung function measurements indicate that twice-daily dosing is at least as effective as 4-times daily dosing, and it is suggested that the twice-daily dosage regimen may lead to better patient compliance.

Aerosols↗
PubMed1999

Effectively managing asthma in young and middle adulthood.

Revised national guidelines for managing asthma in nonpregnant young adults and adults stress education for self-management and include provisions for stepped care. These guidelines also include education on asthma pathophysiology; measures to control exacerbations; medications available to treat the disease; use of inhalers, spacers, holding chambers and self-monitoring; and peak expiratory flow meters. Treatment is based on frequency of exacerbations and readings from the peak flow meter. The stepped-care approach means aggressively treating patients at a higher step than current signs and symptoms may warrant, to gain rapid control over these signs and symptoms. The new guidelines suggest that patients with intermittent asthma use inhaled, short-acting bronchodilators, whereas those with persistent asthma should begin with daily inhaled, antiinflammatory medicines. Once control is maintained for weeks or months, dosages can gradually be reduced to the minimum effective level.

Adolescent↗
PubMed2003

The administration of beta2-agonists for paediatric asthma and its adverse reaction in Australian and New Zealand emergency departments: a cross-sectional survey.

AIM: To determine the current use of beta2-agonists, in particular salbutamol, for the management of acute asthma in children in emergency departments throughout Australia and New Zealand. METHODS: A cross-sectional survey using a questionnaire that sought to determine the current use of salbutamol and any adverse drug reactions in paediatric emergency departments. RESULTS: Out of 37 hospitals eligible as paediatric emergency departments, 33 (89.1%) responded to the survey, 54.5% having guidelines for the management of acute asthma. Of the paediatric emergency departments surveyed, 45.5% used metered-dose inhaler spacer combination in the treatment of mild to moderate asthma. All paediatric emergency departments used nebulized salbutamol for acute severe asthma. In addition, 85% of paediatric emergency departments used continuous-infusion intravenous salbutamol in unresponsive patients, 63.6% administering a single-dose intravenous salbutamol bolus before commencing the infusion. District paediatric emergency departments were more likely to treat with continuous-infusion intravenous salbutamol outside of the intensive care unit. Clinical unresponsiveness to inhaled salbutamol and clinical improvement were the reported criteria in all paediatric emergency departments for the use and cessation of intravenous salbutamol. Adverse drug reactions were common: tremor (90%), hypokalaemia (45.5%) and supraventricular tachycardia (21%), particularly if continuous-infusion intravenous salbutamol administered. Eight deaths from asthma were reported, none being related to adverse drug reactions. CONCLUSION: We report a wide variation of salbutamol use in paediatric emergency departments and a high prevalence of type A adverse drug reactions when continuous-infusion intravenous salbutamol therapy was administered. More evidence is needed on the clinical significance of the adverse effects reported in this study and optimal doses for the safe use of continuous-infusion intravenous salbutamol therapy in paediatric emergency departments.

Adolescent↗
PubMed1996

Comprehensive long-term management program for asthma: effect on outcomes in adult African-Americans.

To determine if a comprehensive long-term management program, emphasizing inhaled corticosteroids and patient education, would improve outcomes in adult African-American asthmatics a nonrandomized control trial with a 2-year intervention was performed in a university-based clinic. Inclusion criteria consisted of (> or = 5) emergency department (ED) visits or hospitalizations (> or = 2) during the previous 2 years. Intervention patients were volunteers; a comparable control group was identified via chart review at hospitals within the same area and time period as the intervention patients. Individualized doses of beclomethasone with a spacer, inhaled albuterol "as needed," and crisis prednisone were the primary therapies. Environmental control, peak flow monitoring, and a partnership with the patient were emphasized. Detailed patient education was an integral part of management. Control patients received usual care from local physicians. ED visits and hospitalizations for 2 years before and 2 years during the intervention period were compared. Quality of life (QOL) measurements were made at baseline and every 6 months in the intervention group. Study group (n = 21) had a significant reduction in ED visits (2.3 +/- 0.2 pre-intervention versus 0.6 +/- 0.2 post-intervention; P = 0.0001). Control group (n = 18) did not have a significant change in ED visits during the 2-year post-intervention period (2.6 +/- 0.2 pre-intervention versus 2.0 +/- 0.2 post-intervention; P = 0.11). Both groups had significant reductions in hospitalizations, but the study group had a greater reduction. Sixty-two percent of study patients had complete elimination of ED visits and hospitalizations, whereas no control patients had total elimination of the need for institutional acute care. QOL in the study patients revealed significant improvements for most parameters. A comprehensive long-term management program emphasizing inhaled corticosteroids combined with other state-of-the-art management, including intensive patient education, improves outcomes in adult African-American asthmatics.

Adrenal Cortex Hormones↗