A randomised controlled trial to assess the relative benefits of large volume spacers and nebulisers to treat acute asthma in hospital. Home-made spacers for bronchodilator therapy in children with acute asthma: a randomised trial. Treatment of acute asthma: salbutamol via jet nebuliser vs spacer and metered dose inhaler. Randomised trial spacer v nebuliser for acute asthma. Randomised controlled trial of the efficacy of a metered dose inhaler with bottle spacer for bronchodilator treatment in acute lower airway obstruction. Comparative efficiency of commercial and improvised spacer device in acute bronchial asthma. Metered-dose inhalers with spacers vs nebulizers for pediatric asthma. Costs and effectiveness of spacer versus nebulizer in young children with moderate and severe acute asthma. High-dose albuterol by metered-dose inhaler plus a spacer device versus nebulization in preschool children with recurrent wheezing: A double-blind, randomized equivalence trial. Comparative efficacy of jet nebulizer and metered dose inhaler with spacer device in the treatment of acute asthma. Efficacy of a home-made spacer with acute exacerbation of bronchial asthma: a randomized controlled trial.
To compare the clinical effectiveness, acceptability, and cost benefit of administering beta2 agonists by means of a metered dose inhaler and large volume spacer with conventional nebulisers to children admitted to hospital with acute asthma.
                A randomised controlled trial was conducted over five months. Sixty one children older than 3 years admitted to a large teaching hospital and a district general hospital with acute asthma completed the study. Children received either 5 mg of salbutamol up to one hourly by jet nebuliser, or up to 10 puffs of salbutamol 100 microg by means of a metered dose inhaler and spacer up to one hourly.
                Median hospital stay was 40 hours in the nebuliser group and 36.5 hours in the spacer group. Asthma disability scores at two weeks after discharge were significantly improved in the spacer group. Drug costs were pound 14.62 less for each patient in the spacer group.
                Large volume spacers are an acceptable, cost effective alternative to nebulisers in treating children admitted with acute asthma, provided that the children can use the mouthpiece, and symptoms are not severe. Their use facilitates effective home treatment by parents, with subsequent reduction in morbidity and re-admission rates. A metered-dose inhaler (MDI) with spacer is the best way to deliver bronchodilator therapy for treatment of acute asthma. In developing countries, commercially produced spacers are generally unavailable or too costly. We tested the efficacy of home-made spacers (500 mL plastic bottle, polystyrene cup) compared with a conventional spacer for delivery of a beta2 agonist via MDI for children with acute asthma.
                We studied children aged 5 to 13 years with acute asthma, stratified into those with mild airways obstruction (peak expiratory flow [PEF] 60-79% of predicted value) or moderate to severe airways obstruction (PEF 20-59% of predicted value). A beta2 agonist (fenoterol hydrobromide) was given via MDI and one of four randomly assigned spacers (conventional spacer, sealed 500 mL plastic bottle, unsealed 500 mL bottle, 200 mL polystyrene cup). Clinical score, pulmonary function tests, and oximetry were recorded at baseline and 15 min after treatment. If a second bronchodilator treatment was needed, nebulised fenoterol was given and the assessment repeated 15 min later. Primary outcome measures were changes in clinical score and pulmonary function, and need for and response to nebulisation.
                88 children were eligible for study. In 44 children with moderate to severe airways obstruction, a cup gave significantly less bronchodilation (median increase in: forced expiratory volume in 1 s [FEV1] 0%; PEF 12%) compared with the conventional spacer (37%; 59%), sealed bottle (33%; 36%), or unsealed bottle (18%; 21%, p<0.05 for difference between groups). Nebulisation was required by ten of 11 who had used a cup, nine of 11 who had used an unsealed bottle, eight of 11 who had used a sealed bottle, and only four of 11 who had used a conventional spacer. After nebulisation, improvement in FEV1 (15.5%) and PEF (26%) was more marked in children who had used a cup than in those who had used a conventional spacer (5.5% FEV1; 4% PEF), sealed bottle (3%; 0%), or unsealed bottle (7%; 9%). For 44 children with mild airways obstruction, response to bronchodilator was similar for all spacers and need for nebulisation was not associated with use of a particular spacer.
                A conventional spacer and sealed 500 mL plastic bottle produced similar bronchodilation, an unsealed bottle gave intermediate improvement in lung function, and a polystyrene cup was least effective as a spacer for children with moderate to severe airways obstruction. Use of bottle spacers should be incorporated into guidelines for asthma management in developing countries. 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.
                A total of 160 children aged from 4 to 12 years presenting to an Emergency Department with acute asthma.
                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.
                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).
                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. Sixty hospitalised children with asthma aged 1-5 years were randomised to spacer or nebuliser. A clinical score was measured at baseline and every 12 hours. There were no differences between groups in the score over time, or secondary outcome measures. The spacer is an effective delivery method for young hospitalised asthmatic children. 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.
                To compare the response to bronchodilator treatment given via a conventional or a low-cost bottle spacer
                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.
                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%)).
                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. To compare the efficacy of a commercial spacer device versus an improvised spacer device in delivering aerosolized beta-2 agonist through metered dose inhaler in an acute exacerbation of bronchial asthma.
                Randomized controlled trial.
                Urban tertiary care teaching hospital.
                60 children between 1 to 12 years of age with acute asthma were prospectively enrolled and randomized into two groups. Detailed history, clinical evaluation and appropriate laboratory investigations were recorded on a pretested proforma. One group received inhaled salbutamol using metered dose inhaler via commercial spacer device (Group 1), while the other received it via improvised spacer device (Group II). The response was sequentially assessed after 20, 40 and 60 minutes of institution of therapy.
                The two groups were comparable with respect to various parameters at presentation (p > 0.05). All the outcome parameters showed a significant improvement with time in both groups (p < 0.05). There was no statistical difference between the response in the two groups (p< 0.05).
                Metered dose inhaler with improvised spacer device is equivalent in efficacy and a more cost effective alternative to metered dose inhaler with commercial spacer for administration of beta-2 agonist in acute asthma. To determine whether the administration of beta-agonists by metered-dose inhaler (MDI) with a spacer device is as effective as the administration of beta-agonists by nebulizer for the treatment of acute asthma exacerbations in children.
                Randomized trial with two arms.
                Urban pediatric emergency department (ED) in Bronx, NY.
                Convenience sample of 152 children 2 years and older with a history of at least two episodes of wheezing presenting to the ED with an acute asthma exacerbation.
                Patients were randomly assigned to receive standard doses of a beta-agonist (albuterol) by an MDI with spacer or by a nebulizer. Dosing intervals and the use of other medications were determined by the treating physician.
                Baseline characteristics and asthma history were recorded. Asthma severity score, peak expiratory flow rate in children 5 years or older, and oxygen saturation were determined at presentation and before admission or discharge. The groups did not differ in age, sex, ethnicity, age of onset of asthma, or asthma severity score at presentation. There were no significant differences between the groups in outcomes, including mean changes in respiratory rate, asthma severity score, and peak expiratory flow rate, oxygen saturation, number of treatments given, administration of steroids in the ED, and admission rate. Patients given MDIs with spacers required shorter treatment times in the ED (66 minutes vs 103 minutes, P < .001). Fewer patients in the spacer group had episodes of vomiting in the ED (9% vs 20%, P < .04), and patients in the nebulizer group had a significantly greater mean percent increase in heart rate from baseline to final disposition (15% vs 5%, P < .001).
                These data suggest that MDIs with spacers may be an effective alternative to nebulizers for the treatment of children with acute asthma exacerbations in the ED. To compare the costs and effectiveness of albuterol by metered dose inhaler (MDI) and spacer versus nebulizer in young children with moderate and severe acute asthma.
                Randomized, double-blind, placebo-controlled trial in an emergency department at a children's hospital. The participants were children 1 to 4 years of age with moderate to severe acute asthma. Patients assigned to the spacer group received albuterol (600 microg) by MDI by spacer (AeroChamber) followed by placebo by nebulizer (n = 30). The nebulizer group received placebo MDI by spacer followed by 2.5 mg albuterol by nebulizer (n = 30). Treatments were repeated at 20-minute intervals until the patient was judged to need no further doses of bronchodilator, or a total of 6 treatments.
                Clinical score, heart rate, respiratory rate, auscultatory findings, and oxygen saturation were recorded at baseline, after each treatment, and 60 minutes after the last treatment. Baseline characteristics and asthma severity were similar for the treatment groups. The spacer was as effective as the nebulizer for clinical score, respiratory rate, and oxygen saturation but produced a greater reduction in wheezing (P =.03). Heart rate increased to a greater degree in the nebulizer group (11.0/min vs 0.17/min for spacer, P <.01). Fewer children in the spacer group required admission (33% vs 60% in the nebulizer group, P =.04, adjusted for sex). No differences were seen in rates of tremor or hyperactivity. The mean cost of each emergency department presentation was NZ$825 for the spacer group and NZ$1282 for the nebulizer group (P =.03); 86% of children and 85% of parents preferred the spacer.
                The MDI and spacer combination was a cost-effective alternative to a nebulizer in the delivery of albuterol to young children with moderate and severe acute asthma. Inhaled albuterol is the most frequently used bronchodilator for acute wheezing, and nebulization is the standard mode of delivery in hospital setting. However, recent guidelines consider spacer devices as an easier to use, and cost-saving alternative and recommend the high-dose metered-dose inhaler bronchodilator.
                To demonstrate clinical equivalence between a spacer device and a nebulizer for albuterol administration.
                Randomized, double-blind, parallel group equivalence trial.
                Pediatric emergency wards at 2 tertiary teaching hospitals.
                Sixty-four 12- to 60-month-old children with acute recurrent wheezing (32 per group).
                Albuterol was administered through the spacer device (50 microg/kg) or through the nebulizer (150 microg/kg) and repeated 3 times at 20-minute intervals. Parents completed a questionnaire.
                Pulmonary index, hospitalization, ease of use, acceptability, and pulse oximetry saturation.
                The 90% confidence interval of the difference between treatment groups for the median absolute changes in pulmonary index values between T0 and T60 was [-1; +1] and was included in the equivalence interval [-1.5; +1.5]. Clinical improvement increased with time. Less than 10% of the children (3 in each group) required hospitalization (2 in each group attributable to treatment failure). Parents considered administration of albuterol using the spacer device easier (94%) and better accepted by their children (62%).
                The efficacy of albuterol administered using the spacer device was equivalent to that of the nebulizer. Given its high tolerance, repeated 50-microg/kg doses of albuterol administered through the spacer device should be considered in hospital emergency departments as first-line therapy for wheezing. To compare the relative efficacy of jet nebulizer and metered dose inhaler (MDI) with spacer for the administration of aerosolized salbutamol in an acute exacerbation of bronchial asthma.
                Randomized prospective study.
                Emergency Room.
                In 60 subjects with acute asthma aged between 1 to 12 years, clinical and laboratory assessment of severity at recruitment included heart rate, respiratory rate, pulsus paradoxus, arterial blood gas analysis (all cases) and peak expiratory flow rate (wherever possible). The subjects were randomized into two equal groups to receive aerosolized salbutamol either via nebulizer (Group I) or MDI-spacer (Group II) as per the Consensus Guidelines. The response to therapy was sequentially assessed after 20, 40 and 60 minutes of institution of therapy.
                A significantly (p < 0.02) greater number of subjects in Group II presented with severe dyspnea and intercostal muscle retraction (subjective assessment). However, the objectively evaluable outcome parameters were comparable (p > 0.05) in both groups at presentation. All the outcome measures showed a significant (p < 0.05) improvement with time in both the groups. The recovery parameters were comparable (p > 0.05) at different time periods in the two groups.
                MDI-spacer is as effective as a nebulizer for the aerosolized administration of salbutamol in an acute exacerbation of asthma in children. However, for developing countries, distinct advantages (economic and power requirement) argue strongly for utilization of MDI-spacer in preference to nebulizer. Metered dose inhaler (MDI) with spacer is the preferred method for administration of aerosolized medications in pediatric asthma. The expense of commercial spacers limits their use and indigenous alternatives have therefore been developed. Information on the clinical efficacy of home-made spacers is limited. This study was conducted to compare the efficacy of a valve-less home-made spacer with a commercial spacer in delivering salbutamol via MDI in acute asthma. Asthmatic children aged 5-15 years who presented with an acute exacerbation to the pediatric chest clinic of a tertiary care hospital were enrolled in a single blinded randomized parallel group study. The study patients received 10 puffs of salbutamol (100 microg/puff) via MDI-home-made spacer or MDI-commercial spacer. Pre and post inhalation measurements of peak expiratory flow rate (PEFR), oxygen saturation (SaO2), respiratory rate (RR), pulse rate (PR) were made and compared. Sixty children were enrolled in the study, 31 were administered salbutamol via the home-made spacer and 29 via the commercial spacer. The median increase in PEFR was similar in both the groups (20.8% vs 22.2%, p=0.4), clinical improvement being satisfactory in all patients. The valve-less home-made spacer is equally efficacious and cheaper than the commercial spacer in administering bronchodilators in acute exacerbations of asthma. Further studies on the efficacy of home-made spacer in delivery of inhaled steroids are needed.
Metered-dose inhalers with spacer produced outcomes that were at least equivalent to nebuliser delivery. Spacers may have some advantages compared to nebulisers for children with acute asthma.