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PubMed2001

Systematic review of clinical effectiveness of pressurised metered dose inhalers versus other hand held inhaler devices for delivering corticosteroids in asthma.

OBJECTIVE: To determine the clinical effectiveness of pressurised metered dose inhalers (with or without spacer) compared with other hand held inhaler devices for the delivery of corticosteroids in stable asthma. DESIGN: Systematic review of randomised controlled trials. DATA SOURCES: Cochrane Airways Group trials database (Medline, Embase, Cochrane controlled clinical trials register, and hand searching of 18 relevant journals), pharmaceutical companies, and bibliographies of included trials. TRIALS: All trials in children or adults with stable asthma that compared a pressurised metered dose inhaler with any other hand held inhaler device delivering the same inhaled corticosteroid. RESULTS: 24 randomised controlled trials were included. Significant differences were found for forced expiratory volume in one second, morning peak expiratory flow rate, and use of drugs for additional relief with dry powder inhalers. However, either these were within clinically equivalent limits or the differences were not apparent once baseline characteristics had been taken into account. No significant differences were found between pressurised metered dose inhalers and any other hand held inhaler device for the following outcomes: lung function, symptoms, bronchial hyper-reactivity, systemic bioavailability, and use of additional relief bronchodilators. CONCLUSIONS: No evidence was found that alternative inhaler devices (dry powder inhalers, breath actuated pressurised metered dose inhalers, or hydrofluoroalkane pressurised metered dose inhalers) are more effective than the pressurised metered dose inhalers for delivery of inhaled corticosteroids. Pressurised metered dose inhalers remain the most cost effective first line delivery devices.

Adult↗
PubMed1991

Effect of a volumatic spacer and mouth rinsing on systemic absorption of inhaled corticosteroids from a metered dose inhaler and dry powder inhaler.

BACKGROUND: High doses of inhaled corticosteroids are absorbed systemically and may cause long term side effects. As rinsing the mouth out after use and inhaling through a spacing device may reduce systemic absorption this has been further investigated. METHODS: Three crossover studies were carried out to assess the effect of budesonide given by dry powder inhaler (Turbuhaler) with and without mouth rinsing and beclomethasone dipropionate given by metered dose inhaler with or without a spacing device (Volumatic) on serum cortisol concentrations and urinary cortisol excretion in patients with asthma taking an inhaled corticosteroid. Each treatment period was two weeks with in a two week washout period. Serum cortisol concentrations at 0800 hours on day 14 and the 24 hour urinary excretion of cortisol were measured. In study 1 24 patients taking beclomethasone dipropionate 500 micrograms twice a day inhaled with (n = 10) or without (n = 14) a Volumatic spacing device were switched to a budesonide dry powder inhaler, 600 micrograms to be taken twice a day without mouth rinsing. In study 2 10 patients took budesonide 800 micrograms twice a day with and without mouth rinsing and without swallowing the rinsing water. In study 3 17 patients took budesonide 800 micrograms twice daily with mouth rinsing and beclomethasone dipropionate 500 micrograms twice daily with the spacing device and mouth rinsing. RESULTS: In study 1 no difference was seen between budesonide without mouth rinsing and beclomethasone dipropionate without a spacer: beclomethasone with spacer caused less suppression of cortisol (mean (SD) serum cortisol concentration: beclomethasone and spacer 487(148), budesonide 368(145) nmol/l). In study 2 mouth rinsing caused less suppression of morning serum cortisol concentrations (rinsing 440(63), no rinsing 375(56) nmol/1). In study 3 there was no difference in serum or urinary cortisol concentrations between twice daily beclomethasone dipropionate 500 micrograms inhaled by Volumatic spacer or budesonide by Turbuhaler 800 micrograms twice daily, both with mouth rinsing. Individual serum cortisol values were within the normal range in all patients except one in study 1. CONCLUSION: Systemic absorption of a corticosteroid inhaled from a metered dose inhaler is reduced by using a spacing device and that from a dry powder inhaler by mouth rinsing.

Administration, Inhalation↗
PubMed1994

Reduction of morbidity in asthmatic children given a spacer device.

STUDY OBJECTIVE: To evaluate whether providing a spacer device and a single, brief demonstration regarding its proper use would result in earlier resolution of asthma symptoms, improved school attendance, and decreased frequency of unscheduled medical visits for asthma among children receiving noncontinuous care in an urban emergency department (ED). DESIGN: Randomized controlled trial. SETTING: Urban hospital pediatric ED. PARTICIPANTS: Eighty-four children with the chief complaint of asthma. INTERVENTION: Children were enrolled in the ED at the time of an asthma attack and randomly assigned to one of two treatment groups. The spacer group received an inhaled beta-agonist at discharge from the ED with a spacer device. The control group received inhaled or oral beta-agonists without a spacer device. Both groups received other medications at the discretion of the evaluating physician who was not the interviewer in any case. A baseline questionnaire was completed and follow-up by telephone was done at 1 week, and 2, 4, and 6 months after enrollment. MEASUREMENTS AND RESULTS: The spacer group reported significantly earlier resolution of wheezing (0 days vs 2 days, p < 0.01) at the 2- and 4-month follow-up assessments. They reported significantly fewer days of cough after an asthma attack at 2 months (1 day vs 3 days, p < 0.01) and 4 months (0 days vs 3 days, p < 0.01). The spacer group missed significantly fewer days of school following an asthma attack at 2 and 4 months (0 days vs 2 days, p = 0.05). There was no difference between the two groups on any outcome measures at the 1-week and 6-month follow-up assessments. CONCLUSIONS: Introducing a spacer device to patients in a busy, inner-city pediatric ED is an effective and efficient intervention that improves the functioning of asthmatic children in terms of resolution of cough and wheeze and school absenteeism.

Absenteeism↗
PubMedDate not supplied

Comparison of oral-steroid sparing by high-dose and low-dose inhaled steroid in maintenance treatment of severe asthma.

It is not clear whether high doses of inhaled steroids have a greater sparing effect than low doses on the requirement for systemic steroids. In a randomised, double-blind, multicentre study, we compared the effects of high-dose (1500 micrograms/day) and low-dose (300 micrograms/day) inhaled beclomethasone dipropionate (BDP) in patients with severe asthma requiring a daily oral prednisolone dose of 10-40 mg. During a 3-month run-in period, we tried to achieve optimum asthma control by means of oral steroid and inhaled BDP 300 micrograms/day. The patients were then allocated to high-dose (n = 71) or low-dose (n = 72) treatment by an independent observer who took into account various prognostic factors. BDP was administered by means of an aerosol inhaler with a spacer device. The dose of systemic steroid was reduced as much as possible during the 6-month study period while keeping the peak expiratory flow (PEF) constant and asthma clinically stable. There was no difference between the low-dose and high-dose treatment groups in the mean reduction in oral prednisolone dose achieved by the end of the study (5.2[ SD 7.9] vs 5.0 [9.4] mg/day). The maximum response to inhaled steroid was seen, however, only after several months' therapy in both groups. There were no differences between the groups in use of on-demand beta-agonist inhalations or in asthma symptoms, and PEF values were constant throughout the study. Both doses of BDP were well tolerated. High doses of inhaled steroid offer no further benefit over low doses in the maintenance treatment of severe steroid-dependent asthma when the inhaled steroid is administered with a spacer device.

Administration, Inhalation↗
PubMed1996

Effect of paper spacer (spader) in conjunction with procaterol metered dose inhaler in the treatment of acute asthma.

Thirty acute asthmatic patients (mean age 35.6 +/- 13.5 years, mean FEV1 0.97 +/- 0.95 L) in the emergency room were evaluated for airway response to procaterol administered by metered-dose inhaler (MDI) compared to MDI with auxiliary device (a paper spacer) in a randomised cross over study. Bronchodilator response to procaterol delivered by MDI, with paper spacer was significantly greater than that by MDI without spacer (mean maximal increment of FEV1, 0.67 +/- 0.46 vs 0.59 +/- 0.46 L, p = 0.016, mean maximal increment of PEFR, 112 +/- 62.3 vs 86.7 +/- 61.3 L/min, p = 0.003) but there was no difference in dyspnoea score, wheezing score and heart rate. This collapsible and portable auxiliary device (paper spacer) can increase therapeutic efficacy of bronchodilator response in asthmatic patients.

Acute Disease↗
PubMed2002

Two administration methods for inhaled salbutamol in intubated patients.

AIMS: To compare serum concentrations and effects on respiratory mechanics and haemodynamics of salbutamol administered by small volume nebuliser (SVN) and metered dose inhaler (MDI) plus spacer. METHODS: Blinded, randomised, crossover study in 12 intubated infants and children (mean age 17.8 months) receiving inhaled salbutamol therapy. Subjects received salbutamol as 0.15 mg/kg by SVN and four puffs (400 microg) by MDI plus spacer at a four hour interval in random order. Passive respiratory mechanics were measured by a single breath/single occlusion technique, and serum salbutamol concentrations by liquid chromatography-mass spectrometry at 30 minutes, 1, 2, and 4 hours after each dose. Haemodynamics (heart rate and blood pressure) were recorded at each measurement time. RESULTS: There was no difference in percentage change in respiratory mechanics or haemodynamics between the two methods of administration. Mean area under the curve (AUC(0-4)) was 5.86 for MDI plus spacer versus 4.93 ng/ml x h for SVN. CONCLUSIONS: Serum concentrations and effects on respiratory mechanics and haemodynamics of salbutamol were comparable with the two administration methods under the conditions studied. Future studies are needed to determine the most effective and safe combination of dose and administration method of inhaled salbutamol in mechanically ventilated infants and children.

Albuterol↗
PubMed1995

Educational and long-term therapeutic intervention in the ED: effect on outcomes in adult indigent minority asthmatics.

Minorities have increased morbidity and mortality rates resulting from asthma. The segment of minorities that is socioeconomically depressed often uses the emergency department (ED) as their primary site of medical care. For these reasons, we provided major long-term therapeutic intervention as well as intensive education in the ED for indigent adult African American asthmatics. We intervened in the cases of 30 patients who were frequent visitors to the ED over the previous 2 years. The intervention consisted of 1 hour of education in the ED before discharge regarding the prevention of asthma, the importance of decreasing inflammation as a means of improving asthma control, self-monitoring with a peak flow meter, and a demonstration of correct inhalation technique with metered-dose inhalers and a spacer device. Further, the intervention included management consistent with recent NIH Guidelines, stressing inhaled corticosteroids. After the intervention in the ED, patients were scheduled for follow-up asthma clinic visits. Outcome measures were ED visits and hospitalizations for 1 year after the ED intervention. Using the same inclusion/exclusion criteria, a retrospective control group of 22 patients for the same time period was compared with the intervention group. Before our intervention, the mean number of ED visits per patient for the previous 2 years was 4.4 +/- 2.7, and after the intervention, 2.6 +/- 2.6 (P < .01). The control group did not show a difference in the number of ED visits (3.4 +/- 2.6 before and 3.5 +/- 2.7 after, P = .96). After the intervention, the mean number of hospitalizations decreased significantly in the study group (P < .01).(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed2001

On the use of dry powder inhalers in situations perceived as constrained.

Dose delivery from dry powder inhalers (DPIs) are dependent on the inhalation effort of the patient. Some patient groups, including asthmatic children, patients with acute asthma, and patients with advanced chronic obstructive pulmonary disease (COPD) are perceived as having problems in readily inhaling from a DPI in an efficient way; this opinion is based on alleged low inhalation flows. A review of the literature however shows that these groups can use a DPI in an efficient way and gain good clinical effect from its use. Particularly, it has been shown that children can generate a good peak inhalation flow through a DPI, albeit a lower inhaled volume. Similarly, patients with acute asthma can use a DPI in an efficient way, even reaching a better clinical effect with the DPI than with a pressurized metered dose inhaler with a spacer. Finally, it was shown that patients with severe COPD can generate the inhalation flows needed to generate an efficient drug aerosol from a DPI. Collectively, the discussed patient groups seem to perform as well as other subjects when it comes to their ability to generate an adequate inhalation flow through a DPI.

Adult↗
PubMed1995

Comparison of Bricanyl Turbuhaler and Ventolin Rotahaler in children with asthma.

BACKGROUND: Pulmonary administration of beta 2-agonists by means of pressurized metered dose inhaler is widely used in the treatment of asthma. Young children have difficulties in using these inhalers unless a spacer device is used. To overcome this problem inspiratory flow driven dry powder inhalers have been developed. OBJECTIVE: The aim of this study was to compare the efficacy and safety of the two powder inhalers Bricanyl Turbuhaler (terbutaline sulphate 0.5 mg t.i.d.) and Ventolin Rotahaler (salbutamol 0.4 mg t.i.d.) in 20 children 2 to 6 years old with mild to moderate asthma. METHODS: The study had an open randomized crossover design with 1 week run-in without treatment and the two treatment periods of 2 weeks each. Efficacy was measured with peak expiratory flow determination, asthma symptom scores, and need for rescue medication. Adverse events were recorded. RESULTS: Peak expiratory flow increased significantly (P < .001) after both treatments. There were no statistically significant differences in peak expiratory flow, asthma symptom scores, need for extra inhalations, or adverse events between the devices. Most children (parents) preferred the Turbuhaler. CONCLUSION: Both Bricanyl Turbuhaler and Ventolin Rotahaler seem to be effective and well tolerated in the treatment of asthma in preschool children. Of special interest is that even the youngest children in the study group were able to use these powder inhalers.

Albuterol↗
PubMed1986

Airflows after inhalation of terbutaline sulphate aerosol from a 750-ml spacer for four weeks.

Terbutaline sulphate was administered to 40 adult asthmatic patients via an ordinary metered-dose inhaler (MDI) or one connected to a 750-ml spacer in an open, randomized, crossover study. Spirometry was obtained before the start of the study and again after four weeks of treatment with each inhaler. The patients recorded on a diary card the severity of their asthma symptoms and the peak expiratory flow rate (PEFR) in the morning before and after drug administration and in the evening. Preinhalation spirometric values were higher after four weeks with the 750-ml spacer than at the start of the study (P less than or equal to 0.05). Daily morning and evening PEFR values were higher after use of the 750-ml spacer than after use of the ordinary MDI (P less than 0.05). Daily symptom scores were generally low. A significantly better effect (P less than or equal to 0.05) with the 750-ml spacer was achieved only in daytime dyspnea. The investigators conclude that the attachment of a 750-ml spacer to an ordinary metered-dose inhaler can improve the efficacy of terbutaline sulphate in the long-term treatment of asthma.

Adult↗
PubMed2000

Comparison of the effect on bronchial hyperresponsiveness of beclomethasone dipropionate administered via a novel multidose dry-powder inhaler or a conventional pressurised metered dose inhaler.

BACKGROUND: Treatment with inhaled corticosteroids improves symptoms and reduces bronchial hyperresponsiveness (BHR) associated with asthma. Delivery of drugs into the lung is dependent on the inhaler device. Furthermore, environmental concerns regarding the use of chlorofluorocarbon propellants in pressurised inhalers and patient acceptability of inhaler devices both influence the extent of use of different delivery systems. OBJECTIVES: To compare the efficacy of beclomethasone dipropionate (BDP) administered via a novel multidose dry-powder inhaler (DPI) and a conventional pressurised metered-dose inhaler (pMDI) with spacer in patients with BHR. METHODS: A randomised, double-blind, crossover study was carried out in a group of 27 patients (aged 19-55 years) with a clinical diagnosis of reversible airway disease, who demonstrated BHR to methacholine (PD(20) < or =6.4 mg). Each patient received BDP (< or =2 mg/day) via the DPI or pMDI, for periods of 4 weeks. The randomised treatment periods were preceded by 3-week washout periods when no corticosteroid was used. Five clinic visits marked the start and end of each study phase. The primary efficacy endpoint was BHR as defined by the pharmacodynamic parameter, PD(20), which was determined at the start and end of each treatment period. Clinical endpoints including lung function, symptoms and adverse events were also evaluated. RESULTS: Both treatments caused a significant decrease in BHR (p<0.05 vs. pre-treatment values). Mean +/- SD changes in log PD(20) were: DPI 0.59+/-1.29; pMDI 0.59+/-0.94 mg. There was no statistically significant difference between treatments and no evidence of a carry-over effect between treatments on BHR. Clinical efficacy and safety parameters also demonstrated no statistically significant treatment differences, and patients found the DPI easier to use. CONCLUSION: Efficacy of BDP in reducing BHR is comparable via the DPI and pMDI plus spacer.

Administration, Inhalation↗
PubMed1990

Spacer-induced atrial fibrillation.

Inhaled sympathomimetics, studied extensively for treatment of asthma, have been found to be safe from cardiac arrhythmias. We discuss a case report of albuterol used with a spacer device that induced atrial fibrillation. We review relevant literature.

Administration, Inhalation↗
PubMed2004

Inhaler technique in older people in the community.

BACKGROUND: Good inhaler technique and medication concordance is important for symptom and disease control in chronic airways disease. OBJECTIVES: Establish the prevalence of inhaler use; the main inhaler devices used by older people at home; their ability to use the inhalers they have been prescribed; and the relationship between perceived ease of use and actual performance. DESIGN: Cross-sectional population based study. SUBJECTS: Subjects aged 70 years and over living at home. METHODS: 500 subjects were randomly selected from 5002 subjects aged 70 years and over living at home. Inhalers used over the previous 24 hours were identified by a nurse on home visit. Those with cognitive impairment were excluded. Inhaler system was assessed and graded by a doctor as acceptable (perfect or minor errors) or unacceptable (major errors), using previously published criteria. Perceived ease of use of the device was rated as easy, moderate or difficult. RESULTS: 423 subjects participated in the study. The population prevalence of inhaler use was 15.8% (12.0, 19.7). Of the 91 inhaler devices used, 39 (42.8%) were metered dose inhalers, 34 (37.4%) were metered dose inhalers with large volume spacers, and 18 (19.8%) were breath-actuated devices. Thirty-two subjects (82.1%) using metered dose inhalers had an acceptable technique compared with 33 (97.1%) of those using metered dose inhalers with large volume spacers and 13 (72.2%) of those using breath-actuated devices (P < 0.05). Up to three quarters of inhalers were considered easy to use but 12% of subjects who rated their inhaler device as being easy to use made major errors. CONCLUSION: Metered dose inhaler was the most frequently prescribed inhaler and was used correctly by most subjects especially in combination with large volume spacers. Major errors were more common with breath-actuated devices. Inhaler technique should be checked as patients' perception of their inhaler skills correlates poorly with actual performance.

Administration, Inhalation↗
PubMed1996

Adrenal suppression with inhaled budesonide and fluticasone propionate given by large volume spacer to asthmatic children.

BACKGROUND: The aim of this study was to compare the systemic bioactivity of inhaled budesonide (B) and fluticasone propionate (F), each given by large volume spacer, on a microgram equivalent basis in asthmatic children. METHODS: Ten stable asthmatic children of mean age 11 years and forced expiratory volume in one second (FEV1) 81.6% predicted, who were receiving treatment with < or = 400 micrograms/day of inhaled corticosteroid, were studied in a placebo controlled single blind (investigator blind) randomised crossover design comparing single doses of inhaled budesonide and fluticasone propionate 400 micrograms, 800 micrograms, and 1250 micrograms. Doses were given at 20.00 hours with mouth rinsing and an overnight 12 hour urine sample was collected for estimation of free cortisol and creatinine excretion. RESULTS: The results of overnight 12 hour urinary cortisol output (nmol/12 hours) showed suppression with all doses of fluticasone propionate (as geometric means): F400 micrograms (11.99), F800 micrograms (6.49), F1250 micrograms (7.00) compared with placebo (24.43), whereas budesonide caused no suppression at any dose. A comparison of the drugs showed that there were differences at 800 micrograms and 1250 micrograms levels for urinary cortisol: B800 micrograms versus F800 micrograms (2.65-fold, 95% CI 1.26 to 5.58), B1250 micrograms versus F1250 micrograms (2.94-fold, 95% CI 1.67 to 5.15). The results for the cortisol/creatinine ratio were similar to that of urinary cortisol, with fluticasone causing suppression at all doses and with differences between the drugs at 800 micrograms and 1250 micrograms. CONCLUSIONS: Single doses of inhaled fluticasone produce greater systemic bioactivity than budesonide when given by large volume spacer on a microgram equivalent basis in asthmatic children. The systemic bioactivity of fluticasone, like budesonide, is due mainly to lung bioavailability.

Administration, Inhalation↗
PubMed2000

[Role of inhalation therapy in respiratory emergencies in children].

Three modes of inhaled therapy are available for the administration of bronchodilators in acute respiratory diseases in children: spacer devices, nebulizers, inhaled powders. Principles, medications available in France, and dosages, are presented. Acute asthma is the main indication.

Acute Disease↗
PubMed2002

Growth problems in children with asthma.

Growth problems are often seen in children with asthma. Rarely, these problems may be caused by poor asthma control. Negatively-deviating growth curves in asthmatic boys aged 8-15 years are often associated with a chronic delay in growth and puberty. Daily treatment with any dose of systemic corticosteroids suppresses the growth rate for as long as the treatment is maintained. The risk of growth rate suppression due to inhaled corticosteroids depends on the dose, administration regimen and delivery device. The risk becomes significant with > or =800 microg budesonide from a metered-dose inhaler with a spacer, and with > or =400 microg budesonide or fluticasone propionate from a dry-powder inhaler. Regardless of the treatment modality applied, all children with asthma should have their height growth measured at least every 6 months, and indications for endocrine work-up should follow general criteria for a growth-insufficient child.

Adolescent↗