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At least 127 records · Page 7Linked to original sources
PubMed1994

Treatment of acute asthma. Lack of therapeutic benefit and increase of the toxicity from aminophylline given in addition to high doses of salbutamol delivered by metered-dose inhaler with a spacer.

We conducted a randomized, double-blind, placebo-controlled study to determine if intravenous aminophylline adds any benefit to high doses of inhaled salbutamol in patients who presented for treatment of acute asthma. We studied 94 patients (mean age, 35.6 +/- 11.2 years) with moderate to severe acute asthma. All patients received therapy with salbutamol delivered with metered-dose inhaler (MDI) into a spacer device (Volumatic) in four puffs (400 micrograms) at 10-min interval, and intravenous hydrocortisone (500 mg). Patients were randomly assigned to receive either a loading dose of intravenous aminophylline followed by a routine infusion (n = 45) or an equal volume of placebo as a loading dose and infusion (n = 49). The two groups showed no differences in measurements of peak expiratory flow, FEV1, and FVC at baseline and at the end of treatment. However, the patients treated with aminophylline had significantly more adverse effects (p < 0.05). There were no differences in the final mean dose of salbutamol (6.3 +/- 44.5 mg for the placebo group and 5.8 +/- 4.2 mg for the aminophylline group), hospital admission rate (10.2 percent for the placebo group and 9.0 percent for the aminophylline group), and mean duration of Emergency Department treatment (2.5 +/- 1.83 h for the placebo group and 2.37 +/- 1.75 h for the aminophylline group). The results were similar when the patients were divided in accord with the degree of respiratory obstruction (baseline FEV1 < 30 percent of predicted) and theophylline level at 30 min of treatment (placebo group patients with theophylline level < 10 mg/L vs aminophylline group patients with theophylline level > or = 10 mg/L). We conclude that intravenous aminophylline adds to the toxicity but not the efficacy of inhaled salbutamol in the treatment of acute exacerbations of asthma.

Acute Disease↗
PubMed1995

In vitro properties of pressurized metered dose inhalers with and without spacer devices.

Pressurized metered dose inhalers (pMDIs) have been used for the administration of drugs to patients with asthma since the late 1950s. However, it is only during the last few years that attention has been paid to how they work in detail. Studies have shown that the first dose, after the inhaler has been at rest for some hours, can be very variable. For suspension formulations, shaking the inhaler before actuation is important, since omitting shaking will affect the dose uniformity. The addition of a spacer device may increase the variability of the available dose. Factors affecting the available dose are, the electrostatic charge on the walls of the spacer device, the volume of the spacer device and the choice of material for the spacer device. Moreover, the fine particle dose, a measure of the effective deposition of inhaled drug in the airways, has been shown to be greater with a pMDI and a spacer device in comparison with a pMDI alone and is dependent on the choice of impactor inlet.

Administration, Inhalation↗
PubMed2000

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.

UNLABELLED: 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. OBJECTIVE: To demonstrate clinical equivalence between a spacer device and a nebulizer for albuterol administration. DESIGN: Randomized, double-blind, parallel group equivalence trial. SETTING: Pediatric emergency wards at 2 tertiary teaching hospitals. PATIENTS: Sixty-four 12- to 60-month-old children with acute recurrent wheezing (32 per group). INTERVENTIONS: 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. OUTCOME MEASURES: Pulmonary index, hospitalization, ease of use, acceptability, and pulse oximetry saturation. RESULTS: 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%). CONCLUSIONS: 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.

Acute Disease↗
PubMed2000

No objective benefit from steroids inhaled via a spacer in infants recovering from bronchiolitis.

A double-blind randomized placebo-controlled trial was conducted to investigate the efficacy of 3 months' inhaled steroids delivered via a spacer device with face mask attachment to infants recovering from bronchiolitis. Forty-eight previously healthy infants recovering from their first documented episode of acute bronchiolitis were randomized to receive 150 microg fluticasone propionate (FP) b.i.d. or placebo delivered via the Babyhaler spacer. Longitudinal assessments were performed on seven occasions over 1 yr based on symptom diaries and health records, clinical examinations, overnight cough recordings and oxygen saturation readings. Lung function was measured 6 months after hospital discharge. Forty-three infants completed the trial (FP 21, placebo 22). There were no significant differences in the three objective end-points measured, recorded night cough, oxygen saturation and lung function test results. Symptom scores were low in both the FP and placebo groups with the absence of (0) or mild (1) symptoms > or =90% of the trial days. No statistical differences in symptom frequency, use of rescue respiratory medications or hospital admissions between treatment groups were found throughout the trial or follow-up periods. In conclusion, the use of inhaled fluticasone propionate in infants recovering from acute bronchiolitis cannot be recommended.

Administration, Inhalation↗
PubMed2003

Comparative efficacy of terbutaline sulphate delivered by Turbuhaler dry powder inhaler or pressurised metered dose inhaler with Nebuhaler spacer in children during an acute asthmatic episode.

AIMS: To compare the efficacy of terbutaline sulphate delivered via Turbuhaler with a pressurised metered dose inhaler (pMDI) connected to Nebuhaler spacer in a population of asthmatic children presenting to emergency departments because of an acute episode of asthma. METHODS: Randomised double blind, double dummy, parallel study of acute asthma in the emergency department. A total of 112 children (6-16 years), who had a diagnosis of asthma, a baseline FEV1 of 25-60% of predicted normal value (PNV), and the ability to perform spirometry were studied. Patients received two doses of 0.5 mg/10 kg (maximum 2.0 mg) of terbutaline sulphate at time 0 minutes and time 30 minutes. The two groups were also stratified into subgroups based on FEV1: 25-45% and 45.1-60% PNV. FEV1 before treatment and at two 15-minute intervals after each treatment was the main outcome measure. PIF, PEF, heart rate, SpO2, and tremor were also measured at these times. RESULTS: Both the Turbuhaler and pMDI+Nebuhaler groups showed significant increases from baseline to final value in their FEV1 results, 49% and 50% change from baseline to t = 60 min, respectively (p < 0.001) using last value carried forward. No significant difference was found between the two groups for these results. Subanalysis of the stratified groups revealed similar results. In addition, no significant difference was found in the group and subgroup comparisons for heart rate, SpO2, and tremor. CONCLUSION: Results show that Turbuhaler and pMDI+Nebuhaler are similar in terms of benefit and side effects in the treatment of acute moderate to severe asthma attacks in this study population.

Acute Disease↗
PubMed2001

Cost-effectiveness of fluticasone propionate administered via metered-dose inhaler plus babyhaler spacer in the treatment of asthma in preschool-aged children.

STUDY OBJECTIVES: To evaluate the cost-effectiveness of inhaled fluticasone propionate (FP) in children aged 12 to 47 months with asthma symptoms. DESIGN: A retrospective economic analysis conducted from the perspective of the Danish health-care system, based on clinical data from a 12-week study. SETTING: Thirty-three outpatient centers in nine countries. PATIENTS: Two hundred thirty-seven children aged 12 to 47 months with documented history of recurrent wheeze or asthma symptoms. INTERVENTIONS: Two dosages of FP, 100 microg/d and 200 microg/d, and placebo administered in two divided doses via a metered-dose inhaler and a Babyhaler (Glaxo Wellcome; Middlesex, UK) spacer device. MEASUREMENTS: Effectiveness in terms of asthma exacerbations, control of cough and wheeze symptoms, symptom-free days, overall direct costs of asthma management in Danish kroner at 1999 prices, and mean and incremental cost-effectiveness ratios. RESULTS: FP, 200 microg/d, was significantly more effective than placebo treatment in terms of the proportion of exacerbation-free patients (73.7% vs 59.8%; p = 0.025) and patients experiencing a > or = 25% improvement in cough symptoms (57.9% vs 39.0%; p = 0.018). The costs per exacerbation-free patient, per patient with a > or = 25% improvement in cough and wheeze symptoms from baseline, and per symptom-free day were lower in the FP groups than in the placebo group. The incremental cost-effectiveness ratios for these end points indicated that the additional benefits of FP, 200 microg/d, were achieved at a lower overall cost compared with placebo treatment. CONCLUSIONS: From the perspective of the Danish health-care system, FP, 100 microg bid, administered via the Babyhaler inhalation device was cost-effective relative to standard therapy with bronchodilators alone.

Androstadienes↗
PubMed2001

Influence of respiratory spacer devices on aerodynamic particle size distribution and fine particle mass of beclomethasone from metered-dose inhalers.

Respiratory spacer devices are used mainly with pressurized metered dose inhalers, especially those containing corticosteroids, to assist with patient coordination and reduce oropharyngeal side effects. This investigation examines the influence of different spacer devices on the delivered fine particle mass (aerodynamic diameter of <3.3 microm and <4.7 microm) of the corticosteroid beclomethasone dipropionate, which approximates the respirable dose. The Anderson Mark II Cascade Impactor was used to characterise the deposition of single doses of beclomethasone dipropionate from several metered-dose inhalers. Following actuation of one single dose the amount of beclomethasone dipropionate deposited on each stage of the impactor was quantified using reverse phase high-performance liquid chromatography and ultraviolet detection. The fine particle mass smaller than 4.7 microm for Respocort delivered by the Sanner and Fisonair spacer devices was 77.7% and 41.3% higher (p < 0.04), respectively, than the metered-dose inhaler alone, while the Breathatech spacer delivered 21.4% lower (p < 0.01). The fine particle mass of Becotide delivered by the Sanner, Fisonair, Nebuhaler, and Volumatic spacer devices were 81%, 42.4%, 46.9%, and 32.8% higher (p < 0.008), respectively, than be metered dose inhaler alone. The fine particle mass for Becloforte delivered by the Sanner, Fisonair, and Volumatic spacer devices was 82.8%, 36.9%, and 48.0% higher (p < 0.009) than that delivered by metered dose inhaler alone. This study suggests that there are significant differences in the fine particle mass of beclomethasone dipropionate delivered by respiratory spacer devices when used in conjunction with commercially available metered dose inhalers of this drug.

Aerosols↗
PubMed1997

The Spacehaler for delivery of salbutamol: a comparison with the standard metered-dose inhaler plus Volumatic spacer device.

The Spacehaler is a new, compact, pressurized aerosol device that uses the same canister as a conventional metered-dose inhaler (MDI). Its design, however, reduces the velocity of the aerosol cloud that emerges from the inhaler, thereby reducing the amount of the non-respirable fraction of the drug delivered to the patient. Large volume spacers achieve a similar effect, but they are bulky and therefore inconvenient to use and carry around. This study compared the bronchodilator effect of 200 micrograms salbutamol delivered by the Spacehaler to that of an MDI used with a Volumatic spacer (MDI plus spacer) in patients with reversible obstructive airways disease. Twenty-five patients with asthma, having a forced expiratory volume in 1 s (FEV1) between 50 and 90% predicted and a reversibility of > or = 15% to 200 micrograms salbutamol given by the conventional (standard) MDI entered the study. On two separate study days, they inhaled 200 micrograms salbutamol either via the Spacehaler or the MDI plus spacer. To maintain blinding, they received placebo on both study days via the alternate device. Their FEV1, forced vital capacity (FVC) and peak expiratory flow (PEF) were measured before and at regular intervals for 6 h after inhalation. Assessment of equivalence between the two devices was based on whether the 90% confidence interval for the difference between the weighted mean FEV1 was within +/- 0.25 1. Patient preference was assessed by a questionnaire at the end of the second study day. Twenty-four patients completed the study. Both devices produced a significant improvement in FEV1 (P < 0.02). The upper and lower 90% confidence limits for the difference in weighted mean FEV1 between the devices was +/- 0.041, and the 99% confidence limits were +0.061 and -0.071. The weighted means for FVC and PEF, and the duration of effect and peak responses for FEV1, FVC and PEF also showed no difference between the two devices. Patients found no difficulty in using the Spacehaler, and 20 out of 24 patients (83.3%) preferred it to the MDI plus spacer. The bronchodilator effect of 200 micrograms salbutamol administered by a Spacehaler was equivalent to that produced by an MDI plus spacer in this group of patients with reversible airways obstruction. The majority of patients preferred it to a large volume spacer.

Adult↗
PubMed1998

Metered-dose inhaler add-on devices: an in vitro evaluation of the BronchoAir inhaler and several spacer devices.

Spacer devices minimize the drug deposition in the oropharyngeal region as they retain between 30% and 50% of the nominal drug dose. Additionally, they should increase the fine particle fraction of the emitted aerosol. A new effort to increase the lung deposition was the design of a new actuator, the BronchoAir inhaler, (BronchoAir Medizintechnik GmbH, Munich, Germany). This study was carried out to evaluate the usefulness of this new actuator device by comparing its fine particle fraction with that emitted with the standard actuators and with spacer devices. The fine particle fraction's of commercially available metered dose inhalers (MDIs) marketed with specific spacers were determined using a multistage liquid impinger (MSLI). The effect of the BronchoAir inhaler on fine particle fractions was quite dependent on the formulation causing a decrease as great as 43% with Beclomet forte (beclomethasone-17, 21-dipropionate [BDP]) and an increase as great as 35% with Arubendol (salbutamol) but causing a difference of less than 20% with the other six tested formulations. Deposition in the upper stages of the impinger was sometimes higher than it was for the standard actuator. Spacer devices decreased the deposition in the upper stages of the impinger significantly, and in some cases, the fine particle fractions were also decreased. Varying the spacer design showed the superiority of large-volume open spacers compared with spacers with other designs.

Bronchodilator Agents↗
PubMed1994

Inhalation anti-asthma therapy with spacers: technical aspects.

Inhalation is the method of choice for delivering therapeutic agents to the lung. The advent of metered-dose inhalers (MDIs) has made inhalation easier, less expensive and more efficient. However, 20-50% of patients are unable to use MDIs correctly. The main problems are: 1) impact of aerosol particles in the mouth (responsible for side-effects); 2) poor co-ordination between firing the MDI and breathing; 3) and too fast an inspiration. Various spacer devices have been designed to overcome these problems. These are: large volume devices, which reduce the oral impact and select the respirable particles; devices equipped with a one-way valve that reduces co-ordination problems; indication of too rapid an inspiration by a high-flow mark. The introduction of these devices has resulted in an improved bronchial/oral deposition rate and a reduced incidence of side-effects. Training and education of patients is fundamental in ensuring the correct use of inhalers.

Adult↗
PubMed2005

Assessment of use of spacer devices for inhaled drug delivery to asthmatic children.

In the treatment of bronchial asthma, inhaled therapy with both bronchodilators and corticosteroids represents the basis for acute and long-term management. Drug therapy in asthma is predominantly by pressurized metered dose inhalers. The impact of treatment on the disease morbidity and mortality depends to a large extent on appropriate delivery of drug to the lungs by means of a spacer device. We performed an audit on spacer use in 200 children and showed that 99% owned a spacer, 2% owned but did not use their spacer, 11% were using a spacer which was not ideal for their age, 17% had a poor technique, and 24% were not following the recommendations given on previous visits to wash the spacer only with a soapy solution. Although physicians frequently associate poor control of asthma with inadequate doses of drugs, many factors must be considered before increasing the dose of inhaled medications to children. We should all ensure that the drugs we prescribe are delivered in the best possible manner, thus improving control of asthma, reducing side effects and offering a more cost-effective therapy.

Administration, Inhalation↗
PubMed1997

[Acute asthma in children; guidelines by pediatric pulmonologists for diagnosis and treatment].

The diagnostic phase in a child with acute asthma should be short and comprise a brief history-taking, inspection and auscultation of the thorax, transcutaneous oxygen measurement and, if possible, peak flow measurement. Blood picture. sputum culture and chest X-ray may be included in the diagnostics if indicated. The primary treatment consists of administration of bronchodilators (beta-2 sympathicomimetics) by inhalation, using a spacer. Repeated inhalation of salbutamol and ipratropium may be necessary. In case of inadequate improvement (spraying necessary every 3 hours for 24-48 hours), hospitalization and systemic administration of corticosteroids are indicated. Other reasons for hospitalization are a transcutaneous oxygen saturation lower than 91%, complications such as subcutaneous emphysema and pneumothorax, exhaustion of child or parents, and rapid aggravation of the clinical picture with rising Pco2 and falling pH in capillary or arterial blood.

Acute Disease↗