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PubMed2000

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 microm 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 (> or = 10 microm) 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.

Aerosol Propellants↗
PubMed2003

Albuterol aerosol delivered via metered-dose inhaler to intubated pediatric models of 3 ages, with 4 spacer designs.

OBJECTIVE: To determine the amount of albuterol, in various particle size ranges, delivered from a hydrofluoroalkane-propelled metered-dose inhaler (Airomir) in 3 models of pediatric intubation (ages 8 months, 4 years, and 16 years) using 4 types of aerosol reservoir: 3 spacers (ACE, AeroChamber HC MV, metal NebuChamber without 1-way valve) and 1 holding chamber (metal NebuChamber with 1-way valve). METHODS: Five reservoirs of each type were tested with albuterol sulfate delivered via metered-dose inhaler that delivers 100 microg of albuterol per actuation. Each reservoir was connected to an endotracheal tube (ETT) that corresponded to the given patient age (8 months = 4 French; 4 years = 5 French; 16 years = 7.5 French) and to a valved system that allowed connection of the ETT to a cascade impactor. Simulated tidal volumes representative of children of the given ages were passed through the reservoir. Both the cascade impactor and the ETT were enclosed within a 100% humidity, 37 degrees C environment. RESULTS: For the total amount of albuterol inhaled onto the impactor, and both the 1.1-4.7 microm and 1.1-3.3 microm inhaled fine-particle fractions, the NebuChamber-with-valve showed significantly greater drug delivery than the NebuChamber-without-valve, the AeroChamber HC MV, or the ACE (p < 0.001). Among the reservoirs without valves the NebuChamber showed significantly greater delivery than the AeroChamber HC MV or ACE (p < 0.001) for total drug deposition and for both the 1.1-4.7 microm and 1.1-3.3 microm fine-particle fractions. These results were consistent over all age groups. The AeroChamber HC MV had significantly greater delivery (total deposition) than the ACE (p < 0.001), except in the 4-year-old model. There were no significant differences between the AeroChamber HC MV and the ACE for either the 1.1-4.7 microm or the 1.1-3.3 microm fine-particle fraction. CONCLUSION: An aerosol reservoir with 1-way valve positioned between the spacer and the ETT improved the amount of inhaled albuterol 300-900%, compared to the other reservoirs.

Administration, Inhalation↗
PubMed2005

Factors guiding the choice of delivery device for inhaled corticosteroids in the long-term management of stable asthma and COPD: focus on budesonide.

Inhaled corticosteroids (ICSs) have become the mainstay of chronic controller therapy to treat airways inflammation in asthma and to reduce exacerbations in chronic obstructive pulmonary disease. An array of ICSs are now available that are aerosolized by a range of delivery systems. Such devices include pressurized (or propellant) metered-dose inhalers (pMDIs), pMDIs plus valved holding chambers or spacers, breath-actuated inhalers, and nebulizers. More recently, dry-powder inhalers (DPIs) were developed to help overcome problems of hand-breath coordination associated with pMDIs. The clinical benefit of ICSs therapy is determined by a complex interplay between the nature and severity of the disease, the type of drug and its formulation, and characteristics of the delivery device together with the patient's ability to use the device correctly. The ICSs budesonide is available by pMDI, DPI, and nebulizer-allowing the physician to select the best device for each individual patient. Indeed, the availability of budesonide in three different delivery systems allows versatility for the prescribing physician and provides continuity of drug therapy for younger patients who may remain on the same ICSs as they mature.

Administration, Inhalation↗
PubMed1994

[Update on inhalation therapy in asthma and obstructive bronchopulmonary diseases].

Significant changes have occurred in aerosol therapy in the last few years. New devices have been developed to facilitate the administration of bronchodilator or anti-inflammatory drugs into the airways. Metered-dose inhaler with or without a spacer or powder devices are now considered the ideal mode of administration of aerosolized medications in the regular treatment of child or adult asthma as well as in COPD. In mild to moderate acute asthma, bronchodilators are ideally administered with a metered dose inhaler with a spacer device, nebulisation being required in only a minority of patients. Powder devices such as the Turbuhaler may also be useful in acute asthma but inspiratory flow should be sufficient, and their usefulness in this context remains to be better determined. In severe acute asthma or in patients unable to properly use the other inhalation devices, nebulisation can be used, with oxygen in the case of acute asthma. In patients requiring mechanical ventilation, administration of bronchodilators can be done with a metered-dose inhaler with a spacer device specifically designed for this purpose: it will replace nebulisation in most cases. In young children and infants unable to use spacer devices with a mouthpiece (< 5 years), wet nebulisation is still used during acute attacks of asthma. In these circumstances, the use of metered-dose inhalers with a spacer and mask are probably appropriate in some children but further studies are required to recommend their use.

Adult↗
PubMed1993

Therapeutic aerosol: principles and practices.

Delivering a drug direct to the site of disease has several advantages. In the case of aerosols, it only requires about one-twentieth of the oral dose of the drug to exert its effect, thus resulting in less or minimal systemic side-effects. The onset of action is fast and the efficacy is superior to the oral drug. Because of the anatomy of the airways which are protective against the inhalation of foreign substances, the aerosol particles must be inhaled in an optimal way in order to reach the sites of action which are the peripheral airways. The particle size must be small and the aerosol must be inhaled in a coordinated manner, especially when a pressurised metered dose inhaler is used. Because of the high pressure of the propellants used in the canister, the particles will travel at a rapid speed upon actuating, causing great impaction in the throat. Only a small percentage reaches the peripheral airways and this percentage is even smaller if the coordination between actuation and inhalation is poor. Spacers have been shown to be able to overcome this problem of incoordination and to reduce throat impaction. Alternatively, the breath-actuated dry powder inhaler can be effectively used. The nebuliser, which is another aerosol delivery system, needs proper setting of the flow rate of compressed air and an appropriate volume of solution in order to optimise the drug delivery.

Aerosols↗
PubMed2003

Majority of children aged 3 years and above can reliably inhale through the Clickhaler.

Guidelines suggest that pressurized metered dose inhalers (pMDI) plus spacers are the delivery system of choice for children. However, they are bulky, which makes them inconvenient. It was suggested that the smaller dry-powder inhalers (DPIs) may be suitable for delivering short-acting bronchodilators to preschool children. This study considered whether preschool children could reliably generate sufficient inspiratory flows to use the Clickhaler DPI. Twenty-seven asthmatic and 34 nonasthmatic children, aged 2-5 years, were recruited. Following training, they were asked to inhale four times through a Clickhaler flow monitoring system, twice "steadily" and twice "forcefully." Inspiratory flow data were collected during each inhalation. Of the 3-, 4-, and 5-year-old asthmatics, 62.5, 100, and 100%, respectively, could reliably differentiate between inhaling and exhaling through the DPI. For nonasthmatics, the figures were 66, 60, and 88%, respectively. All but one of the children who understood the instructions generated a PIF of greater than 15 l/min (range, 13.9-88.3 l/min and 21.2-84.5 l/min in asthmatic and nonasthmatic children, respectively). These data indicate that the majority of children aged 3 years and above could reliably inhale rather than exhale through a dry-powder inhaler, and that they generate inspiratory flows sufficient to use the Clickhaler effectively. The results indicate that the device could be a suitable delivery system for beta(2)-agonists in preschool children.

Administration, Inhalation↗
PubMed1990

Treatment of acute, episodic asthma in preschool children using intermittent high dose inhaled steroids at home.

In a double blind, controlled trial, the effect of high dose beclomethasone dipropionate (750 micrograms three times daily for five days) administered by metered dose inhaler and valved spacer, was compared with placebo, during 70 paired episodes of acute asthma in 24 preschool children. Treatment commenced at home at the first sign of an attack. Parents' blind preference for active treatment was significant. Data from 17 pairs of treatment, however, were affected by interventions such as hospital admission or oral corticosteroid treatment. These events occurred similarly in active and control periods. An intrasubject comparison was made of diary scores from the 18 pairs of episodes in which no intervention occurred in either the active or placebo treatment. Both daytime and night symptoms over the first week of the attack were significantly reduced by active treatment. Intermittent high dose inhaled beclomethasone dipropionate is beneficial in modifying the severity of acute episodic asthma in preschool children able to use a spacer device.

Acute Disease↗
PubMed1995

High-dose MDI salbutamol treatment of asthma in the ED.

Beta-adrenergics have long been under special scrutiny because of their potential for cardiotoxicity. To assess the safety of high doses of salbutamol delivered by metered dose inhaler (MDI) with spacer in the emergency department (ED) setting, 11 patients (mean age 33 +/- 12.2 years) with severe acute asthma were studied. All patients were treated with 400 micrograms of salbutamol at 10-minute intervals for 3 hours (1,200 micrograms each 30 minutes or 7,200 micrograms at 180 minutes. There were dose-related significant increases in forced expiratory volume in the first second (FEV1) and peak expiratory flow (PEF) (P < .01), with a net mean increase of 90.4% and 80.1%, respectively. A significant (P < .01) reduction of heart rate was observed with treatment. At the end of protocol, reductions ranged from 7 beats/min to 35 beats/min (mean decrease 10.6 +/- 10.5 beats/min). There was no prolongation in the QTc interval. Mean baseline serum potassium was 4.23 +/- 0.53 mmol/L and decreased nonsignificantly after treatment to 3.99 +/- 0.62 mmol/L. Only 4 patients showed net decreases. There were no significant changes in oxygen saturation and plasma glucose. The mean end-treatment salbutamol level was 10.0 +/- 1.67 ng/mL. These data support the notion that treatment of acute asthma patients in the ED with 2.4 mg salbutamol per hour delivered by MDI and spacer produce satisfactory bronchodilation, low serum concentration, and minimal extrapulmonary effects.

Acute Disease↗
PubMed1997

Competence thresholds for the use of inhalers in people with dementia.

METHODS: the ability to learn three inhaler techniques of increasing levels of complexity was studied in 50 normal and demented inhaler-naive elderly people (mean age 81 years) with stable 10-point mini-mental test scores (MTS). There were 10 subjects in each of the following groups: MTS 8-10 (non-demented), MTS 7 (borderline), MTS 6 (mild dementia), MTS 5 and MTS 4 (2 moderate dementia groups). The techniques were taught on one day and reassessed on the following day on consecutive days in ascending order of complexity. RESULTS: those with an MTS of 4 were unable to learn any of the techniques, while all the non-demented people could learn all three techniques. For the five-stage technique (standard metered dose inhaler) the 0% threshold (i.e. when none of the subjects was able to learn) was MTS 6, the 50% threshold (at least half but not all could learn) MTS 7 and the 100% threshold (all could learn) MTS 8. For the four-stage technique (inhaler with large spacer) the 0% threshold was MTS 5, the 50% threshold MTS 6 and the 100% threshold MTS 8. For the three-stage technique (inspiration-triggered inhaler) the 0% threshold was MTS 4, the 50% threshold MTS 5 and the 100% threshold MTS 7. CONCLUSIONS: MTS can be used to determine the likelihood of a mild or moderately demented patient being able to learn a multiple-stage inhaler technique.

Aged↗
PubMed2000

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 microgram 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.

Administration, Inhalation↗
PubMed1999

The technology of metered-dose inhalers and treatment costs in asthma: a retrospective study of breath actuation versus traditional press-and-breathe inhalers.

This paper reviews the impact of the use of technologically dissimilar beta-agonist aerosols--the Maxair Autohaler (pirbuterol acetate) breath-actuated aerosol and the traditional albuterol press-and-breathe inhaler-on the treatment costs of asthma. If, as clinical evidence would suggest, the breath-actuated aerosol is not only as effective as an albuterol inhaler with a spacer, but is easier to use and results in more optimal beta-agonist use by patients, then one might consider the hypothesis that patients possessing a breath-actuated inhaler would, ceteris paribus, experience lower asthma-related treatment costs-principally, those medical costs associated with fewer emergency room visits and hospitalizations. This hypothesis is considered from the perspective of a retrospective claims database study of patients who used one or the other beta-agonist inhaler exclusively. At the descriptive level, costs of treatment for patients using the press-and-breathe inhaler are estimated to be 16.5% greater than costs for patients using the breath-actuated inhaler. In the multivariate analysis, the presence of the breath-actuated inhaler (in a dummy variable analysis) was not only statistically significant (P < 0.05), but entered with the expected negative sign. Estimated cost impacts under various model specifications are consistent with the magnitude of the cost differences reported in the descriptive analysis. Total cost savings with the Maxair Autohaler ranged from 8.7% to 11.7%, with medical cost savings estimated at 14.6%.

Adrenergic beta-Agonists↗
PubMed2002

Role of budesonide inhalation suspension in children with asthma.

OBJECTIVE: To evaluate the role of budesonide inhalation suspension (BIS) in the treatment of children with asthma. DATA SOURCES: Literature identified through Medline (1966-November 2000) and references obtained from selected articles. Search terms included budesonide and asthma. DATA SYNTHESIS: Asthma is a chronic inflammatory disease that affects approximately 4.8 million children in the US. By reducing inflammation, corticosteroids decrease symptoms and improve lung function. As the first nebulized corticosteroid, BIS offers an important treatment option for children with persistent asthma. CONCLUSIONS: BIS is effective in reducing symptoms and improving lung function in children with asthma. It should be used in children ages 1-8 years with moderate to severe persistent asthma who are unable to effectively use a metered-dose inhaler with or without a spacer or a dry-powder inhaler.

Administration, Inhalation↗
PubMed2004

Bacterial contamination of inhalation chambers: results of a pilot study.

Spacers are used in the treatment of children with asthma. It is advised to clean the spacers regularly. However, cleaning can influence drug delivery. One obvious reason to clean a spacer is prevention of bacterial contamination. Whether spacers are contaminated or not is unknown. We cultured spacers, brought in by children with asthma or recurrent wheeze who visited our outpatient clinic during a 4-month period. The spacers of 64 children were studied, and 24 (38%) were contaminated; most often (13 cases), Bacillus species were found. Only one spacer grew a potential pathogenic bacterium (Pseudomonas aeruginosa). No correlation with type of inhaler, duration of usage, drug, or visual aspect was found. Spacers, cleaned according to national guidelines, were not less contaminated. Bacterial contamination of spacers is frequent, but the bacteria cultured are not pathogenic. Intensive cleaning of spacers does not influence the level of contamination with environmental bacteria.

Asthma↗
PubMed1990

Inhalation delivery of asthma drugs.

In the immediate future, metered-dose inhalers (MDIs) with spacers remain the aerosol application of choice for topical steroids, mainly to reduce side effects. For beta 2-agonist, anticholinergics and prophylactic drugs, MDI (with or without demand valve), dry powder inhalers (multidose inhalers), ultrasonic or jet aerosol generators (with or without mechanical breathing assistance [IPPB]) are chosen according to the preference or the ability of the patients to perform the necessary breathing maneuvers as well as the availability of different products in different countries.

Adrenal Cortex Hormones↗
PubMed1985

Once daily inhalation of budesonide in the treatment of chronic asthma: a clinical comparison.

In a short-term, open cross-over clinical efficacy study, inhalation of budesonide 800 micrograms once daily was compared to inhalation of budesonide 400 micrograms twice daily and beclomethasone dipropionate 200 micrograms four times daily in 20 patients with stable steroid-dependent chronic asthma. Budesonide was inhaled through a spacer tube. The drugs were given in 3-week periods. Clinical symptoms, consumption of beta 2-agonists and peak flow were measured. In all but one patient, the reduced frequency of budesonide inhalations to only once daily has not given significantly different results compared with more frequent inhalations.

Administration, Intranasal↗
PubMedDate not supplied

Bronchodilator effect of fenoterol and ipratropium bromide in infants with acute wheezing: use of MDI with a spacer device.

Twenty-eight infants admitted to Exequiel González Cortes Children's Hospital because of acute wheezing (AW) were randomly assigned to three study groups. Fenoterol (FNT), ipratropium bromide (IB), and placebo were administered respectively to children in the different groups by means of metered dose inhalers (MDI) with spacers, using doses of 3 puffs every hour, for 4 hours. The degree of bronchial obstruction was assessed clinically and scored with the single-blind method every hour prior to each treatment. The criterion of a bronchodilator effect was a significant decrease in the degree of bronchial obstruction at subsequent scorings. The scores of the three groups were compared using the Student's t test for matched samples. The same test was also applied to the independent samples for determining the superiority of one treatment, FNT or IB, over the other. The results indicated a significant decrease in the scores of the groups receiving FNT and IB (P less than 0.05); this did not occur in the group in which placebo was used. FNT produced a more rapid and sustained effect than IB (P less than 0.05). Significant bronchodilator effect was obtained in infants with AW when repeated doses of FNT or IB were administered with MDI and spacers. This effect was significantly greater in the group treated with FNT.

Acute Disease↗
PubMed1989

High-dose inhaled steroid therapy for asthma.

Only a small minority of patients with asthma have symptoms severe enough to require high-dose inhaled steroid therapy. Because they need more aggressive treatment, this group is disproportionately represented in tertiary care referral centers. Therapeutic effects are dose dependent, and the daily dose of steroid required to normalize pulmonary function far exceeds that for symptom relief. Studies show that, if titrated to minimum dose levels of each the combination of inhaled and oral steroids provides a better balance between antiasthmatic and systemic glucocorticoid activity compared with oral steroid alone. Also, rapidly metabolized inhaled steroids such as budesonide may be associated with a lower risk for the osteoporotic complications seen with long-term oral steroid use. However, high dose of inhaled steroids may lead to adrenocortical suppression and hence estrogen deficiency in postmenopausal women. Morning dosing may mitigate this effect. Oropharyngeal thrush may be prevented by lowering the dose frequency or using a spacer. During prolonged inhaled steroid therapy, patient compliance has proved an important determinant of outcome.

Administration, Inhalation↗
PubMed2000

Efficacy of salbutamol via Easyhaler unaffected by low inspiratory flow.

The fine particle dose delivered via dry powder inhalers (DPIs) is often affected by the inspiratory flow rate generated during inhalation. This has clinical implications, since the fine particle dose determines the amount of drug reaching the lungs. With Easyhaler DPI the fine particle dose remains relatively constant over the range of inspiratory flow rates from 30-60 l min(-1). The aim of this study was to confirm that clinical efficacy is maintained even at low flow rates by comparing the bronchodilating effect of salbutamol (100 microg) delivered via Easyhaler at a target inspiratory flow of 30 l min(-1) with the same dose of salbutamol via pressurised metered-dose inhaler (pMDI) plus spacer. This was a double-blind, randomized, cross-over study with double-dummy technique. Twenty-one paediatric and adult asthmatic patients completed the study, which was conducted over 2 study days. The main outcome parameter was forced expiratory volume in 1 sec (FEV1). The patients were trained to generate a low peak inspiratory flow rate (PIFR) of 30 l min(-1), and the actual PIFR through Easyhaler was recorded. The average PIFR through Easyhaler was 28.7 l min(-1). The difference in the maximum value of FEV1 (FEV1max) between the treatments after drug inhalation was 0.01 l. The mean of FEV1max was 2.67 l after pMDI plus spacer compared to 2.69 l after Easyhaler. Improvements in FEV1 were clinically significant. No significant differences between treatments were found. A reasonably low inspiratory flow rate through Easyhaler produces an equivalent improvement in lung function to a correctly used pMDI plus spacer. Hence, Easyhaler can be used with confidence in patients who may have difficulty in generating a high inspiratory flow rate, such as children and the elderly.

Adolescent↗