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PubMed1998

[Inhalation of sodium cromoglycate through a spacer device: no effect on symptoms in preschool children with moderate asthma].

Recently a randomised placebo controlled trial in a general practice setting showed that inhaler therapy with a spacer device in 218 1-4 year old children with moderate asthma is feasible, but that treatment with cromoglycate was no more effective than placebo. The lack of benefit from the treatment with cromoglycate may have resulted from several points discussed and refuted in this commentary. Major points are the degree of asthma of the children and uncertainty about the amount of medication that reached the lungs. The results of the trial support the intentions of national and international guidelines to withdraw the recommendation of cromoglycate as the first choice in prophylactic asthma treatment.

Administration, Inhalation↗
PubMed1990

Effect of the new spacer-device on the deposition of the inhaled metered dose aerosol.

The effect of the new spacer-device on the in vitro and in vivo deposition of inhaled drug particles was studied. The in vitro deposition of beclomethasone dipropionate 250 micrograms/dose aerosol administered either through the conventional aerosol actuator with the short plastic mouthpiece or through the new pear-shaped spacer-device was evaluated with the modified cascade impactor method. For the in vivo study the disodium cromoglycate particles were labelled with a pure gamma-radiator 99mTc using a coprecipitation technique based on spray drying. The deposition of the inhaled disodium cromoglycate particles in the human respiratory tract after administration of the drug doses from the devices tested was determined by means of a gamma camera. The new spacer-device increased both in the in vitro and in vivo tests the fraction of the drug dose deposited into the therapeutically significant regions of the respiratory tract. In addition, the therapeutically insignificant fraction deposited in the upper airways and mouth clearly decreased. Thus using the new spacer-device evaluated in this study the local side effects would be decreased.

Aerosols↗
PubMed2004

Comparison of efficiency and preference of metal and plastic spacers in preschool children.

BACKGROUND: The metal NebuChamber valved holding chamber (VHC) has gained wide acceptance among children with asthma. Due to its nonelectrostatic properties and larger volume, the 250-mL, metal NebuChamber delivers a greater mass of aerosol to a filter at the mouth compared with the commonly used 150-mL polypropylene AeroChamber VHC. Such in vitro results have been used to suggest that this may provide increased efficacy with the NebuChamber. No comparative efficacy data exist for preschool children with asthma. OBJECTIVE: To compare efficiency and preference of metal and plastic spacers in preschool children. METHODS: Children with mild-to-moderate persistent asthma received 200 microg of budesonide twice daily by NebuChamber or AeroChamber, both with the mask provided in a randomized, 2-month, crossover trial. Symptom diary cards, beta-agonist use, and preference by children and parents were compared. RESULTS: Thirty children (mean +/- SD age, 4.3 +/- 0.3 years) completed the study. There was no difference between the AeroChamber and NebuChamber in clinical efficacy outcomes. There was no difference between the AeroChamber and NebuChamber in parents' view of ease of use, design, acceptability by the children, and overall satisfaction. CONCLUSIONS: Despite a greater total dose delivered to the mouth, the NebuChamber appears no more effective than the AeroChamber and it is not preferred by patients or parents. More parents chose to continue to use the NebuChamber after the study.

Administration, Inhalation↗
PubMedDate not supplied

Reassessment of the role of theophylline in the current therapy for nocturnal asthma.

BACKGROUND: Symptoms of asthma commonly increase at night for a variety of reasons. While different options are available for the management of nocturnal asthma, theophylline has maintained a prominent role in treating this problem, and it is widely promoted as a first-line agent. Very recent reports stress the use of anti-inflammatory agents as the drugs of choice for the long-term treatment of asthma. METHODS: Using the key words "asthma," "theophylline," "bronchodilators," "adrenal cortex hormones," "beclomethasone," "triamcinolone acetonide," and "disodium cromoglycate," the MEDLINE files were searched from 1982 to the present. Articles dating before 1982 were accessed from cross-reference of the more recent articles. RESULTS: Sustained-release theophylline preparations are effective in decreasing the rate of exacerbations of nocturnal asthma symptoms, but theophylline has risks of major toxicity and serum concentrations must be monitored. Inhaled corticosteroids are also useful in controlling nocturnal asthma, and they reduce inflammation, which is the basic problem in asthmatics. Inhaled anticholinergics and oral controlled-release albuterol are also helpful in reducing symptoms of nocturnal asthma. CONCLUSIONS: A suggested approach to managing nocturnal asthma includes corticosteroids inhaled through a spacer device at optimum doses, adding inhaled albuterol or oral sustained-release albuterol and then ipratropium with a spacer. If control is not maintained with this regimen, sustained-release theophylline may add benefit to inhaled steroid therapy in reducing nighttime asthma symptoms. Long-acting inhaled beta 2 agonists show promise and could be the adjunctive treatment of choice when they become available in the United States.

Adrenal Cortex Hormones↗
PubMed2004

The influence of formulation and spacer device on the in vitro performance of solution chlorofluorocarbon-free propellant-driven metered dose inhalers.

The purpose of this study was to evaluate the hypothesis that spacer devices have limited effect on the in vitro fine particle dose emitted from solution metered dose inhalers containing different proportions of HFA134a [1,1,1,2,-tetrafluoroethane] propellant. Two solution formulations (80% and 97.5% wt/wt HFA134a) were tested across the actuator alone, actuator plus Aerochamber, and Ace holding chamber. Particle size distributions were determined using laser diffraction (LD) and cascade impaction (CI). Multimodal particle size distributions were identified using LD. CI analyses were characterized by a major mode located at approximately 0.5 microm. The fine particle dose emitted from the inhaler spacer combinations containing 97.5% HFA134a was independent of the device setup used. Fine particle doses were influenced by spacer setup in 80% HFA134a formulations, indicating different plume dynamics of low vapor pressure formulations. Sampling inlet deposition was approximately 0 when spacer devices were used with either formulation. When spacers were not used, sampling inlet deposition was increased significantly. However, inlet deposition with the 97.5% HFA134a formulation was significantly less than that of the 80% HFA134a formulation (approximately 25% of emitted dose compared with 69%, respectively). Thus, high propellant concentration formulations appear to have more robust in vitro performance. This is particularly important given the preponderance of poor patient compliance that is associated with spacer use. High propellant concentrations had the advantage of fine particle doses that were independent of the device setup and significantly lowered sampling inlet deposition when no spacer was used.

Aerosol Propellants↗
PubMed2001

Guidelines for devices and choices.

Asthma patients can be treated safely and effectively with the compounds and inhalation devices currently available. However, the choice of devices is so wide that the healthcare professional may be easily confused, and the effectiveness of treatment reduced. Clear guidelines are needed to help resolve this difficulty; however, those currently available do not contain enough useful information on the different delivery systems to assist the selection process. The function of the anti-asthma drug (i.e., preventer or reliever) should determine the choice of device. For inhaled corticosteroids, the device should provide effective and reliable delivery, while simplicity in use will aid good inhalation technique. A device that minimizes systemic absorption of these drugs will improve drug safety. The devices of choice are pressurized metered dose-inhalers (pMDIs) with spacers and some dry powder inhalers (DPIs). The main selection criteria for short-acting beta2-agonists are portability and patient acceptability. DPIs and pMDIs are the most suitable systems for these drugs. Cost is an important consideration for both drug types.

Administration, Inhalation↗
PubMedDate not supplied

How pediatricians in Spain manage the first acute wheezing episode in an atopic infant. Results from the TRAP study.

BACKGROUND: Although the treatment of asthma has been addressed in several guidelines, the management of the first acute wheezing episode in infants has not often been evaluated. We surveyed practicing pediatricians in Spain about the treatment they would provide in a simulated case. MATERIAL AND METHODS: A random sample of 3000 pediatricians and physicians who normally treated children was surveyed. The questionnaire inquired about how they would treat a first mild-to-moderate wheezing attack in a 5-month-old boy with a personal and family history of allergy. Pediatricians were asked about their professional background. RESULTS: A total of 2347 questionnaires were returned with useful data (78.2%). Most (90.4%) of the pediatricians would use a short-acting beta2 agonist (SABA) via a metered-dose inhaler with a spacer and a face mask or nebulizer. However, only 34.5% chose a SABA alone: 31.3% added an oral steroid and 27.6% added an inhaled corticosteroid (ICS). The factors associated with the use of ICS in the acute attack were: (1) lack of specific training in pediatrics (OR 1.45; 1.12-1.85) and (2) primary care health center setting (OR 1.31; 1.01-1.69) or rural setting (OR 1.28; 1.01-1.66). Forty-four percent did not recommend any follow-up treatment while 20.7% prescribed ICS as maintenance therapy. The factors related to this decision were the same as those described above. CONCLUSIONS: The management of a first wheezing episode seems to meet published guidelines among Spanish pediatricians with formal training in pediatrics and in those who work in a hospital setting or in urban areas.

Acute Disease↗
PubMed2000

Preventive effect of 2 and 10 mg of sodium cromoglycate on exercise-induced bronchoconstriction.

UNLABELLED: This double-blind, randomised and cross-over study was designed to compare the preventive effect against exercise-induced bronchoconstriction (EIB), defined as the percentage decrease in FEV1 > or = 15% after 6 min of exercise, of 2 mg and 10 mg of sodium cromoglycate (SCG), administered through a metered dose inhaler via spacer, in asthmatic children. Each of the 30 subject (age 11.6 +/- 3.2 years) was tested on five occasions. For inclusion, EIB in test1 was required. In tests 2 to 5, all subjects inhaled 2 mg or 10 mg of SCG 20 min and 120 min before exercise in a randomised order. In order to assess excretion of eosinophil protein X (EPX) accompanying EIB, urine samples were collected before and after exercise. The mean percentage fall in FEV1 (+/- SD) in test 1 was 26.8 +/- 9.8%. Inhalation of 2 mg and 10 mg of SCG 20 min before exercise provided a significant preventive effect in 83% and 77% and inhalation 120 min before exercise provided a preventive effect in 63% and 70%, respectively (n = 30). Variance analysis did not reveal a statistically different absolute fall in FEV1 after exercise when both doses (120 min before exercise) were compared (P = 0.356). In an unselected subgroup of 12 children, urinary EPX increased after the challenge without SCG premedication (test 1) (mean change: +48.7 micrograms/mmol creatinine, P = 0.034), whereas no significant increase was found in case of SCG premedication (mean change in microgram/mmol creatinine): 2 mg/20 min: +12.1; 2 mg/120 min: +8.5; 10 mg/20 min: -10.4 and 10 mg/120 min: -23.5; P > 0.1). CONCLUSION: Administration of 10 mg of sodium cromoglycate is no more effective in preventing exercise-induced bronchoconstriction than 2 mg regardless of whether the medication is given 20 or 120 min before exercise. The preventive effect of sodium cromoglycate on exercise-induced bronchoconstriction in asthmatic children is associated with the inhibition of urinary eosinophil protein X excretion.

Administration, Inhalation↗
PubMed1990

Treatment considerations in children aged 0-5 years.

Children in the first year of life have a less satisfactory response to treatment, but it is still worthwhile using bronchodilators by oral or nebulized route. In more severe cases, cromolyn or nebulized steroids are needed. Over 1 year, response to therapy is better and metered-dose inhalers with spacers become an easier way to deliver medication, although in severe acute attacks the nebulized route remains the preferred one.

Administration, Inhalation↗
PubMed2005

Aerosol delivery to young children by pMDI-spacer: is facemask design important?

This study aimed at identifying in a daily-life setting the influence of facemask design on drug delivery via a spacer to young children. In a 4-week randomized crossover study, 24 children (7-23-months old) with recurrent wheeze tested the AstraZeneca, Galemed, and Hans Rudolph facemask combined with the NebuChamber at home. Each mask was tested twice daily for seven consecutive days. Filters positioned between the NebuChamber and facemask trapped the budesonide aerosol (200 microg, Pulmicort). Parents were asked to score the child's degree of cooperation during administration on diary cards. The administration procedure was evaluated through video recordings. Mean filter dose (standard deviation (s.d.)), expressed as % of nominal dose, was 39% (14), 47% (12), and 42% (11) for the AstraZeneca, the Galemed and the Hans Rudolph mask, respectively. Irrespective of the degree of cooperation, the Galemed mask gave significantly higher mean filter doses than the other masks (level of significance) (p < 0.045). Median (range) within-subject dose variability, expressed, as coefficient of variation (CV), was 37% (19-255), 32% (9-114), and 30% (9-115) for the AstraZeneca mask, the Galemed mask and the Hans Rudolph mask, respectively, not significant. Dose variability increased with decreasing cooperation for all three masks (p = 0.007). Drug delivery to young children with recurrent wheeze by means of the NebuChamber can be enhanced using the Galemed facemask. Dose variability seems to be independent of facemask design but mainly depends on cooperation.

Administration, Inhalation↗
PubMed2000

Comparison of pharmacokinetics and systemic effects of inhaled fluticasone propionate in patients with asthma and healthy volunteers: a randomised crossover study.

BACKGROUND: Inhaled corticosteroids are currently the cornerstone of asthma treatment. Some studies of high-dose fluticasone propionate in patients with no or mild asthma have, however, suggested substantial systemic absorption. We investigated the pharmacokinetics of fluticasone propionate in patients with asthma receiving appropriate doses for severity. METHODS: We did a double-blind, randomised, crossover study in 11 patients with asthma and 13 matched healthy controls (age 20-65 years; asthma patients forced expiratory volume in 1 s <75% and stable on high-dose inhaled corticosteroids). Patients received one 1000 microg intravenous dose or 1000 microg daily for 7 days inhaled (via spacer device) fluticasone propionate. In the 12 h after dosing, we monitored plasma fluticasone propionate and cortisol concentrations by mass spectrometry and competitive immunoassay with use of direct chemiluminescence. Analysis was by intention to treat. FINDINGS: After inhalation, geometric mean values were significantly lower in the asthma group than in controls for fluticasone propionate plasma area under curve (1082 [95% CI 850-1451] vs 2815 pg mL(-1) h(-1) [2262-3949], -62% difference [45-72]; p<0.001), maximum concentrations (117 [91-159] vs 383 pg/mL [302-546], -68% [-50 to -81]; p<0.001), and systemic bioavailability (10.1 [7.9-14.0] vs 21.4% [15.4-32.2], -54% [-27 to -70]; p=0.001). Intravenous-dose clearance, volume of distribution at steady state, plasma half-life, and mean residence time, were similar in the two groups. Less suppression of plasma cortisol concentrations was seen in the asthma group than in controls 4-12 h after inhaled fluticasone propionate. INTERPRETATION: Systemic availability of fluticasone propionate is substantially less in patients with moderate to severe asthma than in healthy controls. Inhaled corticosteroids that are absorbed through the lungs need to be assessed in patients who are receiving doses appropriate for disease severity, and not in normal volunteers.

Administration, Inhalation↗
PubMed1995

Optimizing inhaled drug delivery in patients with asthma.

Successful management of asthmatic patients depends on achieving adequate delivery of inhaled drugs to the lung. This assumes particular importance for inhaled corticosteroids where the therapeutic goal should be to achieve a high ratio of airway anti-inflammatory efficacy to local and systemic side effects. The availability of user-friendly inhaler devices requires a critical appraisal of their effectiveness and an evaluation of whether improved lung deposition of anti-asthma drugs translates into improved clinical efficacy. There is evidence to suggest that the routine use of large-volume spacers for inhaled corticosteroids may not be the best first-line option, in that reduced drug delivery is associated with multiple actuations, inhalation delay and the presence of static electricity. Breath-actuated pressurized aerosol devices or dry powder inhaler devices may be a better option for many asthmatic patients, although the efficiency of drug delivery varies considerably between these devices. There is good evidence with a reservoir dry powder inhaler device to show that improved lung deposition translates into better therapeutic response, both in terms of beta 2-agonist and corticosteroid delivery. For inhaled corticosteroids, such as fluticasone propionate and budesonide, there is evidence to show that systemic bioactivity is mainly determined by lung bioavailability rather than gastrointestinal bioavailability, because of the absence of first-pass metabolism of these drugs in the lung. There is also evidence to show that the greater glucocorticoid potency of fluticasone propionate translates directly into greater systemic bioactivity, but not into enhanced efficacy, at doses above 1 mg daily. The use of efficient delivery systems, such as the reservoir dry powder inhaler device, may not only improve control of asthma and compliance with therapy, but may also allow dose reduction ('step-down' therapy) and hence may possibly reduce overall prescribing costs in the long term.

Anti-Asthmatic Agents↗
PubMed1995

The effect of delay, multiple actuations and spacer static charge on the in vitro delivery of budesonide from the Nebuhaler.

A multistage liquid impinger was used to determine the amount of budesonide available from the Nebuhaler spacer device following alteration of spacer static charge, delay in sampling from the spacer, and multiple actuations of the metered dose inhaler into the spacer prior to sampling. The mean amount of budesonide (s.d.) recovered per 200 micrograms actuation in particles smaller than 5 microns increased from 30.5 micrograms (8.8) to 69.3 micrograms (17.9) with a low static spacer. A 20 s delay between actuation and inhalation reduced the amount recovered to 10.9 micrograms (3.2), but no reduction was seen when using a low static spacer after the same delay. Multiple actuations into the spacer before sampling also reduced the recovery to 24.8 micrograms (3.4) after two actuations, and 13.5 micrograms (7.6) after five actuations. When using a Nebuhaler with budesonide metered dose inhalers, more respirable drug will be obtained if the aerosol is inhaled immediately after actuation, and multiple actuations into the spacer device are avoided. Low static spacers may also improve drug delivery. Attention to the details of spacer use may reduce the incidence of therapeutic failure and the cost of inhaled medications.

Administration, Inhalation↗
PubMed1985

Spacer devices used with metered-dose inhalers. Breakthrough or gimmick?

In an effort to improve the delivery of a drug to the lungs, to correct problems of hand-lung discoordination, and to reduce local side effects such as oral candidiasis, a number of spacer devices have been developed to attach to metered-dose inhalers. Administration of bronchodilator drugs to patients with faulty techniques of inhalation has been improved with the addition of spacers. In adults and older children with a correct technique of inhaling bronchodilators, the spacer devices do not seem to have any advantage over the simple metered-dose inhalers. Young children (two to five years) can benefit from inhaled bronchodilators or corticosteroids by use of spacer devices with one-way valves. Older children and especially adults who suffer from dysphonia or thrush from inhaled corticosteroids can also benefit from spacers. In patients whose condition is well controlled with the usual inhaled doses of corticosteroids with no local side effects, spacer devices show promise, but more studies are needed.

Administration, Topical↗
PubMed1989

[Beta 2 adrenergic and synthetic atropine drugs as inhalants in asthma in children].

Inhaled medication is a well-known treatment for asthma in childhood, because it is rapidly effective, in low doses, and without resultant side effects. The usual methods of aerosol formation are nebulization, metered-dose inhaler and spacers. We have reviewed the standard devices available and their use with sympathomimetic agents and synthetic atropines.

Administration, Inhalation↗
PubMed2002

Management of children with severe asthma exacerbation in the emergency department.

Although acute asthma is a very common cause of emergency department visits in children, there is as yet insufficient evidence for the establishment of a standardized treatment protocol. The aim of this review is to describe updated information on the management of asthma exacerbations in the pediatric emergency department. Oxygen is the first-line treatment of acute asthma exacerbations in the emergency department to control hypoxemia. It is accompanied by the administration of beta(2)-adrenoceptor agonists followed by corticosteroids. beta(2)-Adrenoceptor agonists have traditionally been administered by nebulization, although spacers have recently been introduced and proven, in many cases, to be as effective as nebulization. Oral prednisolone, with its reliability, simplicity, convenience and low cost, should remain the treatment of choice for the most severe asthma exacerbations, when the lung airways are extremely contracted and filled with secretions. Recently, several studies have shown that high-dose inhaled corticosteroids are at least as effective as oral corticosteroids in controlling moderate to severe asthma attacks in children and therefore should be considered an alternative treatment to oral corticosteroids in moderate to severe asthma attacks. Studies of other drugs have shown that ipratropium bromide may be given only in addition to beta(2)-adrenoceptor agonists; theophylline has no additional benefit, and magnesium sulfate has no clear advantage. Comprehensive asthma management should also include asthma education, measures to prevent asthma triggers, and training in the use of inhalers and spacers. Proper management will avoid most asthma attacks and reduce admission and readmission to emergency departments.

Adrenal Cortex Hormones↗
PubMed2001

Respiratory deposition patterns of salbutamol pMDI with CFC and HFA-134a formulations in a human airway replica.

This paper describes a technique that uses a well-defined human airway replica and gamma counting as a standard method for evaluating and comparing the performance of medical inhalers and spacers. High-fidelity replicas reproduced as needed from master casts made from human cadavers include the oropharyngeal cavity, larynx, trachea, and five to nine generations of bronchi. Deposition in the small airways and alveoli region of the cast is simulated by material that passes through the upstream airways and is collected on foam filters. Deposition patterns in the respiratory tract replica were obtained by using radiolabel in the medical inhaler and by gamma scintigraphy. This technique was used to determine respiratory deposition patterns of salbutamol in a pressurized metered dose inhaler (pMDI) with chlorofluorocarbon (CFC, in-house formulation) and HFA-134 formulations (Proventil hydrofluoroalkane [HFA]). At an inspiration flow of 30 L/min, patterns in the salbutamol/CFC formula showed a high deposition in the oropharyngeal airway (78%) and a 16% deposition in the lung, similar to in vivo measurements reported in the literature. However, the salbutamol/HFA formula showed lower oral deposition (56%) but higher lung deposition (24%). The difference in the oral deposition patterns may be attributed to lower initial spray velocity, initial droplet evaporation rate, and possibly initial droplet sizes of Proventil HFA. The small orifice diameter (0.25 mm) of the Proventil HFA actuator produced a softer plume with a smaller impact force, resulting in lower oropharyngeal deposition. Cascade impactor measurements showed similar aerodynamic particle size distribution of the CFC and HFA formulations. We also showed that using spacers in the Proventil HFA resulted in a lower oropharyngeal deposition and higher lung deposition, indicating beneficial effects. Comparison of oropharyngeal deposition and those predicted by artificial throats used in the impactor measurements showed that, in general, the artificial throat predicted a lower deposition.

Administration, Inhalation↗