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Albuterol used with a spacer device which induced atrial fibrillation is described. Inhaled sympathomimetics have been extensively studied for the treatment of asthma and have generally been found to be safe from cardiac arrhythmias. A review of the literature is presented.
OBJECTIVES: To determine the variation in the methods used to assess and interpret the reversibility of airflow limitation in lung-function laboratories throughout Australia and New Zealand. DESIGN: A postal survey performed in 2000, requesting details of methods used to assess and interpret bronchodilator reversibility. SETTING AND PARTICIPANTS: 60 lung-function laboratories identified from the Australian and New Zealand Society of Respiratory Science mailing list. MAIN OUTCOME MEASURES: Bronchodilator agent, dose, mode of administration, time to repeat spirometry and definition of a significant response. RESULTS: 37 laboratories responded (response rate, 64%). Thirty-three laboratories used salbutamol as their routine bronchodilator agent. Twenty-four laboratories used a metered-dose inhaler (MDI) with (21) or without (3) a spacer device as the preferred mode of bronchodilator administration. There was wide variation in the bronchodilator dose administered (median, 400 micro g; range, 200-800 micro g salbutamol for MDIs) and the time to repeat spirometry following bronchodilator administration (median, 10 min; range, 4-20 min). Ten laboratories used criteria consistent with either the National Asthma Council or Thoracic Society of Australia and New Zealand COPDX guidelines to define a significant bronchodilator response, and two used American Thoracic Society criteria. The remaining 25 respondents listed a variety of other criteria. CONCLUSION: The methods used to assess and interpret acute bronchodilator reversibility in lung-function laboratories in Australia and New Zealand vary considerably. This may have a significant effect on the diagnosis and management of patients. Laboratories should report the method used to assess bronchodilator response.
OBJECTIVE OF THE STUDY: To determine the maximal bronchodilator dose of procaterol and pirbuterol administered by inhalation with an without an aerochamber (Aerocâmera) to children with acute bronchial asthma attacks. TYPE OF STUDY: Prospective. 18 children (6-15 years of age) with acute bronchial asthma attacks (FEV1 < 80% of the predicted value) received pirbuterol (N = 10) or procaterol (N = 8) by metered-dose inhaler, one puff every 5 minutes, for a total of five doses. During another acute attack, the same patient received the same medication with the aid of a spacer (Aerocâmera). Clinical evaluation and pulmonary function tests were performed 5 minutes after each inhaled dose. RESULTS: For both drugs, maximal bronchodilation was obtained after the second dose. No significant side effects were observed even after procaterol doses of 50 micrograms or pirbuterol doses of 1000 micrograms. The results were unaffected by the use of the spacer. CONCLUSIONS: The doses that induced maximal bronchodilation were 400 micrograms pirbuterol and 20 micrograms procaterol. Although the spacer did not change the results, it is a valuable aid for patients who have difficulty in using the metered-dose inhaler (M.D.I.).
Historically, inhaled placebos have been provided by pharmaceutical companies and have been widely used by nurses both in primary and secondary care to teach respiratory patients how to use prescribed inhaled therapy. Over recent years, the author of this article has had concerns about the potential risk of cross-infection as a result of reusing placebos with disposable mouthpieces. This concern has been heightened by the lack of verbal and written guidance from the pharmaceutical companies that provide these placebos. There are no recognized protocols or guidelines on the most effective cleaning methods that would minimize or prevent cross-infection. The cleaning of large volume spacers, which are used to enhance a patient's inhaler technique, are particularly problematic as it is not possible to use a disposable mouthpiece with this device. In response to this problem, a cross-sectional, multicentre, regional audit was designed to identify the decontamination process adopted by nurses working in the fields of respiratory care and infection control. The audit outcome confirmed that nurses were using a number of different cleaning methods, with no sound evidence base to support their chosen methods of decontamination. This is an issue that requires further investigation and clarification if nurses are to continue assessing patients' techniques with inhaled devices.
OBJECTIVE: To develop a set of comprehensive, standardized evidence-based guidelines for the assessment and treatment of acute asthma in adults in the emergency setting. OPTIONS: The use of medications was evaluated by class, dose, route, onset of action and optimal mode of delivery. The use of objective measurements and clinical features to assess response to therapy were evaluated in relation to the decision to admit or discharge the patient or arrange for follow-up care. OUTCOMES: Control of symptoms and disease reflected in hospital admission rates, frequency of treatment failures following discharge, resolution of symptoms and improvement of spirometric test results. EVIDENCE: Previous guidelines, articles retrieved through a search of MEDLINE, emergency medical abstracts and information from members of the expert panel were reviewed by members of the Canadian Association of Emergency Physicians (CAEP) and the Canadian Thoracic Society. Where evidence was not available, consensus was reached by the expert panel. The resulting guidelines were reviewed by members of the parent organizations. VALUES: The evidence-based methods and values of the Canadian Task Force on the Periodic Health Examination were used. BENEFITS, HARMS AND COSTS: As many as 80% of the approximate 400 deaths from asthma each year in Canada are felt to be preventable. The use of guidelines, aggressive emergency management and consistent use of available options at discharge are expected to decrease the rates of unnecessary hospital admissions and return visits to emergency departments because of treatment failures. Substantial decreases in costs are expected from the use of less expensive drugs, or drug delivery systems, fewer hospital admissions and earlier return to full activity after discharge. RECOMMENDATIONS: Beta2-agonists are the first-line therapy for the management of acute asthma in the emergency department (grade A recommendation). Bronchodilators should be administered by the inhaled route and titrated using objective and clinical measures of airflow limitation (grade A). Metered-dose inhalers are preferred to wet nebulizers, and a chamber (spacer device) is recommended for severe asthma (grade A). Anticholinergic therapy should be added to beta 2 agonist therapy in severe and life-threatening cases and may be considered in cases of mild to moderate asthma (grade A). Aminophylline is not recommended for use in the first 4 hours of therapy (grade A). Ketamine and succinylcholine are recommended for rapid sequence intubation in life-threatening cases (grade B). Adrenaline (administered subcutaneously or intravenously), salbutamol (administered intravenously) and anesthetics (inhaled) are recommended as alternatives to conventional therapy in unresponsive life-threatening cases (grade B). Severity of airflow limitation should be determined according to the forced expiratory volume at 1 second or the peak expiratory flow rate, or both, before and after treatment and at discharge (grade A). Consideration for discharge should be based on both spirometric test results and assessment of clinical risk factors for relapse (grade A). All patients should be considered candidates for systemic corticosteroid therapy at discharge (grade A). Those requiring corticosteroid therapy should be given 30 to 60 mg of prednisone orally (or equivalent) per day for 7 to 14 days; no tapering is required (grade A). Inhaled corticosteroids are an integral component of therapy and should be prescribed for all patients receiving oral corticosteroid therapy at discharge (grade A). Patients should be given a discharge treatment plan and clear instructions for follow-up care (grade C). VALIDATION: The guidelines share the same principles of those from the British Thoracic Society and the National Institutes of Health. Two specific validation initiatives have been undertaken: (a) several Canadian centres have been involved in the collection of comprehensive administrative data to assess compliance and outcome measures and (b) a survey of Canadian emergency physicians conducted to gather baseline informaton of treatment patterns, was conducted before development of the guidelines and will be repeated to re-evaluate emergency management of asthma.
BACKGROUND: Early use of inhaled steroids is recommended for bronchial asthma. The side effects are rare, but oral discomfort and candidiasis are clinically important complications. Most previous studies reported that the use of spacer and water gargling was necessary to prevent oral complications. However, in some patients, this may fail to prevent such complications. OBJECTIVE: To compare the effects of water gargling with those of amphotericin B, in the prevention of oral complications in asthmatics using inhaled steroids. METHODS: Pharyngeal swab samples were obtained aseptically from the posterior pharyngeal wall of 128 asthmatics who have been using inhaled steroids (beclomethasone dipropionate) for more than 1 year. The amount of Candida albicans in cultured swabs was evaluated based on the following criteria: oral symptoms, method of gargling, dose of inhaled steroids, type of spacer and serum cortisol level. RESULTS: The number of isolated C. albicans was significantly higher in asthmatics with oral symptoms than in those free of symptoms. It was also significantly higher in patients who gargled with water or 1,000 times dilution than in those who gargled with 100 or 50 times dilutions of amphotericin B. Moreover, it was significantly higher in patients with low levels of serum cortisol than in those with normal serum cortisol. CONCLUSION: We demonstrated that at least in a subgroup of asthmatics using steroid inhalers, gargling with water or even weak concentrations of amphotericin B does not prevent colonization of the throat with C. albicans. This group at high risk of developing oral candidiasis should gargle with amphotericin B at concentrations higher than 100 times dilution that can prevent clinically detectable oral candidiasis.
In the drive to replace chlorofluorinated hydrocarbons (CFCs) by alternative more environmentally friendly propellants in pressurized metered dose inhalers (pMDIs), Chiesi has developed new inhalers using Modulite technology. The aim was to obtain CFC-free pMDIs which are equivalent, in terms of safety and efficacy, to the previous CFC devices at the same dose. When beclometasone dipropionate (BDP) and budesonide Modulite formulations were compared to the equivalent CFC products there was no significant difference in morning serum cortisol or urinary cortisol excretion, at the maximum recommended daily dose (2000 micrograms or 1600 micrograms respectively). Single dose pharmacokinetic studies in both healthy volunteers and asthmatic patients compared systemic exposure (B17MP levels) for BDP-CFC with BDP Modulite and extrafine BDP-HFA (QVAR). B17MP levels for BDP-CFC and BDP Modulite were comparable, but substantially less than that seen with extrafine BDP-HFA. After 6 weeks of treatment in asthmatic patients, B17MP AUC after inhalation of BDP (1000 micrograms twice-daily) from BDP Modulite was comparable with that obtained after BDP-CFC (Becloforte). Plasma profile of BDP and B17MP were similar after inhalation from BDP Modulite with standard actuator or delivered via a spacer, suggesting that pulmonary delivery of BDP to the lung is similar with both actuators.
Metered-dose inhalers (MDIs) have become a mainstay of maintenance therapy for various allergic and respiratory conditions. When used correctly, MDIs are as effective as nebulized medications. Patients use MDIs incorrectly in many cases because of poor instruction and lack of spacer devices. Nurses and physicians often teach the technique improperly. Nurse practitioners can have a positive impact in improving care through better patient and staff teaching and the use of spacer devices with MDIs.
Inhalation is the preferred route for asthma therapy, since it offers a rapid onset of drug action, requires smaller doses, and reduces systemic effects compared with other routes of administration. Unfortunately, inhalation devices are frequently used in an empirical manner rather than on evidence-based awareness.A wide variety of nebulizers are available. Conventional jet nebulizers are highly inefficient, as much of the aerosol is wasted during exhalation. However, incorporating an extra open vent into the system has considerably increased the amount of drug that patients receive. Breath-assisted open vent nebulizers limit the loss of aerosol during exhalation, but are dependent on the patient's inspiratory flow. Ultrasonic nebulizers produce a high mass output and have a short nebulization time, but are inefficient for delivering suspensions or viscous solutions. Adaptive aerosol delivery devices release a precise dose that is tailored to the individual patient's breathing pattern. Nebulizers have several drawbacks, and their use should be limited to patients who cannot correctly manage other devices.Pressurized metered-dose inhalers (pMDI) are practical, cheap and multidose. However, there are several problems with their use. Breath-actuated MDI are easy to use and can be activated by very low flow. However, young children may not be able to use them efficiently. Dry powder inhalers (DPI) are portable and easy to use. They are indicated either for rescue bronchodilator therapy or for regular treatment with inhaled corticosteroids and long-acting bronchodilators. The use of spacers reduces oropharyngeal deposition and improves drug delivery to the lung. Spacers do not require patient coordination, but some general rules must be followed for their optimal use.Thus, the choice of a delivery device mainly depends on the age of the patient, the drug to be administered and the condition to be treated. Proper education is also essential when prescribing an inhalation device.
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Pulmonary distribution and lung functions were evaluated during a 4-month inhaled corticosteroid treatment period in 10 steroid-naïve novel asthmatics with normal or slightly reduced lung functions. Patients were given a total daily dose of 1000 microg of beclomethasone dipropionate aerosol twice a day via a pressured metered dose inhaler with a large-volume chamber device (Volumatic, GlaxoSmith Kline, U.K.). Gamma lung scintigraphy and lung function tests were performed before and after 2 months and 4 months. Inhaled 99mTc-labelled beclomethasone dipropionate liposomes were used to assess lung deposition patterns during inhaled steroid therapy. Serum eosinophil cationic protein (ECP) concentration was used as a surrogate marker of asthmatic inflammation. Following beclomethasone treatment, all lung functions were enhanced, but only FVC values showed significant improvement. The FEV1/FVC ratio remained slightly reduced in spite of inhaled corticosteroid therapy. However, the association between changes in improved FVC values and reduced ECP levels proved to be statistically significant. In lung scintigraphy, no evidence of changes in pulmonary deposition patterns were seen during the follow-up period. We conclude that inhaled corticosteroid therapy can lead to improvements in lung functions and surrogate markers of airway inflammation in novel asthma without affecting the peripheral deposition pattern of aerosols.
OBJECTIVE: To investigate effects on adrenal function of fluticasone, a recently released inhaled steroid preparation with lower systemic bioavailability than beclomethasone dipropionate. METHODS: 34 children on high doses (400-909 micrograms/m2/d) of inhaled beclomethasone dipropionate or budesonide were recruited into a double blind, crossover study investigating the effects on adrenal function of beclomethasone and fluticasone propionate, given using a standard spacer (Volumatic). The 24 hour excretion rates of total cortisol and cortisol metabolites were determined at baseline (after a two week run in), after six weeks treatment with an equal dose of beclomethasone, and after six weeks of treatment with half the dose of fluticasone, both given through a spacer device. RESULTS: The comparison of effects between fluticasone and beclomethasone during treatment periods, although favouring fluticasone in all measured variables, reached significance only after correction for urinary creatinine excretion (tetrahydrocortisol and 5 alpha-tetrahydrocortisol geometric means: 424 v 341 micrograms/m2/d). The baseline data showed adrenal suppression in the children taking beclomethasone (total cortisol geometric means: 975 v 1542 micrograms/d) and a dose related suppression in the children taking budesonide. Suppressed adrenal function in the children who were taking beclomethasone at baseline subsequently improved with fluticasone and beclomethasone during treatment periods. CONCLUSIONS: Fluticasone is less likely to suppress adrenal function than beclomethasone at therapeutically equivalent doses. The baseline data also support the claim that spacer devices should be used for the administration of high doses of inhaled topical steroids.
The aim of this study was to determine whether electrostatic charge on a plastic spacer decreases the delivery of salbutamol from a pressurized metered-dose inhaler (pMDI) and, if so, to find an optimal and practical treatment to remove the charge. Ten single actuations from a salbutamol pMDI were drawn through different Volumatic spacers at a constant flow of 60 L.min-1. The efficacies of different methods of removing charge were tested, including detergent coating of the spacers. A multistage liquid impinger was used to determine the particle size distribution of the output of the pMDI through the Volumatic spacers. The electrostatic charge on the inner surface of the spacers was measured both quantitatively with an electrometer, and qualitatively by the attraction of a thin strip of cellulose membrane to the wall of the spacer. Each experiment was repeated four times. Ionic detergent coating of the spacers removed the charge for at least 24 h. This resulted in an increase of 55-70% in small particle (< 6.8 microns) delivery compared to delivery from new spacers with high charge. We have demonstrated that electrostatic charge plays a major role in the delivery of salbutamol through plastic spacers. Adequate treatment with ionic detergent removes the charge and improves drug delivery.
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OBJECTIVE: To introduce readers to the current controversial topics in the area of asthma therapy. Background is provided such that clinicians are aware of these issues and can make rational decisions. DATA SOURCES: Pertinent articles were individually identified and reviewed from each journal. STUDY SELECTION: Relevant studies, determined by topic and other specific criteria, e.g., testing methodology, were included. DATA SYNTHESIS: Further investigation is required in the areas discussed. Systemic effects, specifically growth suppression (in children), adrenal suppression, and osteoporosis, have been demonstrated with high-dose inhaled glucocorticoids; however, the clinical relevance of such intravenous glucocorticoid formulations via nebulizer have not been demonstrated. Likewise, data on the equivalence of the inhaled glucocorticoids, with regard to efficacy and potential systemic effects, and the differences between metered-dose inhalers and dry powder inhalers, with regard to aerosol characteristics and drug delivery, are unclear. Theophylline, when used with inhaled beta-adrenergic agonists and systemic glucocorticoids for the treatment of acute asthma, as not been shown to provide clear benefit and may result in increased adverse effects. The use of regular (vs. "as needed" or prn) inhaled beta-adrenergic agonists, although shown in two studies to be detrimental to the control of asthma and result in an increased risk of death or near death caused by asthma, has not been conclusively demonstrated to be harmful. CONCLUSIONS: Monitoring for adverse effects and the use of techniques to minimize systemic absorption (spacers and mouth rinsing) are recommended when high-dose inhaled glucocorticoid therapy is used. Intranasal and intravenous glucocorticoid products are not recommended for administration via nebulizer because of safety concerns. Until further data are available, inhaled glucocorticoids are thought to be equivalent on a microgram-per-microgram basis rather than an actuation-per-actuation basis. Theophylline is no longer recommended for treatment of acute exacerbations in nonhospitalized patients not already receiving the medication, and the link between deterioration of asthma control (and the risk for death) and regular inhaled beta-adrenergic agonists appears weak.
Eighteen subjects with moderate asthma participated in this double-blind study comparing the bronchodilator response to albuterol or placebo used in conjunction with three inhalation devices; the metered dose inhaler (MDI) actuator alone, the AeroChamber, and the OptiHaler. The principal comparison was the increase in FEV1 over 30 minutes. Also recorded were heart rate, time required to use each device, and patient acceptance of each device. There was a large bronchodilator response with albuterol with each of the devices, but there was no difference in the promptness or the magnitude of the bronchodilator response among the three devices. There was a small but statistically significant increase in heart rate which did not differ among devices. Subject ratings of acceptability were MDI alone best, followed by OptiHaler, then AeroChamber. We conclude (1) the bronchodilator response obtained with use of the MDI alone, the AeroChamber and OptiHaler were not significantly different; (2) patients, as a group, found the MDI required less time to use and they favored it over either spacer; (3) while in subjects employing good MDI technique, the addition of either an AeroChamber or an OptiHaler did not improve bronchodilator response. Spacers may have a role in those with poor inhaler technique or in conjunction with inhaled corticosteroids.
OBJECTIVE: We investigated the clinical response to equivalent doses of salbutamol delivered, via metered dose inhaler (MDI) during non-invasive mechanical ventilation (NIMV-MDI), during spontaneous breathing using a spacer (MDI-Spacer), and also during intermittent positive pressure breathing (IPPB). SETTING: A respiratory intensive care unit. DESIGN: Prospective, randomized, and placebo-controlled study. PATIENTS: Eighteen stable patients with chronic obstructive pulmonary disease (mean FEV1=38.5+/-8.8% predicted). RESULTS: Overall salbutamol administration induced, compared to placebo, a significant improvement in FEV1, irrespective of the mode of administration (+7.9+/-7.1% or +108+/-91 ml for IPPB, +9.6+/-8.8% or 112+/-67 ml for MDI-NIMV (inspiratory pressure=14.3+/-1.8 cmH2O; expiratory pressure=none), and +10.8+/-11.4% or 119+/-114 ml for MDI-Spacer, respectively). DeltaFVC significantly increased from placebo only in MDI-NIMV (+214+/-182 ml P=0.02). A second set of experiments performed in eight patients to ascertain the possible effect of NIMV on pulmonary function tests, showed a significant improvement from baseline values in FVC both after the delivering of placebo or salbutamol via NIMV-MDI (+206+/-147 ml and 208+/-145, respectively). FEV1 significantly increased only after salbutamol. No changes in gas exchange were observed after bronchodilator delivery. CONCLUSIONS: We show that delivery of bronchodilators via MDI with a spacer chamber during NIMV is feasible and induces a significant bronchodilator effect compared to placebo, even though it may be slightly less effective than the classical delivery system (MDI-Spacer).
The objective of this study was to evaluate the effects of inhaled flunisolide (FN) and triamcinolone acetonide (TAA) on basal and dynamic adrenocortical activity. A randomized cross-over design was used, comparing placebo (PL), low (L) and high (H) doses of FN (Aerobid; 250 microg/actuation; without spacer; L, 1000 microg; H, 2000 microg/day), and TAA (Azmacort; 100 microg/actuation; with integrated actuator/spacer; L, 800 microg; H, 1600 microg/day). Each dose was given at 0800 and 2200 h for 3 days, and treatments were separated by a 10-day washout. Twelve normal volunteers (mean +/- SE age, 24.2 +/- 2.4 yr) were studied. After 3 days of treatment, blood samples were taken before ACTH stimulation at 0800 h (10 h after the sixth dose) and after ACTH (0.5 microg) stimulation for determination of serum cortisol. Overnight (starting at 2200 h on the third day of treatment) and early morning urine collections were taken for measurements of urinary cortisol corrected for creatinine excretion. For serum cortisol (pre- and post-ACTH stimulation), there was no significant difference compared with placebo for either drug. Post-ACTH cortisol (nanomoles per L) values were: PL, 666.3; H FN, 617.0; H TAA, 591.4; L FN, 699.2; and L TAA, 686.0. For overnight corrected urinary cortisol/creatinine excretion (nanomoles per mmol) compared with PL (6.4), there was a significant suppression (P < 0.05) at the high dose of both drugs (H FN, 2.6; H TAA, 2.3) but not at the low dose (L FN, 4.2; L TAA, 4.5). Likewise, values for early morning corrected urinary cortisol/creatinine (nanomoles per mmol) showed significant suppression (P < 0.05) only with high doses of both drugs (PL, 39.0; H FN, 26.5; H TAA, 26.6; L FN, 37.2; L TAA, 36.5). The following conclusions were reached. 1) Overnight and early morning corrected urinary cortisol/creatinine excretion was more sensitive at detecting adrenocortical suppression than basal 0800 h serum cortisol or response to 0.5 microg ACTH stimulation. 2) There were no significant differences between inhaled FN (without spacer) and TAA (with integrated actuator/spacer), which only produced detectable adrenocortical suppression at the highest recommended doses and was not associated with impaired adrenal reserve. 3) Even at the high dose, the suppression observed with both drugs is unlikely to be of clinical relevance.