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PubMed1989

Dosimetric principles for extrapolating results of rat inhalation studies to humans, using an inhaled Ni compound as an example.

Dose-effect relationships of inhaled substances are complicated by the interrelationship between inhaled dose, deposited dose, and retained dose. Deposited and retained doses are most important for evaluating dose-effect relations; however, inhaled dose and exposure concentration that are not representative of the actual dose to target sites are widely used for this purpose. For extrapolating results of animal inhalation studies to humans, several factors have to be considered for calculating a human equivalent dose to the respiratory tract and for estimating a human equivalent exposure concentration. Among these factors are separate deposition in nasopharyngeal, tracheobronchial, and alveolar regions, both total regional deposition and deposited dose per unit surface area. Predictive particle deposition models for the respiratory tract can be used for calculating these. The retained dose is another factor that takes into account respiratory tract retention and determines the long-term dose to the respiratory tract. A rat inhalation study using Ni3S2 exposure (concentration, 970 micrograms m-3; duration, 78 wk; exposure, 6 h d-1, 5 d wk-1) resulted in bronchogenic and alveologenic tumors. Extrapolation modeling of rat data was performed based on dose factors discussed above, and assuming different conditions of pulmonary retention for Ni3S2 with half-times of 36 d for rats and 103 d for humans. Model calculations showed that deposited surface area dose was greater for the tracheobronchial than for the pulmonary region in both rat and man. The retained dose per gram of lung was greater in rat than in man under resting conditions. An equivalent exposure concentration would be lower in humans than in the rat if it is based on the retained dose expressed per square centimeter of alveolar surface area. However, inhaled equivalent concentration in man can be considerably higher when the tracheobronchial surface area dose is considered. The most sensitive region of the respiratory tract--for example, with regard to tumor induction--should be selected for estimating human equivalent exposure.

Administration, Inhalation↗
PubMed2004

Cumulative high doses of inhaled formoterol have less systemic effects in asthmatic children 6-11 years-old than cumulative high doses of inhaled terbutaline.

OBJECTIVES: To evaluate high dose tolerability and relative systemic dose potency between inhaled clinically equipotent dose increments of formoterol and terbutaline in children. METHODS: Twenty boys and girls (6-11 years-old) with asthma and normal ECGs were studied. Ten doses of formoterol (Oxis) 4.5 microg (F4.5) or terbutaline (Bricanyl) 500 microg (T500) were inhaled cumulatively via a dry powder inhaler (Turbuhaler) over 1 h (three patients) or 2.5 h (17 patients) and compared to a day of no treatment, in a randomised, double-blind (active treatments only), crossover trial. Blood pressure (BP), ECG, plasma potassium, glucose, lactate, and adverse events were monitored up to 10 h to assess tolerability and relative systemic dose potency. RESULTS: Formoterol and terbutaline had significant beta2-adrenergic effects on most outcomes. Apart from the effect on systolic BP, QRS duration and PR interval, the systemic effects were significantly more pronounced with terbutaline than with formoterol. Thus, mean minimum plasma potassium, was suppressed from 3.56 (95% confidence interval, CI: 3.48-3.65) mmol l(-1) on the day of no treatment to 2.98 (CI: 2.90-3.08) after 10 x F4.5 and 2.70 (CI: 2.61-2.78) mmol l(-1) after 10 x T500, and maximum Q-Tc (heart rate corrected Q-T interval [Bazett's formula]) was prolonged from 429 (CI: 422-435) ms on the day of no treatment, to 455 (CI: 448-462) ms after 10 x F4.5 and 470 (CI: 463-476) ms after 10 x T500. Estimates of relative dose potency indicated that F4.5 microg had the same systemic activity as the clinically less effective dose of 250 microg terbutaline. The duration of systemic effects differed marginally between treatments. Spontaneously reported adverse events (most frequently tremor) were fewer with formoterol (78% of the children) than with terbutaline (95%). A serious adverse event occurred after inhalation of 45 microg formoterol over the 1 h dosing time, that prompted the extension of dosing time to 2.5 h. CONCLUSIONS: Multiple inhalations over 2.5 h of formoterol (4.5 microg) via Turbuhaler) are at least as safe as and associated with less systemic effects than multiple inhalations of the clinically equipotent dose of terbutaline (500 microg) in children with asthma.

Administration, Inhalation↗
PubMed1993

The effect of inhaled frusemide on airway sensitivity to inhaled 4.5% sodium chloride aerosol in asthmatic subjects.

BACKGROUND: Frusemide inhaled by asthmatic subjects before a variety of indirect bronchial challenges inhibits the airway response to these challenges. Since inhalation of hyperosmolar saline is an indirect bronchial challenge, the effect of inhaled frusemide and its vehicle on airway sensitivity to a 4.5% sodium chloride (NaCl) aerosol challenge was investigated. METHODS: Eleven asthmatic subjects (five females, six males) who had a 20% fall in forced expiratory volume in one second after 4.5% NaCl challenge were enrolled in this double blind controlled crossover trial. Sensitivity was measured as the dose of aerosol required to provoke a 20% fall in FEV1. Frusemide (33.2 mg) or its vehicle was delivered through a Fisoneb ultrasonic nebuliser and inhaled 10 minutes before challenge with 4.5% NaCl. A Mistogen ultrasonic nebuliser was used to generate the 4.5% NaCl aerosol and FEV1 was measured before and one minute after each challenge period of 0.5, one, two, four, eight, eight and eight minutes. The doubling dose difference for PD20 was calculated. RESULTS: Frusemide or vehicle had no effect on baseline lung function. The geometric mean PD20 after vehicle was 1.3 ml with a 95% confidence interval of 0.7-2.3 and after frusemide was 8.2 ml with a 95% confidence interval of 4.7-14.1. This represented a 2.6 doubling dose increase in PD20 after frusemide inhalation. In five of the 11 subjects an increase from baseline FEV1 occurred after exposure to 4.5% NaCl challenge in the presence of frusemide. This transient bronchodilatation may be caused by the release of prostaglandin E2. CONCLUSION: Inhalation of frusemide is very effective in delaying airway narrowing induced by an aerosol of 4.5% NaCl in asthmatic subjects.

Administration, Inhalation↗
PubMed2000

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

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

Administration, Inhalation↗
PubMed2005

Inhaled ethanolic and aqueous solutions via Respimat Soft Mist Inhaler are well-tolerated in asthma patients.

BACKGROUND: Respimat Soft Mist Inhaler (SMI) is a new-generation inhaler offering improved lung deposition compared with other devices. Bronchodilators administered via Respimat SMI are preserved and stabilized with benzalkonium chloride (BAC) and ethylene diamine tetra-acetic acid (EDTA); both have been reported to cause paradoxical bronchoconstriction if a threshold dose is exceeded. OBJECTIVE: The aim of this randomized, double-blind, three-period, crossover study was to establish that the safety of inhaled ethanolic and aqueous placebo solutions (containing BAC and EDTA) is equivalent to that of inhaled normal saline solution when administered to asthma patients via Respimat SMI. METHODS: Thirty-seven asthma patients with airway hyper-reactivity were randomized to receive four actuations of each of the following three treatments via Respimat SMI, one on each of 3 study days: ethanolic placebo (12 microl 96% ethanol + 0.13 mug EDTA/actuation), aqueous placebo (12 microl water + 5.5 microg EDTA + 1.1 mug BAC/actuation), and normal saline (12 microl 0.9% sodium chloride/actuation). Pulmonary function tests were performed at baseline and at 5, 15, 30, 60, 120 and 180 min after inhalation; the primary endpoint was the lowest FEV(1) recorded between 0 and 30 min. RESULTS: The mean lowest FEV(1) recorded between 0 and 30 min after inhalation minus the study day baseline was -0.090 litres for ethanolic placebo, -0.121 litres for aqueous placebo and -0.094 litres for normal saline (SEM 0.034 litres for all). The mean treatment differences were: ethanolic placebo versus normal saline 0.004 litres (90% CI -0.075-0.083 litres, p = 0.002), and aqueous placebo versus normal saline -0.028 litres (90% CI -0.107-0.052 litres, p = 0.006). Since both 90% CIs fell within the pre-determined equivalence region of +/-0.15 litres, both treatments were considered equivalent to normal saline. CONCLUSION: Ethanolic and aqueous solutions administered via Respimat SMI are safe with regard to paradoxical bronchoconstriction in asthma patients with airway hyper-reactivity.

Administration, Inhalation↗
PubMed1999

Comparison of oral bambuterol and inhaled salmeterol in patients with symptomatic asthma and using inhaled corticosteroids.

Salmeterol inhaled twice-daily is now being used more frequently as additional treatment in asthma insufficiently controlled by inhaled corticosteroids. We compared oral bambuterol in a dose of 20 mg taken once daily in the evening with inhaled salmeterol at 50 microgram taken twice daily in 126 asthmatic patients (60 bambuterol, 66 salmeterol) aged 18 to 74 yr who were treated for at least 4 wk with inhaled corticosteroids at a constant dose of 400 to 2,000 microgram/d or with oral corticosteroids at </= 20 mg/d. The patients were able to use a pressurized metered dose inhaler (pMDI) efficiently, and had an FEV1 of 40 to 85% of the predicted normal value. During a run-in period, patients had to show at least one nocturnal or early awakening caused by asthma symptoms that required rescue medication, and a >/= 15% overnight decrease in peak expiratory flow (PEF) on 3 of the preceding 7 d, in order to be randomized into this double-blind, double dummy, multicenter parallel group study (2-wk run-in period and 6 wk of treatment). There was no significant difference between bambuterol and salmeterol in morning change from baseline in PEF (p = 0.53). The median increases in morning PEF were 50 L/min for bambuterol and 55 L/min for salmeterol. Other variables (evening PEF, percent of overnight decrease in PEF, number of awakenings, percent of nights with an awakening, number of puffs of rescue medication, asthma symptoms during the day and night, and mean tremor score) also showed no significant difference between bambuterol and salmeterol. Both treatments, at the doses given, were well tolerated. Once-daily oral bambuterol is a convenient, effective, and less expensive alternative to twice-daily inhaled salmeterol for treating nocturnal asthma.

Administration, Inhalation↗
PubMed1996

Effect of addition of inhaled salmeterol to the treatment of moderate-to-severe asthmatics uncontrolled on high-dose inhaled steroids. European Respiratory Study Group.

The aim of this study was to assess the efficacy and safety of inhaled salmeterol 100 micrograms b.d. (SM) versus inhaled salbutamol 400 micrograms q.d.s. (SB), both via the Diskhaler, when added to concurrent treatment, in asthmatic patients who were not controlled on high doses of inhaled steroids (> or = 1,500 micrograms beclomethasone dipropionate (BDP) or equivalent daily). This was a multicentre, parallel group, double-blind study in which 190 patients with a forced expiratory volume in one second (FEV1) or peak expiratory flow rate (PEFR) of 30-75% predicted and 15% reversibility to inhaled bronchodilator were randomized to treatment for 6 weeks. In the SM group, morning PEFR increased from 281 to 315 L-min-1 during treatment and in the SB group from 311 to 315 L.min-1 (p < 0.001). The SM group showed significantly better reduction in diurnal variation, from 39 to 22 L.min-1 during treatment, than the SB group (34 to 37 L.min-1) (p < 0.001). There was a significantly greater improvement in FEV1 in the SM group (from 1.63 to 1.85 L) than in the SB group (from 1.79 to 1.84 L). The SM group had significantly more symptom-free nights than the SB group (p < 0.001), and also more "rescue-free" nights (p = 0.04). The adverse event profile was similar in both groups. This study indicates that in asthmatic patients, not controlled on high-dose inhaled steroids, inhaled salmeterol 100 micrograms b.d. significantly improves lung function and reduces asthma symptoms.

Administration, Inhalation↗
PubMed2005

Antibody response to inhaled insulin in patients with type 1 or type 2 diabetes. An analysis of initial phase II and III inhaled insulin (Exubera) trials and a two-year extension trial.

OBJECTIVE: To compare antibody responses to inhaled human insulin vs. sc human insulin and to determine whether insulin antibody binding is associated with adverse clinical consequences. RESEARCH DESIGN AND METHODS: Insulin antibody data from initial phase II/III trials were analyzed comparing the efficacy and safety of inhaled insulin with various agents, including sc insulin. Additionally, data from a 24-month extension of the phase III studies were examined. Data were pooled into the following three groups based on insulin treatment status at baseline: patients with type 1 diabetes, and patients with type 2 diabetes using insulin and not using insulin at baseline. Ig class analysis was also performed on randomly selected sera from type 1 patients at the end of the initial trials. RESULTS: In the initial trials, greater insulin antibody binding was observed in patients receiving inhaled insulin vs. sc insulin. The greatest antibody responses to inhaled insulin were observed in patients with type 1 diabetes [nonparametric comparison of medians at the end of the study, 22.0% binding (unadjusted 95% confidence interval: 19.5, 24.5)], and the lowest responses were observed in non-insulin-using patients with type 2 diabetes in which there was no difference in median values at the end of the study. There were no correlations between antibody binding and glycemic control (measured using glycosylated hemoglobin), insulin dose requirements, hypoglycemic events, or pulmonary function (measured by changes in forced expiratory volume in 1 sec and diffusion capacity of carbon monoxide). Antibody responses were IgG in type. Differences in antibody levels observed in patients with type 1 vs. type 2 diabetes were maintained over the 24-month extension trials. Peak antibody levels across all groups were generally observed after 6-12 months of insulin therapy. Inhaled insulin therapy was not associated with a greater incidence of allergy or other hypersensitivity reactions. CONCLUSION: Inhaled insulin was observed to produce a larger antibody response than sc insulin. Insulin antibody binding has not been associated with adverse clinical consequences in trials to date.

Administration, Inhalation↗
PubMed2002

Delivery of ipratropium and albuterol combination therapy for chronic obstructive pulmonary disease: effectiveness of a two-in-one inhaler versus separate inhalers.

OBJECTIVE: To determine whether a combined formulation consisting of ipratropium and an inhaled beta2 agonist (2-in-1 therapy) leads to lower respiratory-related healthcare use and charges and improved compliance compared with treatment with separate ipratropium and beta2-agonist inhalers (separate inhaler therapy). STUDY DESIGN: Retrospective inception cohort study. PATIENTS AND METHODS: Healthcare use, charges, and treatment compliance were examined for adults age 38 years or older who initiated ipratropium therapy on or after July 1997, based on health claims data for United Healthcare enrollees from 5 health plans from July 1997 through December 1998. A total of 428 patients received 2-in-1 therapy, and 658 patients received separate inhaler therapy. To adjust for disease severity and other confounders, the following were determined for the preinitiation period: age; sex; use of oral steroids, antibiotics, or albuterol; respiratory-related healthcare use; and respiratory diagnoses. Compliance was defined as not interrupting or discontinuing therapy during the follow-up period. RESULTS: After adjusting for baseline covariates, 2-in-1 therapy users had a significantly lower risk of emergency department use or hospitalization (relative risk = 0.58, 95% confidence interval [CI] = 0.36, 0.94), lower mean monthly healthcare charges (P= .015), shorter hospital stays (2.05 vs 4.61 days, P = .040), and greater likelihood of compliance (odds ratio = 1.77, 95% CI = 1.46, 2.14). CONCLUSION: A single inhaler containing both ipratropium and albuterol can increase compliance and decrease respiratory morbidity and charges over and above the effects achieved with separate inhalers for these 2 agents.

Administration, Inhalation↗
PubMed1994

The rapid and effective administration of a beta 2-agonist to horses with heaves using a compact inhalation device and metered-dose inhalers.

The purpose of the study was to administer therapeutic aerosol generated by metered-dose inhalers to horses exhibiting clinical signs of heaves using a compact inhalation device developed for human medicine. It was fitted to a custom face mask in order to study the effect of an inhaled beta 2-agonist, fenoterol. Pulmonary function testing was performed on six horses following an acute exacerbation of heaves, characterized by tachypnea, wheezes, crackles, and spasmodic cough. Horses inhaled fenoterol in 1 mg increments administered as one 200 microgram puff every 5-10 s with the recording of data 5 min after the cessation of drug inhalation. A significant effect of fenoterol was shown for maximum change in transpulmonary pressure, dynamic compliance, lung resistance, and work of breathing, and the wheezes and crackles disappeared when auscultation was performed at the end of the test. This study demonstrates a novel, highly effective method for the rapid administration of inhaled medication in horses.

Administration, Inhalation↗
PubMed1995

Controversies involving inhaled beta-agonists and inhaled corticosteroids in the treatment of asthma.

Controversy over the use of inhaled beta-agonists has dated almost from their introduction as a treatment for asthma. Their effectiveness as bronchodilators is not disputed, but there is concern that they may worsen asthma control if used regularly and that excessive use may increase the risk of death from asthma. Five years after the report from Sears and colleagues suggested that regular use of fenoterol worsens asthma control, we do not have definitive corroborative evidence that this effect of fenoterol is real or is shared by other members of the beta-agonist class. It also remains disputed whether the documented association between excessive beta-agonist use and death from asthma is a causal or a spurious association. Undisputed is the fact that excessive beta-agonist use by asthmatics indicates an increased risk of death from asthma and so indicates a need for clinicians to advise anti-inflammatory medications for these patients. Happily, although there are legitimate concerns about the possible implications of the development of tolerance to the non-bronchodilating effects of beta-agonists, there is currently little evidence that treatment with conventional doses of the beta-agonists currently available in the United States, including salmeterol, is harmful to asthmatic patients. The controversies over the use of inhaled corticosteroids revolve around the issue of whether the clinical benefit easily demonstrated with their short-term use is justified in the face of their possible long-term systemic toxicity. Unsettled questions about their therapeutic use include whether dose dependence can be shown for the clinical benefits of inhaled corticosteroids, whether delay in initiating inhaled corticosteroid treatment reduces the benefit that can be achieved, and whether the benefits of even prolonged therapy are short-lasting. The great unsettled question about their toxicity is whether systemic absorption of inhaled corticosteroids increases the risk of long-term systemic complications, like osteoporosis, cataracts, and growth inhibition. Current evidence suggests that significant risk of such toxicity is not likely to be associated with the long-term use of the equivalent of 800 micrograms/d of beclomethasone in adults and 400 micrograms/d in children. If higher doses are used to obtain greater clinical benefit, the answers to these questions may determine the place of new inhaled corticosteroids with high local potency and little systemic activity.

Administration, Inhalation↗
PubMed1997

Interpretation of positive results of a methacholine inhalation challenge and 1 week of inhaled bronchodilator use in diagnosing and treating cough-variant asthma.

BACKGROUND: In diagnosing cough due to asthma, methacholine chloride inhalation challenge (MIC) interpreted in a traditional fashion has been shown to have positive predictive values from 60% to 82%. OBJECTIVE: To determine whether any features of positive results of an MIC or the results of a 1-week trial of inhaled beta-agonist therapy were helpful in predicting when the cough was due to asthma. METHODS: The study design was a prospective, randomized, double-blind, placebo-controlled, crossover format performed in adult, nonsmoking subjects, who were referred for diagnosis and treatment of chronic cough. The subjects had no other respiratory complaints or medical conditions for which they were taking medications, the results of baseline spirometry and chest roentgenograms were normal, and the results of MIC were positive. After obtaining baseline data, including MICs on 2 separate days, objective cough counting, and self-assessment of cough severity using a visual analog scale, subjects were randomized to receive 2 inhalations (1.3 mg) of metaproterenol sulfate or placebo by metered dose inhaler attached to a spacer device every 4 hours while awake. At 1 week, data identical to baseline were collected, and subjects received the other metered dose inhaler for 7 days. At 1 week, data identical to baseline were collected. After completion of the protocol, subjects were followed up in the clinic to observe the final response of the cough to specific therapy. RESULTS: Based on the disappearance of the cough with specific therapy, the cough was due to asthma in 9 of 15 subjects and nonasthma in 6 of 15 subjects. Baseline data were similar between groups. With respect to MICs, there were no significant differences between groups in the cumulative dose of methacholine that provoked a 20% decrease in forced expiratory volume in 1 second from the postsaline baseline value (PD20 values), slopes of dose-response curves, and maximal-response plateaus. Cough severity significantly improved after 1 week of metaproterenol use compared with the severity of the cough at baseline (P = .03) and with placebo (P = .02) only in subjects with asthma. CONCLUSIONS: No matter how the results are analyzed, positive MIC results, without observing response to therapy, are only consistent with asthma as the cause of the cough. The results are only diagnostic of asthma when they are followed by a favorable response to asthma therapy. After 1 week of inhaled beta-agonist, only the cough due to cough-variant asthma is significantly better.

Administration, Inhalation↗
PubMed1995

Dry-powder inhalers: evaluation of testing methodology and effect of inhaler design.

We have previously developed a spray dried formulation of a model protein (beta-galactosidase) of a size suitable for evaluation in dry powder inhaler devices. In this study, we wished to evaluate the roles of various methods available for the laboratory testing of dry powders for inhalation (cascade impactor, twin impinger, aerodynamic time of flight and image analysis). Secondly we wished to compare different inhaler devices using formulations with and without a carrier. Both the cascade impactor and twin impinger were appropriate methods for the testing of dry powder inhalers, and gave comparable estimates of respirable fraction. Image analysis and aerodynamic time of flight were suitable methods for determining the particle size of the dry powders, although the former was considerably more time consuming than the latter. The four inhalers evaluated differed greatly in terms of in vitro deposition properties. The presence of a carrier significantly improved respirable fraction with the poorer inhalers, but was less critical to the performance of the more efficient devices.

Equipment Design↗
PubMed1996

Efficacy and safety of inhaled bitolterol mesylate via metered-dose inhaler in children with asthma.

BACKGROUND: There have been numerous studies in asthmatic adults demonstrating the efficacy and safety of bitolterol mesylate metered-dose inhaler; however, only one additional study has examined bitolterol metered-dose inhaler in pediatric asthma. OBJECTIVE: To establish the safety and effectiveness of bitolterol mesylate metered-dose inhaler at one, two, and three inhalations in pediatric asthmatic patients 4 to 12 years of age. METHODS: A multicenter, double-blind, randomized, crossover, placebo-controlled, dose-ranging study. Forty-six patients were evaluated in three centers. Patients were stratified by age, 4 to 6, 7 to 9, 10 to 12 years at each center. One, two, or three inhalations were administered along with an additional double-blind, randomized, placebo dose. Bronchodilation was defined as a 15% or greater increase in FEV1 over baseline. Onset, maximum improvement, and duration of action were obtained for each patient. Serial pulse rate, blood pressure, and respiratory rate determinations were obtained for each patient. RESULTS: Onset within five minutes occurred in 56.6% to 71% of patients, depending on the dose. Mean maximum improvement, which was dose dependent, overall ranged from 28.2% to 40.3% with a peak response in 66.7 to 69.8 minutes. In direct relationship of magnitude with regard to dose of bitolterol was observed, (P < .001). A significant correlation, r = .732, in response between bronchodilation and baseline FEV1 was observed (P < .001). Median duration of action ranged from three to four hours in responding patients across all doses. Up to 31% of patients had durations greater than eight hours after three inhalations. Adverse effects were reported in five of 46 patients for all doses with mild transient tremor occurring in two patients, 4.3%. Also, there was little effect on pulse rate, 2.2%. CONCLUSION: Bitolterol is an effective bronchodilator with durations of activity up to eight hours and minimal adverse effects in children.

Administration, Intranasal↗
PubMed1997

Teaching elderly patients how to use inhalers. A study to evaluate an education programme on inhaler technique, for elderly patients.

Elderly patients often receive little or no teaching on the use of their inhalers. This study evaluated a patient teaching programme, designed specifically for elderly people. The sample (n = 27) was taken from patients who were prescribed inhalers and had been admitted to the elderly care wards of an acute provider unit. Individual inhaler technique was assessed, using a simple checklist, both before and after teaching and total scores calculated. Each subject received one to one teaching sessions by a registered nurse on four consecutive occasions that inhaled medication was due, together with an information sheet on inhaler technique. Total scores showed significant improvement; however, improvement on any one action was not found to be significant. Thus patient teaching leads to a significant improvement in inhaler technique; however, further research is necessary to determine whether this improvement is sustained over time. Recommendations for practice are made.

Aged↗
PubMed1986

Errors in inhalation technique and efficiency in inhaler use in asthmatic children.

256 asthmatic children receiving regular inhalation therapy demonstrated how they used their inhalers. Pulmonary function measurements (PFM) were made before and after the demonstrations, and errors in technique were recorded. 242 children had reversible airway obstruction on the day of study. In only 109 (45%) did the inhalation result in an increase in FEV1 greater than or equal to 15% (efficient technique). An efficient inhalation technique was found in 46% of children who demonstrated a pressurized aerosol, 59% who demonstrated a tube spacer aerosol and 46% who demonstrated a rotahaler, and the frequency of efficient technique varied from 17% to 84% between six different groups of instructors. 87% of children controlled and 25% not controlled with PFM at the time of prescription had an efficient technique. Children under 6 years had a more inefficient and a more faulty technique than older children, but otherwise age did not influence the result. Neither was time since instruction of any importance for efficiency or number of errors. The errors recorded that seem to influence efficiency most were: coordination problems, rapid inspirations, ceasing to inspire when the aerosol was fired, and inhalation through the nose. The results emphasize the paramount importance of clear instructions and control of inhalation technique at the time the treatment is prescribed.

Adolescent↗
PubMed1985

A comparison of flunisolide inhaler and beclomethasone dipropionate inhaler in bronchial asthma.

Ninety-nine patients, who had never previously taken inhaled steroids were enrolled in a randomized, single-blind, parallel study, the aim of which was to compare the efficacy and safety of flunisolide inhalation, 500 mcg twice daily, with beclomethasone dipropionate inhaler 100 mcg four times daily for the treatment of chronic asthma. The treatment period was for 6 weeks. The patients were examined clinically at entry, week 3 and week 6 and both treatment groups showed a marked improvement in almost all parameters during the course of the study. Flunisolide was statistically significantly superior to beclomethasone dipropionate for wheezing at week 6, coughing at week 6 and chest tightness at weeks 3 and 6. The number of asthma attacks per day decreased significantly more with flunisolide treatment than with beclomethasone dipropionate. The over-all evaluation of efficacy by both doctors and patients also showed flunisolide to be superior to beclomethasone dipropionate. In several other parameters there was a trend shown favouring flunisolide, and beclomethasone dipropionate did not show a superiority over flunisolide in any efficacy parameter. Both drugs were well-tolerated, with unpleasant taste being the most frequent complaint in the flunisolide group. No patient in either group withdrew from the study because of adverse events. In this study, flunisolide inhaler was more effective than beclomethasone dipropionate inhaler for the treatment of chronic asthma exhibited by patients who had never been treated with inhaled steroids.

Adolescent↗
PubMed1999

Once-daily inhaled corticosteroids in children with asthma: dry powder inhalers.

The cornerstone of pharmacological management of asthma in childhood is inhaled corticosteroids. These drugs are intended for long term treatment and, consequently, compliance is a major issue. Once-daily administration of maintenance medication would simplify treatment and it is likely that it would lead to better compliance. Moreover, the excellent safety profile of inhaled corticosteroid treatment tailored to disease severity may, theoretically, be further improved with once-daily administration. Studies comparing inhaled corticosteroids given once or twice daily to patients with asthma indicate that unstable asthma is best treated with at least 2 daily doses. On the other hand, it has been demonstrated that, if the asthma is stabilised, most children can be treated with inhaled corticosteroids once daily without loss of efficacy. Thus, the data suggest that newly diagnosed asthma, or asthma after deterioration, should first be reliably controlled with inhaled corticosteroids divided into at least 2 daily doses. Once-daily maintenance treatment should then be tried with the aim of improving compliance and quality of life. A dry powder inhalation device is probably the best choice for children from the age of 5 years.

Adrenal Cortex Hormones↗