Improvement In Peak Expiratory Flow Rate Research Articles

EFFECTIVENESS OF ACUTE ASTHMA CARE AMONG INNER-CITY ADULTS

Coyle YM, Aragaki CC, Hynan LS, Gruchalla RS, Khan DA. Arch Intern Med. 2003;163:1591–1596To identify processes of asthma care that result in improved peak expiratory flow rate (PEFR) 2 to 3 weeks after an emergency department visit.A total of 365 adults with asthma who were discharged from a public hospital emergency department after an asthma exacerbation were studied.Eligible patients were identified from an administrative database and were invited for a follow-up visit 2 to 3 weeks after discharge from the emergency department. Information regarding 6 processes of care was obtained from emergency department records and questionnaires. These processes of care were 1) inhaled β-receptor agonist at discharge, 2) inhaled corticosteroids at discharge, 3) systemic corticosteroids, 4) a follow-up visit, 5) patient education regarding an inhaler device, and 6) patient education regarding asthma medication use. Each process was examined as a potential predictor of percentage changes in predicted PEFR.Three hundred sixty-five of 448 eligible patients enrolled in the study, and 309 returned for the follow-up visit. The study population was economically disadvantaged and predominantly African American and Hispanic. The range of percentage PEFR changes was −165% to 590%, with a median of 80%. Male subjects had significantly greater percentage PEFR changes than did female subjects (115% vs 74%, P = .002), and patients with mild asthma had significantly greater percentage PEFR changes than did those with moderate or severe asthma (148% vs 87% and 22%, respectively; P < .001). After adjustment for gender, ethnicity, and asthma severity, appropriate use of systemic corticosteroids at discharge was associated with a 31.6% increase in the predicted PEFR (95% confidence interval: 8.1–55.1%). Asthma severity did not modify the effect of systemic corticosteroids on percentage changes in PEFR.These findings suggested that, among poor minority adults with asthma, systemically administered corticosteroids improved PEFR 2 to 3 weeks after discharge from an emergency department.Although the results were not surprising, this study demonstrated that at least 1 aspect of acute asthma care might have improved outcomes in a high-risk patient population. Whether the improvements in PEFR seen a few weeks after discharge represent markers for improved asthma outcomes in the longer term remains to be determined.

The Position of Pranlukast, a Cysteinyl Leukotriene Receptor Antagonist, in the Long-Term Treatment of Asthma

Background: Adverse effects, tachyphylaxis, and the position of pranlukast, a cysteinyl leukotriene receptor antagonist, in asthma treatment have not been fully established. Objectives and Methods: To address these questions, adverse effects and long-term efficacy of pranlukast were evaluated in 82 patients [28 patients with moderate asthma (group I), 27 with severe persistent asthma not on oral corticosteroid (OCS; group II) and 27 with severe persistent asthma on OCS (group III)] at 4 and 16 weeks. In the following, pranlukast was either withdrawn 1 year after the start of therapy, or if that was not possible due to reappearance of symptoms, the dose of OCS or inhaled corticosteroid (ICS) was reduced. The efficacy of pranlukast was evaluated during 5 years by peak expiratory flow rate (PEFR), and symptom and treatment scores. Results: Adverse reactions appeared in 4 patients (4.9%; diarrhea, dizziness and leg edema). The mean improvement in PEFR on week 16 was 18.5 ± 2.3, 18.8 ± 3.2, and 15.2 ± 3.8% in groups I–III, respectively (p < 0.01, for all groups). However, increases in PEFR in 29 of 72 patients (40.3%) were less than 15%. Pranlukast could not be withdrawn in 28 of 42 responders (66.7%), but their dose of ICS was reduced by 363 ± 97 µg/day (group II) and that of OCS by 3.4 ± 0.7 mg/day (group III). Tachyphylaxis was not recognized during the 5-year period. Conclusion: Pranlukast is safe when taken for up to 5 years, and is effective irrespective of asthma severity. In the majority of patients with persistent asthma, pranlukast may help to control the disease in the long term.

Reactive Airways Dysfunction Syndrome in Housewives Due to a Bleach–Hydrochloric Acid Mixture

The sudden onset of asthmalike symptoms and persistence of airway reactivity following an acute exposure to an irritant gas or vapor has been termed reactive airways dysfunction syndrome (RADS). A mixture of sodium hypochlorite (bleach, 40%) and hydrochloric acid (18%) is commonly used as a household cleaning solution in our region. From this mixture, chlorine gas is produced, which can cause airway damage and ensuing RADS. Here we describe findings of patients with RADS due to this cleaning mixture, and determine factors associated with a favorable outcome. Data were collected retrospectively on 55 symptomatic patients presenting to our emergency department after inhalation exposure to a mixture of bleach and hydrochloric acid. Symptoms, past medical and smoking history, details of the exposure, initial peak expiratory flow rate (PEFR) and oxygenation, and acute reversibility of airways obstruction were documented. All patients met previously defined criteria for the diagnosis of RADS, but did not undergo methacholine challenge testing and bronchoalveolar lavage or histopathologic study. Fifty patients were followed over the course of 3 mo. The majority of exposures (64%) occurred in the bathroom or kitchen. Only 21 of 55 (38%) patients showed an improvement in PEFR of 15% or greater following two β2-agonist inhalation treatments. In follow-up, 48 patients (87%) improved clinically and functionally (FEV1). Seven patients (13%) deteriorated, with ARDS developing in two, one of whom died from respiratory failure. Advanced age, initial low PEFR, exposure in a small enclosed area, use immediately after mixing, and prolonged short- and long-term exposures were associated with a poorer prognosis. This descriptive study is the largest case series in the literature of RADS developing after exposure to a bleach–hydrochloric acid mixture. The optimum acute treatment and long-term outcomes for patients with RADS due to this combination still need to be determined.

Correlation Between Cysteinyl Leukotriene Release from Leukocytes and Clinical Response to a Leukotriene Inhibitor

Antileukotriene drugs are widely used in patients with bronchial asthma, but not all patients show significant clinical improvements, and no factors have been identified that are correlated with the clinical response to these drugs. This study was designed to examine the factors correlated with a response to a leukotriene receptor antagonist, pranlukast, in patients with asthma. WBC counts, IgE, and ex vivo leukotriene release from leukocytes were measured, and 31 patients with asthma were treated with pranlukast, a leukotriene receptor antagonist, for 4 weeks. Outcome measurements included twice-daily peak expiratory flow rate (PEFR), daytime and nocturnal symptoms, and frequency of beta(2)-agonist use. Subjects with a reduction of > 20% in symptom scores or beta(2)-agonist use, or an improvement of PEFR of > 10% were designated as responders; others were designated as nonresponders. Logistic regression analysis assessed the efficacy of models using various allergic markers correlated with the response to pranlukast. There were 16 responders and 15 nonresponders. The release of cysteinyl leukotrienes from the leukocytes of the responders was higher than that of the nonresponders (p < 0.05). There was a significant correlation between the clinical response and the release of cysteinyl leukotrienes, but not demographic features, WBC counts, percentage of eosinophils, or serum IgE levels (p < 0.05). Subjects with a release of cysteinyl leukotrienes of > 3,500 pg/mL were 11.0 times more likely to respond to pranlukast than those with < 3,500 pg/mL (95% confidence interval, 2.0 to 60.5). Cysteinyl leukotriene release from leukocytes is correlated with leukotriene receptor antagonist response.

Efficacy of budesonide in inhaled corticosteroid—naive patients and patients with mild persistent asthma

Background: Patients with mild intermittent or mild persistent asthma represent 70% of asthma sufferers. Inhaled corticosteroids (ICSs) are the mainstay of treatment for persistent asthma, although many of the early clinical studies of these drugs included only patients with moderate to severe asthma.Objective: This article reviews the literature on the efficacy of budesonide in the treatment of mild persistent asthma, including newly diagnosed ICS-naive patients.Methods: Published data were identified by a MEDLINE search of the English-language literature from 1992 to 2002 using the terms budesonide plus efficacy or safety, both with and without the terms fluticasone or beclomethasone. An AstraZeneca reference database was also used to identify publications from the same period. Controlled, randomized studies that included patients with mild persistent asthma and early-treatment intervention were selected for inclusion.Results: Inhaled budesonide has been used for almost 20 years in the treatment and control of moderate to severe asthma. Studies involving patients with mild persistent asthma have demonstrated significant improvements in peak expiratory flow (PEF) rates (P < 0.01) and forced expiratory volume in I second (P < 0.016) values for adult, adolescent, and pediatric patients treated with budesonide compared with placebo. Budesonide therapy is effective when given once or twice daily via dry powder inhaler or nebulizer, even at a low starting dose (200 μg/d). No significant adverse events have been reported with budesonide within the dose range used to treat mild persistent asthma (200 to 400 μg/d). Significant improvements in PEF rates (P < 0.01) and significant reductions in the risk of exacerbations and the number of days with poorly controlled asthma have been reported for ICS-naive patients treated with budesonide compared with placebo (both P < 0.001). In the primary care setting, mild persistent asthma may be undertreated. Patients with mild persistent asthma benefit significantly from early treatment with budesonide (P < 0.05).Conclusions: Budesonide is effective and well tolerated in the treatment of mild persistent asthma in adults and children, including many patients whose primary care physicians do not think they require daily ICS treatment.

Comparing the immediate Bronchodilatory effects of Salbutamol versus Formoterol: A General Practice Study in Patients with Moderate Asthma

Objectives To determine whether there is significant difference in the onset of bronchodilatory action between salbutamol, a short-acting beta-2 stimulant and formoterol, a long-acting beta-2 stimulant. Background Current guidelines for the management of moderate asthmatics include the regular use' of inhaled corticosteroids in combination with long-acting beta-2 receptor stimulants. In such cases, short-acting beta-2 stimulants like salbutamol are used as rescue medication for sudden episodes of bronchoconstriction. lf, however, the bron-chodilatory effect of formoterol (long-acting) is comparable to that of salbutamol five minutes after administration, the question arises whether additional short-acting bronchodilators should be prescribed for such patients. Peak expiratory flow rate (PEFR) was measured before inhalation of the drug and repeated after exactly five minutes.The results before and after ihhalation,as well as the average results of each group were compared. Methods A randomized, double blind controlled trial was conducted in a private family practice and included 20 patients with moderate asthma, randomly allocated to either the salbutamol or the formoterol group. Results Both formoterol and salbutamol improved the PEFR significantly, exactly five minutes after inhalation. In comparing the two drugs; there were no significant differences in PEFR improvement between the two groups. Conclusions Thel bronchodilatory action of for moterol five minutes after inhalation is comparable to that of salbutamol. Both are very effective bronchodilators, even at low therapeutic doses. The quick onset of action of formoterol makes it unnecessary for patients using this drug to carry additional beta-Z stimulants as rescue medication.The major disadvantage of formoterol is the cost of the medication.

The bronchodilator effect of intravenous glucagon in asthma exacerbation: A randomized, controlled trial

Study Objective: Glucagon is a rapid-acting smooth muscle relaxant with a short half-life. Previous studies suggested glucagon may have bronchodilator effects. We sought to determine whether intravenous glucagon produces clinically important immediate bronchodilation in emergency department patients with asthma exacerbation. Methods: We conducted a randomized, double-blind, placebo-controlled study at 2 university-affiliated community teaching hospital EDs (annual census 90,000). ED patients 18 to 50 years old with asthma exacerbation and peak expiratory flow rate (PEFR) less than 350 L/min were eligible. Exclusion criteria were need for intubation, chronic obstructive pulmonary disease, diabetes mellitus, insulinoma, pheochromocytoma, pregnancy, lactation, or current oral steroid treatment. Patients were randomly assigned to receive glucagon 0.03 mg/kg or an equivalent volume of saline solution intravenously. At 10 minutes, PEFR was measured and all patients began standardized albuterol therapy. Successful bronchodilation was a PEFR increase of 60 L/min at 10 minutes. Results: Success occurred in 2 (9.5%) of 21 glucagon-treated patients and 3 (12%) of 25 placebo-treated patients (95% confidence interval [CI] for difference of –2.5% [–20.4% to 15.4%]). Mean PEFR improvement for glucagon was 2 L/min versus 9 L/min for placebo (95% CI for difference of –7 L/min [–36 L/min to 23 L/min]). Conclusion: Glucagon alone provided no clinically important immediate bronchodilation in ED patients with asthma exacerbation. [Wilber ST, Wilson JE, Blanda M, Gerson LW, Meerbaum SO, Janas G. The bronchodilator effect of intravenous glucagon in asthma exacerbation: a randomized, controlled trial. Ann Emerg Med. November 2000;36:427-431.]

Sudden-onset asthma exacerbations: clinical features, response to therapy, and 2-week follow-up. Multicenter Airway Research Collaboration (MARC) investigators.

Sudden-onset asthma exacerbations may have different triggers and responses to treatment than slower-onset exacerbations. The authors studied this hypothesis among patients with severe asthma exacerbations. The Multicenter Airway Research Collaboration prospectively enrolled patients presenting to 64 North American emergency departments with asthma exacerbations. Of 1,847 patients aged 18-54 yrs, 900 had severe exacerbations (peak expiratory flow rate (PEFR) <50% predicted or hospitalized without PEFR). These patients were divided into sudden-onset (< or =3 h of symptoms) and slower-onset (>3 h of symptoms) groups. Fourteen per cent (95% confidence interval, 11-16%) of patients with severe asthma exacerbations had sudden-onset exacerbations. Sudden-onset patients were similar to slower-onset patients, except triggers of their exacerbations were more often respiratory allergens, exercise or psychosocial stress and less often respiratory infections. Sudden-onset patients were more likely to have used oral beta-agonists and salmeterol in the preceding 4 weeks. Although initial PEFRs and management were similar, sudden-onset patients had a greater improvement in PEFR (35 versus 28% p<0.001). Sudden-onset patients were less often discharged on systemic corticosteroids, but had similar 2-week relapse rates compared with slower-onset patients. Among patients presenting with severe asthma exacerbations, sudden-onset exacerbations had a different pattern of triggers and greater improvement with treatment than slower-onset exacerbations.

Effect of Continuously Nebulized Ipratropium Bromide Plus Albuterol on Emergency Department Length of Stay and Hospital Admission Rates in Patients With Acute Bronchospasm: A Randomized, Controlled Trial

To compare the outcome of patients with acute bronchospasm treated with continuously nebulized albuterol plus ipratropium bromide vs albuterol alone. The Emergency Department (ED) at the University of California San Francisco Medical Center. Patients > or = 18 years old presenting to the ED with acute bronchospasm and a peak expiratory flow rate (PEFR) of < 70% predicted. This was a prospective, randomized, double-blind, placebo-controlled trial. Subjects were treated with either a combination of albuterol (10 mg/h) plus ipratropium bromide (1.0 mg/h) or albuterol alone via continuous nebulization for a maximum of 3 h. Vital signs, Borg dyspnea score, and PEFR were recorded hourly. Primary outcome measures were improvement in PEFR, hospital admission rates, and length of stay in the ED. Data was analyzed for 67 subjects. The mean age (-/+ SD) was 47.5+/-18.8, and mean initial PEFR was 44.8+/-12.5% of predicted. The median length of stay for all subjects was 225 min, and 31% of all subjects were admitted. Patients given combination therapy averaged 6.3% greater improvement in PEFR compared with control subjects (95% confidence interval [CI], -15% to 27%. The odds ratio for admission with combination therapy was 0.88 (95% CI, 0.28 to 2.8). The median length of stay in the ED was 35 min shorter for those receiving combination treatment (210 vs 245 min; p = 0.03). However, when adjusted for initial PEFR, there was no statistically significant difference (p = 0.26). Although the direction of all three outcome measures favored combination therapy, there was no statistically significant difference between ED patients with acute bronchospasm receiving continuous albuterol plus ipratropium bromide and those receiving albuterol alone.

Exhaled carbon monoxide levels during treatment of acute asthma.

Carbon monoxide is known to be present in measurable quantities in the exhaled air of normal subjects and at higher concentrations in asthmatic patients not treated with glucocorticoids. To examine whether exhaled CO is useful in monitoring asthma control, time course changes in peak expiratory flow rate (PEFR) and exhaled CO concentration before and after treatment of acute asthma exacerbations were measured in 20 asthmatic patients. Exhaled CO was measured in triplicate by a portable CO analyser. Exhaled CO was reproducible at all time points. Asthma exacerbations caused a fall in PEFR and a rise in exhaled CO (towards an average of 3.3 parts per million (ppm)) in all patients, and treatment with oral glucocorticoids reversed these changes in both parameters. An improvement of PEFR was closely associated with a reduction of exhaled CO (to an average of 1.5 ppm) after treatment. The maximal exhaled CO concentration significantly correlated with recovery time of PEFR after treatment with oral glucocorticoids (p<0.01). The present study suggests that exhaled CO may be a useful noninvasive means of monitoring the control of asthma.

Use of Heliox-Driven Nebulizer Therapy in the Treatment of Acute Asthma

Study objective: To compare the effectiveness of a helium-oxygen mixture with that of oxygen alone as an aerosolizing gas for β-agonist therapy in patients with mild to moderate exacerbation of asthma. Methods: A prospective, single-blinded study was performed in an urban teaching hospital over a period of 5 months. A convenience sample of 205 patients with mild to moderate exacerbation of asthma were enrolled. The participants were randomly assigned to 1 of 2 groups. The first group received 3 doses of albuterol, 5.0 mg aerosolized in 10 L/min of oxygen, 15 minutes apart. The second group received 3 doses of albuterol, 5.0 mg aerosolized in 10 L/min of a 70:30 helium-oxygen mixture (heliox), 15 minutes apart. Peak expiratory flow rate (PEFR), forced vital capacity (FVC), and forced expiratory volume in 1 second (FEV 1 ) were measured before and after each treatment. Only PEFR and FEV 1 were used in data analysis. Results: Although both the heliox and the oxygen group showed significant improvement in PEFR from baseline after 45 minutes (72% and 70%, respectively), the difference between the 2 groups was clinically and statistically insignificant ( P =.56). Similar findings were observed for FEV 1 . There was no difference in rate of admission or rate of complications between the 2 groups. Conclusion: Despite its ability to decrease the turbulent flow in airways and to reach distal pulmonary tissues, heliox had no clinically significant advantage over standard therapy in the treatment of mild to moderate asthma. Further large-scale studies are necessary to determine the clinical efficacy of heliox in this setting. [Henderson SO, Acharya P, Kilaghbian T, Perez J, Korn CS, Chan LS: Use of heliox-driven nebulizer therapy in the treatment of acute asthma. Ann Emerg Med February 1999;33:141-146.]

Cost Effectiveness of Fluticasone and Budesonide in Patients with Moderate Asthma

The objective of this study was to assess the relative cost effectiveness of fluticasone via metered dose inhaler and budesonide via Turbuhaler((R)) in corticosteroid-naive patients with moderate asthma from a third-party payer perspective (German Sickness Funds). A retrospective economic assessment of direct medication costs of treatment was performed on data from a prospective, randomised, parallel group, 6-week clinical trial. 457 corticosteroid-naive patients between the ages of 18 and 70 years with moderate asthma were included in the intention-to-treat analysis. The fluticasone group had a higher proportion of successfully treated patients (those with a peak expiratory flow rate improvement of >/=10%) [47 vs 42%], a higher average proportion of symptom-free days (40 vs 34%) and lower direct healthcare costs [1997 Deutschmarks (DM)] per day (DM4.23 vs DM5.19) than the budesonide group. Therefore, the daily costs per successfully treated patient (DM9.00 vs DM12.36) and the cost per symptom-free day (DM10.58 vs DM15.26) were both lower with fluticasone than with budesonide. Sensitivity analysis demonstrated that these results were relatively robust over a wide range of plausible assumptions. These results showed that from the perspective of a third-party payer, fluticasone was more cost effective than budesonide over the 6-week study period.

Efficacy and Cost Benefit of Inhaled Corticosteroids in Patients Considered to Have Mild Asthma in Primary Care Practice

OBJECTIVE:Inhaled corticosteroids are infrequently used as asthma therapy in patients considered to have mild asthma in primary care practice. The purpose of this study was to determine whether the use of low doses of inhaled corticosteroids (budesonide), supplemented with bronchodilators as needed, provides clinical benefit and is cost beneficial compared with therapy with bronchodilators alone, in patients considered by their physicians in a primary care setting to have mild asthma, not requiring inhaled corticosteroids.DESIGN:Double-blind, randomized controlled study comparing three parallel treatment groups receiving 400 mg or 800 mg inhaled budesonide/day or placebo.SETTING:Seven primary care practices across Canada.PATIENTS:Fifty-seven adult asthmatics considered to have mild asthma not needing inhaled corticosteroids.OUTCOME MEASURES:Patients recorded morning and evening peak expiratory flow rates (PEFR) and daily asthma symptom scores. Economic data were collected regarding drug and service use and willingness to pay.RESULTS:Budesonide significantly reduced early morning and nocturnal symptoms and sputum production, and reduced the use of a bronchodilator compared with placebo. The budesonide groups also showed significant improvements in PEFR, before and after bronchodilator. No differences were found between the two dosages of budesonide; however, the study had insufficient power to detect differences between dosages, had they been present. There was a similar frequency of adverse events in all three treatment groups. The willingness-to-pay assessment found that both doses of budesonide were more cost beneficial than placebo.CONCLUSIONS:These results demonstrate that inhaled budesonide 400 mg/day provides better asthma control and is cost beneficial compared with bronchodilators alone in the management of patients with mild asthma who were not considered to need inhaled corticosteroids in primary care practice.

Long-Term Xanthine Therapy of Asthma: Enprofylline and Theophylline Compared

Enprofylline is a new xanthine derivative that shares theophylline's bronchodilator properties but is free of theophylline's adenosine receptor antagonist activity. We compared the long-term efficacy and tolerability of enprofylline and theophylline given over a 1-year period to adults with asthma.Patients were recruited from 18 centers and 4 countries to participate in a 1-month double-blind comparison of enprofylline or theophylline in the treatment of asthma and were subsequently maintained on a regimen with the assigned medication for a further 11 months. The dosage of each xanthine was incremented from 150 mg twice daily at initiation to 300 and later 450 mg twice daily depending on the patient's tolerance and, in the case of theophylline, the rapidly assayed serum theophylline level. Patients kept a diary in which they recorded peak expiratory flow rate (PEFR) measured morning and evening, asthma symptom score, and the number of beta 2-agonists taken. Spirometry was checked at clinic visits at 3, 6, 9, and 12 months following randomization.Three-hundred forty-eight patients (174 enprofylline, 174 theophylline) participated in the trial. For both drugs there were significant improvements in PEFR and FEV1 during the first month of treatment with no significant difference between drugs (0.25 L for enprofylline vs 0.30 L for theophylline). Similarly, there were no differences in clinical outcome such as asthma exacerbations or beta 2-agonist usage between the two groups over follow-up. However, inhaled steroid dosage was more likely to have been incremented in theophylline-treated than enprofylline-treated patients (18% vs 8%, p = 0.025). Both drugs produced a modest increase in heart rate throughout the trial (approximately 5 beats/min). In 31 patients (26 enprofylline, 5 theophylline), asymptomatic elevations in aspartate aminotransferase and/or alanine aminotransferase occurred at least once during the study. In five patients (four enprofylline, one theophylline), the increase exceeded three times the upper limit of the normal range. In some subjects receiving enprofylline, serum enprofylline levels rose progressively despite constant oral dosage of the drug.Long-term xanthine therapy is well-tolerated by most adult asthmatics. However, long-term enprofylline administration may be associated with elevation in liver enzyme levels and unpredictable blood levels, thereby limiting its clinical usefulness.

Aminophylline in the Treatment of Acute Asthma When ß2-Adrenergics and Steroids Are Provided

The purpose of this study was to test the contribution of aminophylline in improving peak expiratory flow rate (PEFR) during emergency department treatment of acute asthma when metaproterenol sulfate and steroid therapy are also provided. In a prospective, randomized, double-blind, and placebo-controlled trial at a municipal hospital emergency department, 44 patients with acute asthma, aged 18 to 45 years, with theophylline levels below 28 mumol/L, who had failed to achieve a PEFR of 40% predicted after one nebulized metaproterenol treatment, were recruited. An aminophylline or placebo loading dose and maintenance infusion were administered. All patients received hourly nebulized metaproterenol and initial methylprednisolone sodium succinate. The PEFR was measured hourly for 5 hours. Two-factor repeated-measures analysis of variance of improvement in PEFR ([final-initial PEFR]/predicted PEFR) was assessed. There was no difference in improvement of PEFR at any hour between the treatment and placebo groups. After 5 hours, the difference in improvement ratio was 0.40 (aminophylline) vs 0.36 (placebo) (P = .30; n = 22 in each group). The treatment group suffered more tremor, nausea or vomiting, and palpitations (P < .05). In the emergency department setting, aminophylline contributes no significant improvement in PEFR when beta 2-agonists and corticosteroids are being provided, while causing more side effects.

Inhaled salmeterol in the treatment of patients with moderate to severe reversible obstructive airways disease — a 3-month comparison of the efficacy and safety of twice-daily salmeterol (100 μg) with salmeterol (50 μg)

Three-hundred and fifty patients with moderate to severe reversible obstructive airways disease (forced expiratory volume in 1 s or peak expiratory flow rate < or = 50% predicted, a 15% reversibility to inhaled salbutamol and symptomatic) were recruited into a multi-centre, multinational, double-blind, parallel-group randomized study. Two-hundred and eighty-three patients were randomized to receive 50 micrograms salmeterol twice daily or 100 micrograms salmeterol twice daily administered from a metered-dose inhaler for 3 months. Salbutamol (100 micrograms per metered actuation) was provided for symptomatic relief. Morning and evening peak expiratory flow rate (PEFR), day-time and night-time asthma symptoms and additional bronchodilator usage were recorded by the patient on a daily basis. Lung function and patient/physician assessment of treatment efficacy were recorded at scheduled clinic visits. Safety was determined by monitoring adverse events and standard biochemical, haematological and cardiovascular parameters. Salmeterol 100 micrograms twice daily was consistently superior to salmeterol 50 micrograms twice daily in morning and evening PEFR measurements (mean differences between the treatments: 10-14 l min-1 for morning, 95% CI-0, 22 l min-1, P = 0.047; and 10-15 l min-1 for evening, 95% CI 2, 22 l min-1, P = 0.023). The improvement in PEFR was independent of concurrent steroid usage, with the most marked improvement being seen in the more severe asthmatics requiring concurrent oral corticosteroids (mean differences between the treatments: 27-31 l min-1, 95% CI: 3,55 l m-1, P = 0.027).(ABSTRACT TRUNCATED AT 250 WORDS)

Comparison of Berodual&lt;sup&gt;®&lt;/sup&gt; and Salbutamol in Asthma: A Multicenter Evaluation

A 2-month study was carried out to compare the efficacy and safety of Berodual (B) (Boehringer Ingelheim) and salbutamol (S) in asthma. B is a combined agent with 20 micrograms of ipratropium bromide and 50 micrograms of fenoterol in each metered aerosol puff. Each puff of S contained 100 micrograms of drug. 196 patients were included in the study and received 4 x 2 puffs a day of either B or S. FEV1 and FVC were measured every month, and peak expiratory flow rate (PEFR) 4 times a day, i.e. morning and evening before and after administration of drug. Improvement of PEFR was the same in the two groups. No tachyphylaxis occurred. No difference was observed between the two drugs with regard to heart and respiratory rate, dyspnea and blood pressure. Tremor seemed less frequent with B but this difference was not statistically significant. B achieved the same effects as S though containing less beta-2-agonist agent.

Oxygen saturation as a marker for admission or relapse with acute bronchospasm

Oxygen saturation (SaO 2) as measured by pulse oximetry was evaluated as a means of complementing or supplementing peak expiratory flow rate (PEFR) for early identification of the adult patient needing prolonged therapy for acute bronchospasm. SaO 2 was recorded at baseline and at the time of peak drop after initial bronchodilator therapy for 28 patient visits. PEFR was recorded at baseline and at 15 minutes after initial bronchodilator therapy. Potential admission criteria based on these parameters were compared to patients actually admitted or returned within 72 hours (prematurely discharged). Mean patient age was 36 ± 16.8 years. Mean baseline SaO 2 was 95.4 ± 2.3% (92 to 100%) and SaO 2 at the peak drop after the first bronchodilator therapy was 91.9 ± 3.0% (86 to 97%). Of the criteria evaluated, the following had a significant correlation with admission or premature discharge: baseline PEFR ≤ 100 L/min ( P = .017); PEFR after first bronchodilator therapy ≤ 160 L/min ( P < .0004); the combination of a baseline PEFR ≤ 100 L/min with an improvement in PEFR ≤ 100 L/min ( P < .0003); and the combination of baseline SaO 2 ≤ 95% with an improvement in PEFR ≤ 100 L/min ( P = .0017). As isolated variables, SaO 2 at baseline and SaO 2 at peak drop following bronchodilator therapy were not useful predictors of outcome, although patients severely hypoxemic at presentation were not evaluated.

Microcrystalline theophylline: the relation between oral dose saliva levels, and peak expiratory flow rates in asthma

SummaryIn a double-blind, placebo-controlled study, three groups of adult asthmatic patients with reversible airways obstruction received microcrystalline theophylline in a dosage of 500 mg, 750 mg or 1000 mg daily, in divided doses, over 3 to 5 days. Saliva concentrations of theophylline were correlated with changes in peak expiratory flow rate (PEFR). The results showed there was no significant improvement in PEFR over placebo values in either the 500 mg or 750 mg groups and only at two time points in the 1000 mg group. The 1000 mg dosage study had to be abandoned because of toxic effects. The absence of response was possibly related to the clinical features of the patients studied.