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Short-term treatment with extended release albuterol may increase lean body mass, decrease fat mass, and improve functional measures in patients with dystrophinopathies. However, the significant change in strength of specific muscle groups found in the pilot study was not observed in the present study. These findings may be attributed to differences in the drug release and kinetics between Repetab and Volmax formulations as they affect the concentration of available beta-2 receptors on the muscle cell surface differently.
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Treatment with salmeterol, 50 micro g bid, does not increase the risk of cardiovascular AEs in this population of COPD patients compared with placebo.
This method was found to be simple, rapid, sensitive and accurate for determination of salbutamol in human plasma.
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Inhalation of a single dose of the long-acting beta 2-adrenoceptor agonist salmeterol protects against methacholine-induced airway obstruction and other bronchoconstricting stimuli for at least 12 hours. Hypothetically, twice daily dosing of salmeterol may result in continuous protection.
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Acute pulmonary injury can occur after a short exposure to an inhaled hydrocarbon and associated symptoms appear to respond to supportive measures, including oxygen, corticosteroids, and bronchodilators.
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Baseline measurements (mean +/- SD) were as follows: FEV1, 1.89 +/- 0.87 L; FVC, 3.02 +/- 0.99 L; respiratory resistance at 5 Hz (Rrs5), 10.3 +/- 3.85 cm H2O . s/L; and mean respiratory resistance at 5 to 20 Hz, 7.56 +/- 1.92 cm H2O/L/s. Mean baseline serum BNP level was 27 +/- 27 pg/mL. After 180 min of nesiritide infusion, the following measurements showed significant changes: FEV1 increased to 2.41 +/- 0.78 L (mean increase, 520 mL), p = 0.012; FVC increased to 3.65 +/- 1.05 L (mean increase, 630 mL), p = 0.017; and Rrs5 decreased to 8.24 +/- 4.02 cm H2O/L/s, p = 0.017. After albuterol, there were no further significant changes in these measurements.
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We examined 63 subjects with COPD (mean age: 71.7 years). Reversibility was measured by the change in FEV1 and FVC after the inhalation of salbutamol (300 microg), and we investigated the relationship between the reversibility and the parameters of HRQoL, which included St. George's Respiratory Questionnaire (SGRQ), Visual analogue scale-8 (VAS-8), Short-Form 36-Item Health Study, Basic activities of daily living, Instrumental activities of daily living, and the Oxygen cost diagram.
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A dose-ranging study was conducted to evaluate the efficacy and safety of a new long-acting, selective beta 2-adrenoceptor agonist, salmeterol.
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The relative systemic availabilities of budesonide and fluticasone between patients with severe COPD and healthy subjects were similar. In patients with COPD, a larger fraction of fluticasone was expectorated in the sputum as compared with budesonide.
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Asthma is an inflammatory disease involving the airways. E-series prostaglandins have potent anti-inflammatory effects on neutrophils and T lymphocytes. Accordingly, we tested the acute (i.e., 6 h) and chronic (i.e., 1 week) effects of oral misoprostol 200 &mgr;g in five stable asthmatics. A double-blind, randomized, crossover design was used. Airway function was assessed from measurements of forced expiratory volume in 1 s (FEV(1)). The number of puffs of the inhaled beta-adrenergic agonist bronchodilator, albuterol, taken for symptomatic rescue, was assessed by diary. FEV(1) measured serially for 6 h after 200 &mgr;g misoprostol was similar on misoprostol and placebo days in all subjects. In contrast, three of the five subjects showed appreciable increases in FEV(1) during a week of misoprostol compared to either baseline or placebo week. Two subjects showed no change in the FEV(1) with 1 week of misoprostol. All three of the subjects who kept a diary decreased the number of puffs of albuterol during the misoprostol compared to placebo period. Of note, in these three subjects, airway function improved (n = 1) or remained the same (n = 2) despite a diminution in the number of puffs of a beta-agonist administered. None of the subjects administered the 200-&mgr;g oral dose QID reported any significant symptoms or adverse reaction. In conclusion, several inferences can be drawn from this early preliminary study. These data suggest that a trial involving a large number of subjects, a longer period of treatment, and a more objective method of assessing inhaler use may be useful in evaluating the chronic effects of misoprostol in asthma.
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One hundred twenty patients were randomized. The groups were comparable in terms of age, gender, asthma severity, previous treatments, and use of inhaled steroids. There was no significant difference between treatments in the change in PIS, length of stay, admission to hospital, or relapse rate. The epinephrine-treated group had significantly more minor side effects (such as excess or brownish nasal discharge).
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Inhaled formoterol is a long-acting selective beta2-adrenoceptor agonist, with an onset of action of 5 minutes postdose and a bronchodilator effect that lasts for at least 12 hours. Statistically significant and clinically relevant (>120 ml) improvements in lung function [assessed using standardized/normalized area under the forced expiratory volume in 1 second (FEV1) versus time curve (AUC FEV1)] were observed with inhaled formoterol 12 microg twice daily (the approved dosage in the US) compared with placebo in 12-week and 12-month, randomized, double-blind trials in patients with chronic obstructive pulmonary disease (COPD). The bronchodilator efficacy of formoterol 12 microg twice daily was greater than that of oral slow-release theophylline (individualized dosages) in a 12-month trial or inhaled ipratropium bromide 40 microg four times daily in a 12-week trial. Improvement in AUC FEV1 with formoterol, but not theophylline, compared with placebo was observed in patients with irreversible or poorly-reversible airflow obstruction. Formoterol also significantly improved health-related quality of life compared with ipratropium bromide or placebo and significantly reduced symptoms compared with placebo. Combination therapy with formoterol 12 microg twice daily plus ipratropium bromide 40 microg four times daily was significantly more effective than albuterol (salbutamol) 200 microg four times daily plus the same dosage of ipratropium bromide in a 3-week, randomized, double-blind, double-dummy, crossover trial. Inhaled formoterol was well tolerated in clinical trials. The incidence of investigator-determined drug-related adverse events with inhaled formoterol 12 microg twice daily was similar to that with placebo and inhaled ipratropium bromide 40 microg four times daily but lower than that with oral slow-release theophylline (individualized dosages). Importantly, there were no significant differences between formoterol and placebo or comparator drugs in cardiovascular adverse events in patients with COPD and corrected QT interval values within the normal range. In conclusion, inhaled formoterol improved lung function and health-related quality of life and reduced symptoms relative to placebo in clinical trials in patients with COPD. The drug had greater bronchodilator efficacy than oral slow-release theophylline or inhaled ipratropium bromide and showed efficacy in combination with ipratropium bromide. The adverse events profile (including cardiovascular adverse events) with formoterol was similar to that with placebo. Thus, inhaled formoterol may be considered as a first-line option for the management of bronchoconstriction in patients with COPD who require regular bronchodilator therapy for the management of symptoms.
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This study compared the protection provided by salbutamol and salmeterol against exercise-induced asthma. Asthmatic patients (n = 12) with exercise-induced asthma were exercised submaximally for 6 min on a treadmill 1, 6 and 12 h after inhalation of 200 micrograms salbutamol or 50 micrograms salmeterol. Each patient also took baseline exercise 1 h after two puffs of placebo. Two days later the drugs were administered in a double-blind trial of crossover design with an interval of 48 h between the two treatments. The main parameters measured were: air flow with a Wright flowmeter and mediator concentrations (histamine, leucotriene and prostaglandin D2 measured by radioimmunoassay) in venous blood, which was withdrawn before and 4 min after each exercise period. The maximum percentage bronchoconstriction recorded following placebo was 29 +/- 4% and following salbutamol inhalation it was 4 +/- 4%, 20 +/- 13%, 27 +/- 10%, respectively, for the exercise periods performed 1, 6 and 12 h after inhalation of the drug. Following salmeterol, the corresponding figures were 3 +/- 4%, 3 +/- 3% and 11 +/- 9%. The concentrations of mediator in plasma were significantly increased after exercise. Salbutamol and salmeterol intake reduced these concentrations both when the patients were at rest and following the exercise period. This effect of both drugs on the mediators corresponded with the protection they provided against exercise-induced asthma and was maintained for 12 h after salmeterol inhalation and for 6 h after salbutamol inhalation.
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Twenty-six established asthma investigators, who are part of the National Institutes of Health-supported Inner City Asthma Consortium, participated in a modified Delphi consensus process to identify and weight the dimensions of asthma. Factor analysis was performed to identify independent domains of asthma by using the Asthma Control Evaluation trial. CASI was validated by using the Inner City Anti-IgE Therapy for Asthma trial.