pulmicort and bambuterol

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 /= 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.

Topics: Administration, Inhalation; Administration, Oral; Adolescent; Adrenergic beta-Agonists; Adult; Aged; Albuterol; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Double-Blind Method; Female; Glucocorticoids; Humans; Male; Middle Aged; Peak Expiratory Flow Rate; Salmeterol Xinafoate; Terbutaline

Effects of the inhaled corticosteroid budesonide and the oral beta-agonist bambuterol on the nocturnal worsening of asthma were studied in patients with allergic asthma with a circadian peak expiratory flow variation greater than or equal to 15% (group 1, n = 8) and less than 15% (group 2, n = 9). Airflow limitation and airway responsiveness to histamine were measured during 24 hours after 4 weeks of treatment with (A) 0.4 mg budesonide at 8 AM and 8 PM, (B) 20 mg bambuterol at 8 PM, and (C) placebo, in a randomized, crossover design. Patients in group 1 had worse nocturnal symptom scores and a greater airway responsiveness than patients in group 2; in addition, patients in group 1 had a larger increase in responsiveness during the night (1.1 versus 0.6 doubling concentrations [DC]). Both budesonide and bambuterol improved responsiveness more at night than during daytime, thus decreasing circadian variation: at 4 AM, increases in PC20 were 2.0 DC after budesonide and 0.8 DC after bambuterol, compared with placebo. Bambuterol reduced circadian variation in FEV1, but in contrast to budesonide, did not improve 24-hour mean levels of FEV1 and PC20. Both drugs beneficially influenced nocturnal symptoms; the effects of budesonide were stronger than those of bambuterol. Our findings demonstrate that budesonide and bambuterol reduce nocturnal airway responsiveness and asthma symptoms and suggest a relationship between the degree of airway responsiveness and the presence of nocturnal symptoms of asthma.

Topics: Adolescent; Adrenergic beta-Agonists; Adult; Asthma; Bronchodilator Agents; Budesonide; Circadian Rhythm; Female; Forced Expiratory Volume; Humans; Male; Pregnenediones; Terbutaline

The effects of the inhaled corticosteroid budesonide and the oral long-acting beta-agonist bambuterol on circadian variation of blood eosinophil numbers, serum levels of eosinophil cationic protein (ECP), serum eosinophil chemotactic activity (ECA), and serum neutrophil chemotactic activity (NCA) were studied in two groups of patients with allergic asthma. Group 1 (n = 8) had a circadian variation of peak expiratory flow (PEF) 15% or greater, and group 2 (n = 9) had a circadian PEF variation less than 15%. Both groups were randomized and crossover treated for 4 weeks with (A) 0.4 mg budesonide at 8 AM and 8 PM, (B) 20 mg bambuterol at 8 PM, and (C) placebo. At the end of each period blood eosinophil numbers, ECP, ECA, and NCA were measured during 24 hours at 4-hour intervals. No significant differences in the inflammatory parameters could be observed between the groups, although eosinophil numbers tended to be higher in group 1 than in group 2. Highest eosinophil numbers were observed at night. Budesonide reduced both eosinophil numbers and ECP levels, especially at night; bambuterol had no effect on both variables. No circadian variation or treatment effects were observed for ECA and NCA. This study suggests a role for the eosinophil in the nocturnal worsening of asthma, and it demonstrates that budesonide produces, in contrast to bambuterol, a reduction of (nocturnal) eosinophil numbers and activity.

Topics: Adolescent; Adult; Blood Proteins; Bronchodilator Agents; Budesonide; Chemotactic Factors, Eosinophil; Circadian Rhythm; Eosinophil Granule Proteins; Eosinophils; Female; Humans; Leukocyte Count; Male; Pregnenediones; Ribonucleases; Terbutaline; Time Factors

Topics: Administration, Topical; Anti-Inflammatory Agents; Asthma; Bronchodilator Agents; Budesonide; Circadian Rhythm; Darkness; Glucocorticoids; Humans; Pregnenediones; Prodrugs; Terbutaline

An automated thermospray liquid chromatography-mass spectrometry system is described, including an autosampler and a gradient liquid chromatography system controlled from the mass spectrometer data system. The performance and reliability of the equipment during unattended operation were evaluated by repeated injections of standard solutions of some antiasthmatic drugs, using deuterium-labelled analogues as internal standards. High sensitivity and reproducibility were achieved during a 19-hour run, incorporating gradient elution and a total of 54 injections. The relative standard deviation of the peak area measurement of the internal standards was in the range of 6.5-8.2%. The corticosteroid budesonide can be routinely measured in plasma down to 0.1 nmol/l. Direct injection of a small plasma volume into the thermospray liquid chromatography-mass spectrometry system could be used to monitor drug plasma levels during a toxicity study in dogs.

Topics: Animals; Autoanalysis; Bronchodilator Agents; Budesonide; Chromatography, Liquid; Dogs; Humans; Mass Spectrometry; Pregnenediones; Terbutaline