Efficacy and safety of budesonide/formoterol compared with salbutamol in the treatment of acute asthma
Journal
Pulmonary Pharmacology and Therapeutics
Journal Volume
19
Journal Issue
2
Pages
139-147
Date Issued
2006
Author(s)
Abstract
This study compared the efficacy and safety of budesonide/formoterol (Symbicort? Turbuhaler?) with salbutamol pressurized metered-dose inhaler (pMDI) with spacer for relief of acute bronchoconstriction in patients with asthma. In this randomized, double-blind, parallel-group study, patients (n=104 allocated to treatment; n=103 received treatment; mean age 45 years) seeking medical attention for acute asthma (mean FEV1 43% of predicted) received two doses repeated at t=-5 and 0 min of either budesonide/formoterol (320/9 μg, two inhalations) or salbutamol (100 μg×eight inhalations); total doses 1280/36μg and 1600 μg, respectively. All patients received prednisolone 60 mg at 90 min and FEV 1 was assessed over 3 h. FEV1 90 min after dosing (primary variable) increased compared with pre-dose FEV1 by an average of 30% and 32% for budesonide/formoterol and salbutamol, respectively (P=0.66), with similar increases at all timepoints from 3 to 180 min for both groups. Mean pulse rate over 3 h was significantly higher in the salbutamol group versus the budesonide/formoterol group (92 vs. 88 bpm; P<0.01). No treatment differences were seen for other vital signs, including ECG. High-dose budesonide/formoterol was effective and well tolerated for the treatment of acute asthma, with rapid onset of efficacy and a safety profile over 3 h similar to high-dose salbutamol. ? 2005 Elsevier Ltd. All rights reserved.
Subjects
Asthma; Budesonide/formoterol; Reliever medication; Symbicort?
SDGs
Other Subjects
budesonide plus formoterol; prednisolone; salbutamol; adult; aged; article; asthma; bradycardia; breathing rate; clinical trial; controlled clinical trial; controlled study; double blind procedure; drug delivery system; drug efficacy; drug megadose; drug safety; drug tolerability; extrasystole; female; fever; forced expiratory volume; human; hypertension; hypokalemia; major clinical study; male; metered dose inhaler; multicenter study; priority journal; pulse rate; randomized controlled trial; tachycardia; Acute Disease; Administration, Inhalation; Adolescent; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Adult; Aged; Aged, 80 and over; Albuterol; Asthma; Budesonide; Dose-Response Relationship, Drug; Double-Blind Method; Drug Combinations; Electrocardiography; Ethanolamines; Female; Humans; Male; Middle Aged; Respiratory Function Tests
Type
journal article