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Fast onset of effect of budesonide/formoterol versus salmeterol/fluticasone and salbutamol in patients with chronic obstructive pulmonary disease and reversible airway obstruction
Author(s) -
LINDBERG Anne,
SZALAI Zsuzsanna,
PULLERITS Teet,
RADECZKY Eva
Publication year - 2007
Publication title -
respirology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.857
H-Index - 85
eISSN - 1440-1843
pISSN - 1323-7799
DOI - 10.1111/j.1440-1843.2007.01132.x
Subject(s) - formoterol , medicine , salbutamol , salmeterol , fluticasone , budesonide , copd , placebo , budesonide/formoterol , anesthesia , bronchodilator , formoterol fumarate , onset of action , fluticasone propionate , bronchodilatation , inhalation , asthma , crossover study , bronchodilation , alternative medicine , pathology
Background and objectives: Data on the onset of action of COPD medications are lacking. This study compared the onset of bronchodilation following different inhaled therapies in patients with moderate‐to‐severe COPD and reversible airway obstruction. Methods: In this double‐blind, double‐dummy, crossover study, 90 patients (aged ≥40 years; FEV 1 30–70% predicted) were randomized to a single dose (two inhalations) of budesonide/formoterol 160/4.5 μg, salmeterol/fluticasone 25/250 μg, salbutamol 100 μg or placebo (via pressurized metered‐dose inhalers) on four visits. The primary end‐point was change in FEV 1 5 min after drug inhalation; secondary end‐points included inspiratory capacity (IC) and perception of onset of effect. Results: Budesonide/formoterol significantly improved FEV 1 at 5 min compared with placebo ( P < 0.0001) and salmeterol/fluticasone ( P = 0.0001). Significant differences were first observed at 3 min. Onset of effect was similar with budesonide/formoterol and salbutamol. Improvements in FEV 1 following active treatments were superior to placebo after 180 min (all P < 0.0001); both combinations were better than salbutamol at maintaining FEV 1 improvements ( P ≤ 0.0001) at 180 min. Active treatments improved IC at 15 and 185 min compared with placebo ( P < 0.0001). Maximal IC was greater with budesonide/formoterol than salmeterol/fluticasone ( P = 0.0184) at 65 min. Patients reported a positive response to the perceptions of the onset of effect question shortly after receiving active treatments (median time to onset 5 min for active treatments vs 20 min for placebo), with no significant difference between active treatments. Conclusion: Budesonide/formoterol has an onset of bronchodilatory effect in patients with COPD and reversible airway obstruction that is faster than salmeterol/fluticasone and similar to salbutamol.