Background and Objectives: To investigate the therapeutic equivalence of the two formulations of the glucocorticosteroid budesonide delivered either by the budesonide Novolizer®, i.e. a multidose dry powder inhaler, or by the Pulmicort® Turbuhaler® in asthmatic patients in terms of efficacy, safety and tolerability during a 12-week treatment. Methods: A total of 315 patients were randomised in this open, multicentre study. Inclusion criteria comprised previously diagnosed bronchial asthma of mild to moderate persistent intensity (ranging from 60% to a maximum of 90% predicted FEV1), need for anti-inflammatory therapy, inhalation of β2-sympathomimetics on an as needed to regular basis, reversibility of airway obstruction of >12% after inhalation of 2 actuations of 100 µg salbutamol. Primary variable was FEV1, secondary were other pulmonary function test variables, PC20FEV1 for histamine challenge, morning and evening PEFR, salbutamol usage, asthma symptoms, reactions after inhalation, standard safety variables. Results: The comparison of the FEV1 at study endpoint indicated that the Novolizer® was at least as efficacious as the Turbuhaler® (p < 0.001). All other variables of the pulmonary function tests as well as the asthma symptoms, nocturnal awakenings, PEFR measurements, or salbutamol usage indicated no relevant difference. Only 1 patient (Turbuhaler®) discontinued prematurely due to lack of efficacy. None of the other safety variables (adverse events, laboratory variables, vital signs, etc.) indicated any difference between the groups. Conclusions: The budesonide Novolizer® is therapeutically equivalent to the Pulmicort® Turbuhaler® for the long-term treatment of patients with mild to moderate persistent asthma.