Abstract

BACKGROUND: The study aimed to compare the efficacy and safety of nebulized steroid (NS) with systemic corticosteroids (SC) and to determine optimal NS dose in the treatment of patients with COPD exacerbations requiring hospitalization.

MATERIAL AND METHODS: The study was a randomized, parallel design trial. Eligible patients (n=86) were randomly allocated to 1 of the 3 treatment groups: parenteral corticosteroid (PS) (n=33), 4 mg (NB) (n=27), or 8 mg NB (n=26). Partial pressure of arterial oxygen (PaO2), carbon dioxide (PaCO2), pH, and oxygen saturation (SaO2) were evaluated at baseline, 24 h, 48 h, and discharge. Airway obstruction (forced vital capacity [FVC] and forced expiratory volume 1 s [FEV1]) was evaluated at admission and discharge.

RESULTS: There were no significant differences between the groups for all parameters at all time periods, except for higher FEV1 value in the 8-mg NB group at baseline. In groups, significant differences were determined for FVC, FEV1, PaO2, and SaO2 (p<0.001), but not for PaCO2 and pH, in comparison to their baseline values. As adverse events, hyperglycemia and oral moniliasis were observed in the PS group (n=4) and in the NB groups (n=5), respectively, and treatment change was required in 9 patients (2 patients in the PS group and 7 patients in the NB groups) (p=0.57).

CONCLUSIONS: Nebulized budesonide may be used as an alternative to SC because of its equal effectiveness and lesser systemic adverse effects. The choice of optimal dosage needs to be evaluated carefully because adverse effect and dropout rates varied according to dosage. However, there is a need for further studies including more severe cases and evaluating long-term outcomes or relapses comparing the 3 arms.

Keywords: Administration, Inhalation, Pulmonary Disease, Chronic Obstructive - drug therapy, Disease Progression, Dose-Response Relationship, Drug, Follow-Up Studies, Infusions, Parenteral, Nebulizers and Vaporizers, Oxygen - metabolism, Partial Pressure, Steroids - therapeutic use