title: Budesonide/salmeterol in fixed-dose combination for the treatment of asthma.
abstract: Fixed dose combinations (FDC) of inhaled corticosteroid (ICS) and long-acting beta agonist (LABA) are well established in asthma treatment. The budesonide/salmeterol (B/S) FDC is now about to reach the market. It is provided as powder in hard capsules of two strengths: 120/20μg and 240/20μg when expressed as delivered doses, equivalent to 150/25μg and 300/25μg when expressed as nominal doses. Its development involved 9 pharmacokinetic (320 subjects), 3 phase II (123 subjects) and 4 phase III (1206 patients with different asthma severity) studies. Delivery is effectuated via low resistance inhaler device, Axahaler®, generating also fine particles targeting the small airways. B/S safety, assessed in 1401 subjects, did not outline novel concerns specific for this FDC. In conclusion, the B/S dry powder FDC can be used for asthma treatment in adults not adequately controlled on ICS alone, or to maintain control of ICS/LABA treated patients, in whom switching to alternative FDC is indicated.
authors.affiliation: a Clinic of Allergy & Asthma , Medical University in Sofia , Sofia , Bulgaria.
authors.forename: Todor A
authors.initials: TA
authors.lastname: Popov
authors.affiliation: b Laboratoires SMB SA , Brussels , Belgium.
authors.forename: Sophie
authors.initials: S
authors.lastname: De Niet
authors.affiliation: b Laboratoires SMB SA , Brussels , Belgium.
authors.forename: Francis
authors.initials: F
authors.lastname: Vanderbist
mesh_terms: D058666:Adrenergic beta-2 Receptor Agonists / Q000008:administration & dosage* / Q000493:pharmacokinetics; D001249:Asthma / Q000188:drug therapy*; D019819:Budesonide / Q000008:administration & dosage* / Q000493:pharmacokinetics; D002986:Clinical Trials as Topic; D004338:Drug Combinations; D004353:Drug Evaluation, Preclinical; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000493:pharmacokinetics; D006801:Humans; D009330:Nebulizers and Vaporizers; D000068299:Salmeterol Xinafoate / Q000008:administration & dosage* / Q000493:pharmacokinetics
chemical_list: D058666:Adrenergic beta-2 Receptor Agonists; D004338:Drug Combinations; D005938:Glucocorticoids; D019819:Budesonide; D000068299:Salmeterol Xinafoate
keywords: Asthma treatment; budesonide; fine particles dose; fixed dose combination; inhaled corticosteroid; inhaler device; long-acting beta-agonist; salmeterol