title: Non-inferiority trial between two dry-powder inhalers containing fluticasone/salmeterol in asthmatic patients.
abstract: Asthma is an increasing pathology with poor compliance. Achievement of control is possible but under intensive treatment. In this setting, fluticasone/salmeterol association delivered by dry powder inhalers is a valuable and proved option. A prospective, parallel, open-label, phase IV, multicentre non-inferiority study was conducted to determine therapeutic similarity between 2 different inhalers: Generic DPI and Diskus®, which both deliver a fluticasone/salmeterol association (CAS 80474-14-2/CAS 89365-50-4). A 103 uncontrolled asthmatic patients were randomly assigned in 2 groups, Generic (G) and Diskus® (D), and received the association for 18 weeks through the appropriate device. They were evaluated according to Asthma Quality of Life Questionnaire and GINA/NIH guidelines. To demonstrate non-inferiority, the estimation of the Relative Risk between the Global Score Rate per group with its 95% confidence interval was calculated and compared against a non-inferiority margin obtained from a previous study. The Global Score Rate was 82% for G Group and 83% for D Group. The RR was 1.0124 (95% CI: 0.847-1.210). The margin set at 0.832 was not reached by the lower 95% CI (z=-2.097; p=0.018) pointing out non-inferiority. The results have demonstrated non-inferiority between groups. Thus, the 2 products are therapeutically similar.
authors.affiliation: Pharmacology Department, Faculty of Medicine, UBA, Buenos Aires, Argentina. aserra@montpellier.com.ar
authors.forename: H A
authors.initials: HA
authors.lastname: Serra
authors.forename: F P
authors.initials: FP
authors.lastname: Klapouszko
authors.forename: M C
authors.initials: MC
authors.lastname: De Salvo
authors.forename: E C
authors.initials: EC
authors.lastname: Bavasso
authors.forename: L
authors.initials: L
authors.lastname: Rey
authors.forename: D
authors.initials: D
authors.lastname: Downey
authors.forename: D
authors.initials: D
authors.lastname: Lopez
authors.forename: J M
authors.initials: JM
authors.lastname: Roganovich
authors.forename: L F
authors.initials: LF
authors.lastname: Rizzo
mesh_terms: D000328:Adult; D000420:Albuterol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000730:Androstadienes / Q000008:administration & dosage* / Q000009:adverse effects; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy*; D004338:Drug Combinations; D058995:Dry Powder Inhalers; D005260:Female; D000068297:Fluticasone-Salmeterol Drug Combination; D006801:Humans; D008297:Male; D008875:Middle Aged
chemical_list: D000730:Androstadienes; D018927:Anti-Asthmatic Agents; D004338:Drug Combinations; D000068297:Fluticasone-Salmeterol Drug Combination; D000420:Albuterol