Drug Res (Stuttg) 2013; 63(06): 305-310
DOI: 10.1055/s-0033-1341433
Original Article
© Georg Thieme Verlag KG Stuttgart · New York

Non-inferiority Trial between Two Dry-powder Inhalers Containing Fluticasone/Salmeterol in Asthmatic Patients

H. A. Serra
1   Pharmacology Department, Faculty of Medicine, UBA, Buenos Aires, ­Argentina
7   Medical Department, Química Montpellier S.A., Buenos Aires, Argentina
F. P. Klapouszko
1   Pharmacology Department, Faculty of Medicine, UBA, Buenos Aires, ­Argentina
4   Hospital T. Alvarez, Buenos Aires, Argentina
7   Medical Department, Química Montpellier S.A., Buenos Aires, Argentina
M. C. De Salvo
2   Hospital E. Tornú, Buenos Aires, Argentina
E. C. Bavasso
3   Hospital B. Sommer, Gral. Rodríguez, Argentina
L. Rey
5   Hospital María Ferrer, Buenos Aires, Argentina
D. Downey
6   Hospital Español de Buenos Aires, Argentina
D. Lopez
4   Hospital T. Alvarez, Buenos Aires, Argentina
J. M. Roganovich
7   Medical Department, Química Montpellier S.A., Buenos Aires, Argentina
L. F. Rizzo
7   Medical Department, Química Montpellier S.A., Buenos Aires, Argentina
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received 07. November 2012

accepted 18. Februar 2013

04. April 2013 (online)


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.

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