Fluticasone/formoterol combination therapy versus budesonide/formoterol for the treatment of asthma A randomized, controlled, non-inferiority trial of efficacy and safety /
Objectives. The inhaled corticosteroid fluticasone propionate (fluticasone) and the long-acting β2 agonist formoterol fumarate (formoterol) have been combined in a single aerosol inhaler fluticasone/formoterol (flutiform®). This study compared the efficacy and safety of fluticasone/formoterol with t...
Elmentve itt :
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| Dokumentumtípus: | Cikk |
| Megjelent: |
2012
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| Sorozat: | JOURNAL OF ASTHMA
49 No. 10 |
| Tárgyszavak: | |
| doi: | 10.3109/02770903.2012.719253 |
| mtmt: | 3410601 |
| Online Access: | http://publicatio.bibl.u-szeged.hu/29996 |
| Tartalmi kivonat: | Objectives. The inhaled corticosteroid fluticasone propionate (fluticasone) and the long-acting β2 agonist formoterol fumarate (formoterol) have been combined in a single aerosol inhaler fluticasone/formoterol (flutiform®). This study compared the efficacy and safety of fluticasone/formoterol with the combination product budesonide/formoterol (Symbicort® Turbohaler®). Methods. A randomized, double-blind, double-dummy, multicenter, Phase 3 study comprising a 7- (±3) day screening, 2-4-week run-in, and 12-week treatment periods. Patients aged ≥12 years with moderate to severe persistent asthma for ≥6 months before screening and forced expiratory volume in one second (FEV1) 50-80% predicted and ≥15% reversibility following salbutamol inhalation were randomized to fluticasone/formoterol 250/10 μg twice daily (n = 140) or budesonide/formoterol 400/12 μg twice daily (n = 139). Results. Fluticasone/formoterol was comparable to budesonide/formoterol with respect to the primary endpoint, change in pre-dose FEV1 from baseline to Week 12. The LS mean treatment difference was -0.044 L, with a lower 95% confidence interval (CI) greater than the pre-defined non-inferiority limit of -0.2 L (95% CI: -0.130, 0.043 L; p < 0.001). Non-inferiority was also demonstrated for the secondary endpoints mean change in FEV1 from baseline (pre-dose) to 2 hours post-dose at Week 12, and discontinuations due to lack of efficacy. Similar results were obtained for both treatment groups for all other secondary endpoints. Fluticasone/formoterol had a good safety profile that was comparable with budesonide/formoterol. Conclusions. This study demonstrated comparable efficacy of fluticasone/formoterol to budesonide/formoterol in terms of the primary endpoint, change in pre-dose FEV1 from baseline to Week 12. This was supported by comparable results for both treatments for all secondary endpoints. Copyright © 2012 Informa Healthcare USA, Inc. |
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| Terjedelem/Fizikai jellemzők: | 1060-1070 |
| ISSN: | 0277-0903 |