Corren, Jonathan and Mansfield, Lyndon E. and Pertseva, Tetyana and Blahzko, Viktor and Kaiser, Kirsten (2013) Efficacy and safety of fluticasone/formoterol combination therapy in patients with moderate-to-severe asthma. Respiratory Medicine, V. 107 (Iss.2). pp. 180-195. ISSN 0954-6111
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Abstract
Background: The inhaled corticosteroid, fluticasone propionate, and the long-acting b2-adrenergic agonist, formoterol fumarate, are both highly effective treatments for bronchial asthma. This study (NCT00393952/EudraCT number: 2006-005989-39) compared the efficacy and safety of fluticasone/formoterol combination therapy (flutiform®; 250/10 mg) administered twice daily (b.i.d.) via a single aerosol inhaler, with the individual components (fluticasone 250 mg b.i.d.; formoterol 10 mg b.i.d.), in adult and adolescent patients with moderate-to-severe asthma. Methods: This was a 12-week, double-blind, randomised, parallel-group, multicentre, placebocontrolled phase 3 study. The co-primary efficacy endpoints were: i) the mean change in the forced expiratory volume in the first second (FEV1) from morning pre-dose at baseline to pre-dose at week 12 (fluticasone/formoterol 250/10 mg vs. formoterol), ii) the mean change in FEV1 from morning pre-dose at baseline to 2 h post-dose at week 12 (fluticasone/formoterol 250/10 mg vs. fluticasone), and iii) the number of patients who discontinued prematurely due to lack of treatment efficacy (fluticasone/formoterol 250/10 mg vs. placebo). The secondary endpoints included measures of lung function, disease control, and asthma symptoms. Safety was assessed based on adverse events, vital signs, and clinical laboratory evaluations. Results: Overall, 395 (70.9%) patients completed the study. Fluticasone/formoterol 250/10 mg b.i.d. was superior to the individual components and placebo for all three co-primary endpoints and demonstrated numerically greater improvements for multiple secondary efficacy analyses. Fluticasone/formoterol combination therapy had a good safety profile over the 12 weeks. Conclusion: Fluticasone/formoterol combination therapy will provide clinicians with an efficacious alternative treatment option for patients with moderate-to-severe asthma.
| Item Type: | Article |
|---|---|
| Additional Information: | http://dx.doi.org/10.1016/j.rmed.2012.10.025 |
| Uncontrolled Keywords: | Asthma; Combination therapy; Fluticasone propionate; flutiform®; Formoterol fumarate; ICS/LABA |
| Subjects: | Pulmonology Therapy. Therapeutic interventions |
| Divisions: | Departments > Department of Internal Medicine 1 (formerly - Faculty Therapy and Endocrinology) |
| Depositing User: | Елена Шрамко |
| Date Deposited: | 13 Mar 2019 12:05 |
| Last Modified: | 13 Mar 2019 12:06 |
| URI: | http://repo.dma.dp.ua/id/eprint/3911 |
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