Efficacy and safety of fluticasone/formoterol combination therapy in patients with moderate-to-severe asthma
| Autor: | Kirsten Kaiser, Tetyana Pertseva, Viktor Blahzko, Lyndon E. Mansfield, Jonathan Corren |
|---|---|
| Rok vydání: | 2013 |
| Předmět: |
Adult
Male Pulmonary and Respiratory Medicine medicine.medical_specialty Adolescent medicine.drug_class Placebo Fluticasone propionate Drug Administration Schedule Young Adult Double-Blind Method Internal medicine Forced Expiratory Volume Administration Inhalation medicine flutiform® ICS/LABA Humans Metered Dose Inhalers Treatment Failure Combination therapy Adrenergic beta-2 Receptor Agonists Fluticasone Asthma Aged Formoterol fumarate Aged 80 and over business.industry Inhaler Middle Aged respiratory system medicine.disease Bronchodilator Agents respiratory tract diseases Androstadienes Drug Combinations Treatment Outcome Ethanolamines Corticosteroid Formoterol Fumarate Female Formoterol business medicine.drug |
| Zdroj: | Respiratory Medicine. 107(2):180-195 |
| ISSN: | 0954-6111 |
| DOI: | 10.1016/j.rmed.2012.10.025 |
| Popis: | Summary Background The inhaled corticosteroid, fluticasone propionate, and the long-acting β 2 -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 μg) administered twice daily (b.i.d.) via a single aerosol inhaler, with the individual components (fluticasone 250 μg b.i.d.; formoterol 10 μg 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 (FEV 1 ) from morning pre-dose at baseline to pre-dose at week 12 (fluticasone/formoterol 250/10 μg vs. formoterol), ii) the mean change in FEV 1 from morning pre-dose at baseline to 2 h post-dose at week 12 (fluticasone/formoterol 250/10 μg vs. fluticasone), and iii) the number of patients who discontinued prematurely due to lack of treatment efficacy (fluticasone/formoterol 250/10 μg 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 μg 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. |
| Databáze: | OpenAIRE |
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