Randomised trial of once-daily vilanterol in children with asthma on inhaled corticosteroid therapy
| Autor: | Ryan M. Klein, Ronina A. Covar, Jonathan Grigg, Christine A. Sorkness, Caroline Goldfrad, Susan A. Tomkins, Søren Pedersen, César Villarán, Amanda Oliver |
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| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Male
Fluticasone propionate chemistry.chemical_compound 0302 clinical medicine Adrenal Cortex Hormones Clinical endpoint Anti-Asthmatic Agents 030212 general & internal medicine Vilanterol Child Children Fluticasone education.field_of_study Combined Modality Therapy Bronchodilator Agents Treatment Outcome Child Preschool Anesthesia Female Safety medicine.drug Pulmonary and Respiratory Medicine medicine.medical_specialty Evening Efficacy Population Chlorobenzenes Placebo Drug Administration Schedule 03 medical and health sciences Double-Blind Method Internal medicine Administration Inhalation Dose response medicine Humans education Benzyl Alcohols Asthma Dose-Response Relationship Drug business.industry Research Placebo Effect medicine.disease 030228 respiratory system chemistry business |
| Zdroj: | Oliver, A J, Covar, R A, Goldfrad, C H, Klein, R M, Pedersen, S E, Sorkness, C A, Tomkins, S A, Villarán, C & Grigg, J 2016, ' Randomised trial of once-daily vilanterol in children with asthma on inhaled corticosteroid therapy ', Respiratory Research, vol. 17, 37 . https://doi.org/10.1186/s12931-016-0353-4 Respiratory Research |
| Popis: | Inhaled corticosteroids (ICS) are effective maintenance treatments for childhood asthma; however, many children remain uncontrolled. Vilanterol (VI) is an inhaled long-acting beta-2 agonist which, in combination with the ICS fluticasone furoate, is being explored as a once-daily treatment for asthma in children. We evaluated the dose–response, efficacy, and safety of once-daily VI (6.25 μg, 12.5 μg and 25 μg) administered in the evening over 4 weeks, on background fluticasone propionate (FP) in children with asthma inadequately controlled on ICS. This was a Phase IIb, multicentre, randomised, double-blind, parallel-group, placebo-controlled study in children ages 5–11 years with persistent asthma on ICS and as-needed short-acting beta-agonist. The study comprised a 4-week run-in, 4-week treatment period, and 1-week follow-up. From study start, children replaced their current ICS with open-label FP 100 μg twice daily. Children were randomised to receive placebo, VI 6.25 μg, VI 12.5 μg or VI 25 μg once daily. Primary endpoint was treatment difference between VI 25 and placebo groups in mean change from baseline in evening peak expiratory flow averaged over the 4-week treatment. Secondary endpoints included change from baseline in trough forced expiratory volume in one second (FEV1) at Week 4 and change from baseline in percentage of rescue-free and symptom-free 24-h periods. Safety assessments included incidence of adverse events (AEs) and asthma exacerbations. In total, 456 children comprised the intention-to-treat population. The adjusted treatment difference between VI 25 and placebo groups for the primary endpoint was not statistically significant (p = 0.227) so no statistical inference was made for other VI dose comparisons or other endpoints. No difference in change from baseline in trough FEV1 was observed for any VI treatments versus placebo; however, VI 25 resulted in an additional 0.6 rescue-free days and 0.7 symptom-free days per week versus placebo. The incidence of AEs was slightly higher in the VI groups (28–33 %) versus placebo (22 %). Nine children experienced asthma exacerbations during the treatment period. VI plus FP did not result in significant improvements in lung function versus placebo plus FP, but was well tolerated at all doses assessed. NCT01573767 (ClinicalTrials.gov). |
| Databáze: | OpenAIRE |
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