Eformoterol Turbohaler compared with salmeterol by dry powder inhaler in asthmatic children not controlled on inhaled corticosteroids.
The aim of the study was to compare the efficacy of the inhaled long-acting beta2-agonists eformoterol and salmeterol when added to existing inhaled corticosteroid (ICS) therapy in symptomatic asthmatic children. This randomized, 12-week, parallel-group study, performed in a primary care setting, included 156 children and adolescents (aged 6-17 years) with moderate persistent asthma. Patients were randomized to open-label eformoterol (Oxis) Turbohaler 9 microg (delivered dose) or salmeterol Accuhaler 50 microg, both b.i.d, added to current ICS. Assessments included: changes in daytime reliever beta2-agonist therapy (primary variable), total 24-h reliever use, lung function, clinic and diary symptom scores, patient and carer health-related quality of life (HRQL) and adverse events. Daytime reliever use decreased significantly (p < 0.001) from baseline by 65% and 52%, respectively in the eformoterol and salmeterol treatment groups. Compared with salmeterol, eformoterol produced a greater decrease in daytime (-0.46 inhalations/day; p = 0.081) and 24-h (-0.70 inhalations/day; p = 0.043) reliever use. The percentage of patients who did not require any reliever medication during the study was significantly higher in the eformoterol group (p < 0.05 vs. salmeterol at weeks 8 and 12). Clinic and diary card peak expiratory flow and symptom measures all improved from baseline in both treatment arms. There was a significantly greater effect in favour of eformoterol for the reduction in clinic-assessed overall night-time symptoms (p < 0.05 vs. salmeterol). Clinically relevant improvements in patient-assessed HRQL occurred during treatment with eformoterol and salmeterol, but carer-assessed HRQL was improved to a clinically relevant extent, only with eformoterol. Both treatments were well tolerated. In children and adolescents with moderate persistent asthma, add-on therapy with eformoterol was well tolerated and at least as effective as salmeterol.
Birchwood Medical Surgery, Park Lane, North Walsham, Norfolk NR28 0BQ, UK. paul.everden@nhs.net
Paul
P
Everden
Malcolm
M
Campbell
Chris
C
Harnden
Hugh
H
McGoldrick
Bavesh
B
Bodalia
Victoria
V
Manion
Sarah
S
Reynia
D000280:Administration, Inhalation; D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage; D000318:Adrenergic beta-Agonists / Q000008:administration & dosage*; D000420:Albuterol / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage; D001249:Asthma / Q000188:drug therapy*; D017028:Caregivers; D002648:Child; D004983:Ethanolamines / Q000008:administration & dosage*; D005260:Female; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D011208:Powders / Q000008:administration & dosage; D012123:Pulmonary Ventilation; D011788:Quality of Life; D000068299:Salmeterol Xinafoate; D016896:Treatment Outcome
D000305:Adrenal Cortex Hormones; D000318:Adrenergic beta-Agonists; D000893:Anti-Inflammatory Agents; D004983:Ethanolamines; D011208:Powders; D000068299:Salmeterol Xinafoate; D000420:Albuterol; D000068759:Formoterol Fumarate