PT  - JOURNAL ARTICLE
AU  - Piotr Kuna
AU  - Ursula Thyroff-Friesinger
AU  - Ingolf Gath
TI  - Fluticasone/salmeterol combined in the new Forspiro® inhaler is as effective and safe as Seretide® Accuhaler® in adult and pediatric asthmatics
DP  - 2011 Sep 01
TA  - European Respiratory Journal
PG  - p828
VI  - 38
IP  - Suppl 55
4099  - http://erj.ersjournals.com/content/38/Suppl_55/p828.short
4100  - http://erj.ersjournals.com/content/38/Suppl_55/p828.full
SO  - Eur Respir J2011 Sep 01; 38
AB  - Objective: To compare the clinical efficacy and safety of fluticasone/salmeterol (Flu/Salm) combined in the new “Forspiro” DPI with Seretide Accuhaler (Glaxo Wellcome).Methods: We conducted two large clinical phase III studies with twice daily treatment over 12 weeks including more than 770 children and adolescents/adults suffering from moderate or moderate-to-severe asthma. Primary endpoints were FEV1 change from baseline and the area under the FEV1 curve at study termination. Asthma symptom score, reliever use, morning PEF, adverse events (AEs) were also assessed.Results: Mean increase of FEV1 for the 100/50 mcg (low dose) was 276 mL in adolescents/adults and 476 mL in children aged 6-11 years, and 344 ml for 500/50 mcg (high dose) in adults at endpoint. Morning PEF increased with the low dose by 17.5 L/min in adolescents/adults and 31.5 L/min in children, and by 35 L/min with the high dose in adults. Asthma symptom scores and reliever use had already decreased substantially after the first treatment week. The number of drug-related AEs was comparable between treatments. Serum cortisol measured during 12 hours at endpoint tended to lower levels with the reference product. Patients' assessment at study termination revealed an overall preference for the “Forspiro” DPI due to its mouthpiece fit, device size and shape.Conclusions: Flu/Salm in the “Forspiro” inhaler was shown to be as efficacious and safe as Seretide Accuhaler.