Asthmatic children who remain symptomatic on inhaled corticosteroids (ICS) require an
adjustment of their asthma therapy. Current guidelines suggest that the treatment options
are either an increased dose of inhaled corticosteroid or the addition of other therapy such
as a long-acting beta-agonist (LABA). In the paediatric age range, major concerns with
respect to high dose ICS therapy are growth retardation and the suppression of the
hypothalamic-pituitary-adrenocortical (HPA) axis. Previous studies in adults have shown that
a combination product that included a LABA as well as the ICS allowed to reduce the steroid
dose and was still at least as effective in achieving asthma control as treatment with a
higher dose of ICS. These treatment options shall be compared in the present study. Children
who remain symptomatic while inhaling 100 µg fluticasone (FP) twice daily shall be
randomised to receive the salmeterol/ fluticasone combination product, Viani (SERETIDE)
50/100 µg, or fluticasone 200 µg as a comparator drug, inhaled twice daily via the DISKUS
for a period of eight weeks.
Minimum age: 4 Years.
Maximum age: 16 Years.
Gender(s): Both.
GSK Investigational Site, Berlin 10365, Germany
GSK Investigational Site, Berlin 10785, Germany
GSK Investigational Site, Berlin 10965, Germany
GSK Investigational Site, Berlin 13055, Germany
GSK Investigational Site, Berlin 13347, Germany
GSK Investigational Site, Hamburg 22045, Germany
GSK Investigational Site, Bad Krozingen, Baden-Wuerttemberg 79189, Germany
GSK Investigational Site, Boennigheim, Baden-Wuerttemberg 74357, Germany
GSK Investigational Site, Ettenheim, Baden-Wuerttemberg 77955, Germany
GSK Investigational Site, Kehl, Baden-Wuerttemberg 77694, Germany
GSK Investigational Site, Mannheim, Baden-Wuerttemberg 68167, Germany
GSK Investigational Site, Pfullendorf, Baden-Wuerttemberg 88630, Germany
GSK Investigational Site, Schwaebisch-Hall, Baden-Wuerttemberg 74523, Germany
GSK Investigational Site, Schwetzingen, Baden-Wuerttemberg 68723, Germany
GSK Investigational Site, Sinsheim, Baden-Wuerttemberg 74889, Germany
GSK Investigational Site, Stuttgart, Baden-Wuerttemberg 70469, Germany
GSK Investigational Site, Stuttgart, Baden-Wuerttemberg 70499, Germany
GSK Investigational Site, Tuttlingen, Baden-Wuerttemberg 78532, Germany
GSK Investigational Site, Welzheim, Baden-Wuerttemberg 73642, Germany
GSK Investigational Site, Freising, Bayern 85354, Germany
GSK Investigational Site, Lauf, Bayern 91207, Germany
GSK Investigational Site, Muenchen, Bayern 80939, Germany
GSK Investigational Site, Nuernberg, Bayern 90473, Germany
GSK Investigational Site, Schwedt, Brandenburg 16303, Germany
GSK Investigational Site, Frankfurt, Hessen 60316, Germany
GSK Investigational Site, Wiesbaden, Hessen 65205, Germany
GSK Investigational Site, Belm, Niedersachsen 49191, Germany
GSK Investigational Site, Hannover, Niedersachsen 30625, Germany
GSK Investigational Site, Lueneburg, Niedersachsen 21339, Germany
GSK Investigational Site, Osnabrueck, Niedersachsen 49082, Germany
GSK Investigational Site, Aachen, Nordrhein-Westfalen 52072, Germany
GSK Investigational Site, Bielefeld, Nordrhein-Westfalen 33617, Germany
GSK Investigational Site, Bochum, Nordrhein-Westfalen 44791, Germany
GSK Investigational Site, Bochum, Nordrhein-Westfalen 44795, Germany
GSK Investigational Site, Bochum, Nordrhein-Westfalen 44866, Germany
GSK Investigational Site, Bochum, Nordrhein-Westfalen 44789, Germany
GSK Investigational Site, Detmold, Nordrhein-Westfalen 32756, Germany
GSK Investigational Site, Duesseldorf, Nordrhein-Westfalen 40599, Germany
GSK Investigational Site, Guetersloh, Nordrhein-Westfalen 33332, Germany
GSK Investigational Site, Kempen, Nordrhein-Westfalen 47906, Germany
GSK Investigational Site, Kleve-Materborn, Nordrhein-Westfalen 47533, Germany
GSK Investigational Site, Krefeld, Nordrhein-Westfalen 47389, Germany
GSK Investigational Site, Neuss, Nordrhein-Westfalen 41469, Germany
GSK Investigational Site, Oberhausen, Nordrhein-Westfalen 46145, Germany
GSK Investigational Site, Wesel, Nordrhein-Westfalen 46483, Germany
GSK Investigational Site, Koblenz, Rheinland-Pfalz 56068, Germany
GSK Investigational Site, Mainz, Rheinland-Pfalz 55127, Germany
GSK Investigational Site, Mainz, Rheinland-Pfalz 55131, Germany
GSK Investigational Site, Cossebaude, Sachsen 01462, Germany
GSK Investigational Site, Doebeln, Sachsen 04720, Germany
GSK Investigational Site, Dresden, Sachsen 01169, Germany
GSK Investigational Site, Dresden, Sachsen 01067, Germany
GSK Investigational Site, Leipzig, Sachsen 04279, Germany
GSK Investigational Site, Wurzen, Sachsen 04808, Germany
GSK Investigational Site, Flensburg, Schleswig-Holstein 24944, Germany
GSK Investigational Site, Geesthacht, Schleswig-Holstein 21502, Germany