Viapaed Study In Children And Adolescents With Asthma

Condition(s) targeted: Asthma

Intervention: SERETIDE (Drug); Salmeterol (Drug); Fluticasone propionate (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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.

Official title: Steroid-Sparing Management of the Salmeterol/Fluticasone 50/100µg b.i.d. Combination Compared to Fluticasone 200µg b.i.d. in Children and Adolescents With Moderate Asthma

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: PEF mean morning

Secondary outcome: Asthma symptom score (day/night 0-4). Number of calendar days (24 h) without symptoms. Use of rescue medication (salbutamol). Number of well controlled asthma weeks. Change in mean morning PEF (% predicted).

Minimum age: 4 Years. Maximum age: 16 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Children aged 4 to 16 years with an established history of perennial asthma.

- Subjects who are treated with an inhaled corticosteroid according to BDP (budesonide)

200-400 µg/day or equivalent during the last 4 weeks before run-in.

- 15 minutes after inhaling 200µg of salbutamol, reversible increase in FEV1 of at least

12% of the pre-dose value.

- Willingness to substitute previous controller medication on the twice daily inhalation

of fluticasone 100µg bid via DISKUS®.

- Subjects/guardians who have given written informed consent to participate in the

study.

- Subjects /guardians who are able to understand and complete a diary record card

(DRC).

- Subjects who are able to use a Mini-Wright Peak Flow meter.

- Sexually active female adolescents must use adequate contraception.

- Willingness to refrain from any other controller medication (including

anti-leukotrienes) or from regular use of short-acting beta agonists or anticholinergics during the treatment period.

GSK Clinical Trials Call Center, Forchheim 91301, Germany

GSK Clinical Trials Call Center, Bochum 44795, Germany

GSK Clinical Trials Call Center, Hamburg 22045, Germany

GSK Clinical Trials Call Center, Lauf a.d. Pegnitz 91207, Germany

GSK Clinical Trials Call Center, Wetzlar 35576, Germany

GSK Clinical Trials Call Center, Frankfurt a. Main 60316, Germany

GSK Clinical Trials Call Center, Detmold 32756, Germany

GSK Clinical Trials Call Center, Luneburg 21339, Germany

GSK Clinical Trials Call Center, Belm 49191, Germany

GSK Clinical Trials Call Center, Oberhausen 46145, Germany

GSK Clinical Trials Call Center, Euskirchen 53879, Germany

GSK Clinical Trials Call Center, Krefeld 47839, Germany

GSK Clinical Trials Call Center, Niedernhausen 65527, Germany

GSK Clinical Trials Call Center, Willich 47877, Germany

GSK Clinical Trials Call Center, Braunfels 35619, Germany

GSK Clinical Trials Call Center, Blaustein 89134, Germany

GSK Clinical Trials Call Center, Heidelberg 69115, Germany

GSK Clinical Trials Call Center, Kempen 47906, Germany

GSK Clinical Trials Call Center, Gaibach 83674, Germany

GSK Clinical Trials Call Center, Kehl 77694, Germany

GSK Clinical Trials Call Center, Bielefeld 33604, Germany

GSK Clinical Trials Call Center, Trier 54294, Germany

GSK Clinical Trials Call Center, Nurnberg 90473, Germany

GSK Clinical Trials Call Center, Gutersloh 33332, Germany

GSK Clinical Trials Call Center, Munchen 80939, Germany

GSK Clinical Trials Call Center, Hannover 30625, Germany

GSK Clinical Trials Call Center, Schwetzingen 68723, Germany

GSK Clinical Trials Call Center, Berlin 10365, Germany

GSK Clinical Trials Call Center, Essen 45122, Germany

GSK Clinical Trials Call Center, Dortmund 44137, Germany

GSK Clinical Trials Call Center, Mainz 55131, Germany

GSK Clinical Trials Call Center, Ettenheim 77955, Germany

GSK Clinical Trials Call Center, Osnabruck 49082, Germany

GSK Clinical Trials Call Center, Bonnigheim 74357, Germany

GSK Clinical Trials Call Center, Dresden 01169, Germany

GSK Clinical Trials Call Center, Mannheim 68167, Germany

GSK Clinical Trials Call Center, Stuttgart 70469, Germany

GSK Clinical Trials Call Center, Koln 50931, Germany

GSK Clinical Trials Call Center, Wiesbaden 65205, Germany

GSK Clinical Trials Call Center, Flensburg 24944, Germany

GSK Clinical Trials Call Center, Bochum 44791, Germany

GSK Clinical Trials Call Center, Dusseldorf 40225, Germany

GSK Clinical Trials Call Center, Kleve Materborn 47533, Germany

GSK Clinical Trials Call Center, Dresden-Cossebaude 01462, Germany

GSK Clinical Trials Call Center, Munchen 81242, Germany

GSK Clinical Trials Call Center, Schwabisch Hall 74523, Germany

GSK Clinical Trials Call Center, Wesel 46483, Germany

GSK Clinical Trials Call Center, Berlin 13055, Germany

GSK Clinical Trials Call Center, Bielefeld 33617, Germany

GSK Clinical Trials Call Center, Geesthacht 21502, Germany

GSK Clinical Trials Call Center, Bochum 44789, Germany

GSK Clinical Trials Call Center, Dobeln 04720, Germany

GSK Clinical Trials Call Center, Berlin 10965, Germany

GSK Clinical Trials Call Center, Stuttgart 70499, Germany

GSK Clinical Trials Call Center, Bochum 44866, Germany

GSK Clinical Trials Call Center, Koblenz 56068, Germany

GSK Clinical Trials Call Center, Minden 32427, Germany

GSK Clinical Trials Call Center, Berlin 14163, Germany

GSK Clinical Trials Call Center, Leipzig 04279, Germany

GSK Clinical Trials Call Center, Dresden 01067, Germany

GSK Clinical Trials Call Center, Aachen 52072, Germany

GSK Clinical Trials Call Center, Hamburg 22415, Germany

GSK Clinical Trials Call Center, Welzheim 73642, Germany

GSK Clinical Trials Call Center, Berlin 10997, Germany

GSK Clinical Trials Call Center, Halle 33790, Germany

GSK Clinical Trials Call Center, Remscheid 42899, Germany

GSK Clinical Trials Call Center, Neuss 41469, Germany

GSK Clinical Trials Call Center, Berlin 10787, Germany

GSK Clinical Trials Call Center, Mainz 55127, Germany

GSK Clinical Trials Call Center, Sinsheim 74889, Germany

GSK Clinical Trials Call Center, Pfullendorf 88630, Germany

GSK Clinical Trials Call Center, Bottrop 46242, Germany

GSK Clinical Trials Call Center, Frankfurt 15236, Germany

GSK Clinical Trials Call Center, Berlin 12161, Germany

GSK Clinical Trials Call Center, Kassel 34121, Germany

GSK Clinical Trials Call Center, Wurzen 04808, Germany

GSK Clinical Trials Call Center, Nurnberg 90449, Germany

GSK Clinical Trials Call Center, Neuss 41462, Germany

GSK Clinical Trials Call Center, Dusseldorf 40599, Germany

GSK Clinical Trials Call Center, Bad Krozingen 79189, Germany

GSK Clinical Trials Call Center, Freising 85354, Germany

GSK Clinical Trials Call Center, Tuttlingen 78532, Germany

GSK Clinical Trials Call Center, Villingen-Schwenningen 78056, Germany

Starting date: September 2004
Last updated: November 7, 2007