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Viapaed Study In Children And Adolescents With Asthma

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

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

Summary

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.

Clinical Details

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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).

Eligibility

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.

Locations and Contacts

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

Additional Information

Starting date: November 2004
Last updated: March 17, 2011

Page last updated: August 23, 2015

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