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Viapaed Study In Children And Adolescents With Asthma
This study has been completed.
First Received: April 17, 2006   Last Updated: May 15, 2009   History of Changes
Sponsor: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00315744
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: SERETIDE
Drug: Salmeterol
Drug: Fluticasone propionate
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • PEF mean morning

Secondary Outcome Measures:
  • 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).

Estimated Enrollment: 380
Study Start Date: November 2004
  Eligibility

Ages Eligible for Study:   4 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00315744

  Hide Study Locations
Locations
Germany
GSK Investigational Site
Berlin, Germany, 13347
GSK Investigational Site
Berlin, Germany, 13055
GSK Investigational Site
Berlin, Germany, 10965
GSK Investigational Site
Hamburg, Germany, 22045
GSK Investigational Site
Berlin, Germany, 10365
GSK Investigational Site
Berlin, Germany, 10785
Germany, Baden-Wuerttemberg
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70469
GSK Investigational Site
Tuttlingen, Baden-Wuerttemberg, Germany, 78532
GSK Investigational Site
Ettenheim, Baden-Wuerttemberg, Germany, 77955
GSK Investigational Site
Boennigheim, Baden-Wuerttemberg, Germany, 74357
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68167
GSK Investigational Site
Schwaebisch-Hall, Baden-Wuerttemberg, Germany, 74523
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70499
GSK Investigational Site
Schwetzingen, Baden-Wuerttemberg, Germany, 68723
GSK Investigational Site
Sinsheim, Baden-Wuerttemberg, Germany, 74889
GSK Investigational Site
Pfullendorf, Baden-Wuerttemberg, Germany, 88630
GSK Investigational Site
Welzheim, Baden-Wuerttemberg, Germany, 73642
GSK Investigational Site
Bad Krozingen, Baden-Wuerttemberg, Germany, 79189
GSK Investigational Site
Kehl, Baden-Wuerttemberg, Germany, 77694
Germany, Bayern
GSK Investigational Site
Nuernberg, Bayern, Germany, 90473
GSK Investigational Site
Muenchen, Bayern, Germany, 80939
GSK Investigational Site
Lauf, Bayern, Germany, 91207
GSK Investigational Site
Freising, Bayern, Germany, 85354
Germany, Brandenburg
GSK Investigational Site
Schwedt, Brandenburg, Germany, 16303
Germany, Hessen
GSK Investigational Site
Wiesbaden, Hessen, Germany, 65205
GSK Investigational Site
Frankfurt, Hessen, Germany, 60316
Germany, Niedersachsen
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
GSK Investigational Site
Osnabrueck, Niedersachsen, Germany, 49082
GSK Investigational Site
Belm, Niedersachsen, Germany, 49191
GSK Investigational Site
Lueneburg, Niedersachsen, Germany, 21339
Germany, Nordrhein-Westfalen
GSK Investigational Site
Guetersloh, Nordrhein-Westfalen, Germany, 33332
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44791
GSK Investigational Site
Kleve-Materborn, Nordrhein-Westfalen, Germany, 47533
GSK Investigational Site
Wesel, Nordrhein-Westfalen, Germany, 46483
GSK Investigational Site
Bielefeld, Nordrhein-Westfalen, Germany, 33617
GSK Investigational Site
Krefeld, Nordrhein-Westfalen, Germany, 47389
GSK Investigational Site
Aachen, Nordrhein-Westfalen, Germany, 52072
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44795
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44866
GSK Investigational Site
Oberhausen, Nordrhein-Westfalen, Germany, 46145
GSK Investigational Site
Duesseldorf, Nordrhein-Westfalen, Germany, 40599
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44789
GSK Investigational Site
Neuss, Nordrhein-Westfalen, Germany, 41469
GSK Investigational Site
Detmold, Nordrhein-Westfalen, Germany, 32756
GSK Investigational Site
Kempen, Nordrhein-Westfalen, Germany, 47906
Germany, Rheinland-Pfalz
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
GSK Investigational Site
Koblenz, Rheinland-Pfalz, Germany, 56068
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55127
Germany, Sachsen
GSK Investigational Site
Cossebaude, Sachsen, Germany, 01462
GSK Investigational Site
Doebeln, Sachsen, Germany, 04720
GSK Investigational Site
Dresden, Sachsen, Germany, 01169
GSK Investigational Site
Dresden, Sachsen, Germany, 01067
GSK Investigational Site
Leipzig, Sachsen, Germany, 04279
GSK Investigational Site
Wurzen, Sachsen, Germany, 04808
Germany, Schleswig-Holstein
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24944
GSK Investigational Site
Geesthacht, Schleswig-Holstein, Germany, 21502
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: 102318
Study First Received: April 17, 2006
Last Updated: May 15, 2009
ClinicalTrials.gov Identifier: NCT00315744     History of Changes
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:
Asthma
moderate asthma
salmeterol
fluticasone
steroid-sparing
children

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Bronchial Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic Agonists
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Therapeutic Uses
Fluticasone
Dermatologic Agents
Salmeterol
Adrenergic beta-Agonists
Immune System Diseases
Asthma
Anti-Asthmatic Agents
Anti-Allergic Agents
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on November 27, 2009