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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00158834 |
This study was designed to evaluate if, in children with asthma, a stepwise treatment (five levels varying from once daily fluticasone propionate 100mcg until twice daily a fixed combination of salmeterol and fluticasone propionate 50/500 mcg) based on symptom scores alone results in a sub-optimal treatment when compared to treatment based on cumulative symptom scores and bronchial hyperresponsiveness (PD20 methacholine).
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: Salmeterol/Fluticasone propionate combination product Drug: Fluticasone propionate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study |
Official Title: | Comparison of Stepwise Treatment of Asthmatic Children With Salmeterol/Fluticasone Propionate Combination Product (Seretide®) and/or Fluticasone Propionate (Flixotide®) Based on PD20 Methacholine and Symptoms or Based on Symptoms Only (Children Asthma Therapy Optimal) |
Ages Eligible for Study: | 6 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Netherlands | |
GSK Investigational Site | |
UTRECHT, Netherlands, 3584 EA | |
GSK Investigational Site | |
HILVERSUM, Netherlands, 1213 VX | |
GSK Investigational Site | |
EINDHOVEN, Netherlands, 5623 EJ | |
GSK Investigational Site | |
AMSTERDAM, Netherlands, 1105 AZ | |
GSK Investigational Site | |
AMSTERDAM, Netherlands, 1081 HV | |
GSK Investigational Site | |
MAASTRICHT, Netherlands, 6229 HX | |
GSK Investigational Site | |
SITTARD, Netherlands, 6131 BK | |
GSK Investigational Site | |
LEIDEN, Netherlands, 2333 ZA | |
GSK Investigational Site | |
ALMERE, Netherlands, 1315 RA | |
GSK Investigational Site | |
ZWOLLE, Netherlands, 8011 JW | |
GSK Investigational Site | |
HILVERSUM, Netherlands, 1213 VX | |
GSK Investigational Site | |
VELDHOVEN, Netherlands, 5504 DB | |
GSK Investigational Site | |
DEN HAAG, Netherlands, 2566 MJ | |
GSK Investigational Site | |
ROTTERDAM, Netherlands, 3015 GD | |
GSK Investigational Site | |
ALKMAAR, Netherlands, 1815 JD | |
GSK Investigational Site | |
GRONINGEN, Netherlands, 9713 GZ | |
GSK Investigational Site | |
BREDA, Netherlands, 4818 CK | |
GSK Investigational Site | |
AMSTERDAM, Netherlands, 1081 HV |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | SAS30018, SER9702/CATO |
Study First Received: | September 8, 2005 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00158834 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Children Asthma bronchial hyperresponsiveness symptoms |
Hypersensitivity Lung Diseases, Obstructive Salmeterol Respiratory Tract Diseases Lung Diseases Methacholine Chloride |
Hypersensitivity, Immediate Fluticasone Asthma Bronchial Hyperreactivity Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Bronchial Diseases Immune System Diseases Adrenergic beta-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
Anti-Asthmatic Agents Anti-Allergic Agents Adrenergic Agonists Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Dermatologic Agents Bronchodilator Agents |