Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00197106 |
This study is being conducted to investigate whether in childhood salmeterol/ fluticasone propionate 50/100 bd delivered via the Diskus® inhaler and fluticasone propionate 200 mcg bd delivered via the Diskus® inhaler are non- inferior in terms of symptom control. Additionally we aim to show that salmeterol/ fluticasone propionate 50/100 bd is at least as good in terms of lung function improvement and bronchial hyperreactivity and enables a steroid-sparing management of asthma in children.
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg Drug: fluticasone propionate 2 x 100 mcg |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study |
Official Title: | See Detailed Description |
Estimated Enrollment: | 200 |
Study Start Date: | June 2005 |
Estimated Study Completion Date: | November 2008 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
A multicentre, randomised, double blind, parallel group study to compare the efficacy and safety of Salmeterol/Fluticasone propionate combination product (Seretide®) 50/100mcg with Fluticasone propionate (Flixotide®) 200mcg, both delivered twice daily via the DISKUS inhaler, in the treatment of children aged 6-12 years with symptomatic asthma.
Ages Eligible for Study: | 6 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
of non-child-bearing potential; OR of child-bearing potential, but not lactating and pregnant. She declares that it is not probable that she will become pregnant during the study (a pregnancy test can be performed at the investigators discretion)
Exclusion criteria:
Netherlands | |
GSK Investigational Site | |
AMSTERDAM, Netherlands, 1105 AZ | |
GSK Investigational Site | |
UTRECHT, Netherlands, 3584 CX | |
GSK Investigational Site | |
LEEUWARDEN, Netherlands, 8934 AD | |
GSK Investigational Site | |
Gouda, Netherlands, 2803 HG | |
GSK Investigational Site | |
NIJMEGEN, Netherlands, 6532 SZ | |
GSK Investigational Site | |
HELMOND, Netherlands, 5707 HA | |
GSK Investigational Site | |
ZWOLLE, Netherlands, 8025 AB | |
GSK Investigational Site | |
MAASTRICHT, Netherlands, 6229 HX | |
GSK Investigational Site | |
ARNHEM, Netherlands, 6815 AD | |
GSK Investigational Site | |
VELDHOVEN, Netherlands, 5504 DB | |
GSK Investigational Site | |
GRONINGEN, Netherlands, 9713 GZ | |
GSK Investigational Site | |
HOORN, Netherlands, 1624 NP | |
GSK Investigational Site | |
DEN HAAG, Netherlands, 2566 MJ | |
GSK Investigational Site | |
ENSCHEDE, Netherlands, 7511JX | |
GSK Investigational Site | |
SITTARD, Netherlands, 6131 BK | |
GSK Investigational Site | |
ALMERE, Netherlands, 1315 RA | |
GSK Investigational Site | |
EINDHOVEN, Netherlands, 5623 EJ | |
GSK Investigational Site | |
BREDA, Netherlands, 4819 EV |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | SAM101667, COMBO |
Study First Received: | September 9, 2005 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00197106 |
Health Authority: | Netherlands: Medicines Evaluation Board (MEB) |
Children Asthma bronchial hyperresponsiveness symptom control salmeterol/fluticasone combination |
Hypersensitivity Lung Diseases, Obstructive Salmeterol Respiratory Tract Diseases Lung Diseases |
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 |