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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00197106 |
Purpose
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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | See Detailed Description |
| Enrollment: | 176 |
| Study Start Date: | June 2005 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: arm 1 |
Drug: Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg
comparator
Drug: fluticasone propionate 2 x 100 mcg
comparator
Other Names:
|
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.
Eligibility| 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:
Contacts and Locations| Netherlands | |
| GSK Investigational Site | |
| Almere, Netherlands, 1315 RA | |
| GSK Investigational Site | |
| Amsterdam, Netherlands, 1105 AZ | |
| GSK Investigational Site | |
| Arnhem, Netherlands, 6815 AD | |
| GSK Investigational Site | |
| Breda, Netherlands, 4819 EV | |
| GSK Investigational Site | |
| Den Haag, Netherlands, 2566 MJ | |
| GSK Investigational Site | |
| Eindhoven, Netherlands, 5623 EJ | |
| GSK Investigational Site | |
| Enschede, Netherlands, 7511JX | |
| GSK Investigational Site | |
| Gouda, Netherlands, 2803 HG | |
| GSK Investigational Site | |
| Groningen, Netherlands, 9713 GZ | |
| GSK Investigational Site | |
| Helmond, Netherlands, 5707 HA | |
| GSK Investigational Site | |
| Hoorn, Netherlands, 1624 NP | |
| GSK Investigational Site | |
| Leeuwarden, Netherlands, 8934 AD | |
| GSK Investigational Site | |
| Maastricht, Netherlands, 6229 HX | |
| GSK Investigational Site | |
| Nijmegen, Netherlands, 6532 SZ | |
| GSK Investigational Site | |
| Sittard, Netherlands, 6131 BK | |
| GSK Investigational Site | |
| Utrecht, Netherlands, 3584 CX | |
| GSK Investigational Site | |
| Veldhoven, Netherlands, 5504 DB | |
| GSK Investigational Site | |
| Zwolle, Netherlands, 8025 AB | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00197106 History of Changes |
| Other Study ID Numbers: | SAM101667 |
| Study First Received: | September 9, 2005 |
| Results First Received: | September 11, 2009 |
| Last Updated: | March 21, 2011 |
| Health Authority: | Netherlands: Medicines Evaluation Board (MEB) |
|
salmeterol/fluticasone combination Asthma bronchial hyperresponsiveness Children symptom control |
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Salmeterol Fluticasone Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents |