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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00353873 |
Purpose
This study will compare two treatment strategies (doubling the dose of inhaled steroids or adding a long acting beta2 agonist to the inhaled steroid at the same dose) in children not controlled by inhaled steroid alone at medium dose. The fixed combination SERETIDE 100/50 one inhalation twice daily will be compared to FLIXOTIDE 100 two inhalations twice daily.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Fluticasone propionate Drug: Fluticasone propionate/salmeterol |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study |
| Official Title: | See Detailed Description |
| Estimated Enrollment: | 506 |
| Study Start Date: | November 2005 |
A multicentre, randomised, double-blind, double dummy, parallel group study to compare the salmeterol/fluticasone propionate combination (SERETIDE™) at a dose of 50/100mcg twice daily and fluticasone propionate (FLIXOTIDE™) at a dose of 200mcg twice daily, both delivered via a dry powder inhaler (DISKUS™) for 12 weeks in asthma in children aged 4-11 years not controlled by inhaled corticosteroids alone at medium dose
Eligibility| Ages Eligible for Study: | 4 Years to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
At the end of the run-in period (Visit 2), subjects must still meet the criteria for entry into the run-in period and also have:
Exclusion criteria:
Subjects will be excluded from participating in the treatment period of the study if the following occurred during the run-in period:
Contacts and Locations
Show 58 Study Locations| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | SAM104926 |
| Study First Received: | July 18, 2006 |
| Last Updated: | May 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00353873 History of Changes |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
asthmatics children 4-11 years asthma-control SERETIDE FLIXOTIDE |
|
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 |