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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00448435 |
To evaluate the efficacy and safety of GW815SF HFA MDI 25/50µg 1 inhalation bid in comparison with concomitant treatment with salmeterol xinafoate DPI 25µg 1 inhalation bid plus fluticasone propionate DPI 50µg 1 inhalation bid in paediatric patients with asthma. To evaluate the safety of long-term treatment of GW815SF HFA MDI 25/50µg 1 inhalation bid in paediatric patients with asthma.
Condition | Intervention | Phase |
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Bronchial Asthma |
Drug: GW815SF HFA MDI Drug: salmeterol and fluticasone propionate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Efficacy Study |
Official Title: | A Study to Compare GW815SF HFA MDI With Concomitant Treatment With Salmeterol Xinafoate DPI Plus Fluticasone Propionate DPI and to Assess Long-Term Safety of GW815SF HFA MDI |
Enrollment: | 51 |
Study Start Date: | April 2007 |
Study Completion Date: | January 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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SLM+FP First: Active Comparator
SLM(salmeterol) 25mcg + FP(fluticasone propionate) 50mcg twice daily in first intervention period and SFC(salmeterol/fluticasone propionate) 25/50mcg twice daily in second intervention period and (after washout period).
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Drug: GW815SF HFA MDI
salmeterol and fluticasone propionate combination
Drug: salmeterol and fluticasone propionate
salmeterol + fluticasone propionate
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SFC First: Active Comparator
SFC (Salmeterol/Fluticasone propionate combination) 25/50mcg twice daily in first intervention period and SLM (Salmeterol) 25mcg + FP (Fluticasone Propionate) 50mcg twice daily in second intervention period (after washout period).
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Drug: GW815SF HFA MDI
salmeterol and fluticasone propionate combination
Drug: salmeterol and fluticasone propionate
salmeterol + fluticasone propionate
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SFC: Experimental
SFC (salmeterol/fluticasone propionate combination) 25/50mcg twice daily in Extension period (after cross-over period).
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Drug: GW815SF HFA MDI
salmeterol and fluticasone propionate combination
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Ages Eligible for Study: | 5 Years to 14 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Inclusion Criteria for Entry in Treatment Period 1 A subject will be randomized to one of the two treatment groups only if he/she has completed the run-in period and meets all the following criteria.
Exclusion criteria:
A patient who applies any of the following criteria is not eligible for the study:
Exclusion Criteria for Entry in Treatment Period 1 Enrolment of a subject completing the run-in period into Treatment Period 1 will not be allowed if any of the following applies:
Exclusion Criteria for Entry in Treatment Period 2 Enrolment of a subject completing the washout period into Treatment Period 2 will not be allowed if any of the following applies:
Japan | |
GSK Investigational Site | |
Kanagawa, Japan, 245-0018 | |
GSK Investigational Site | |
Chiba, Japan, 260-0001 | |
GSK Investigational Site | |
Saitama, Japan, 360-0018 | |
GSK Investigational Site | |
Saitama, Japan, 360-0812 | |
GSK Investigational Site | |
Tokyo, Japan, 158-0083 | |
GSK Investigational Site | |
Tokyo, Japan, 154-0017 | |
GSK Investigational Site | |
Tokyo, Japan, 158-0057 | |
GSK Investigational Site | |
Tokyo, Japan, 154-0002 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 110099 |
Study First Received: | March 14, 2007 |
Results First Received: | January 19, 2009 |
Last Updated: | June 25, 2009 |
ClinicalTrials.gov Identifier: | NCT00448435 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Salmeterol Fluticasone propionate Salmeterol/Fluticasone propionate combination Pediatric bronchial asthma |
Anti-Inflammatory Agents Neurotransmitter Agents Salmeterol Bronchial Diseases Adrenergic Agents Adrenergic beta-Agonists Anti-Asthmatic Agents Asthma Anti-Allergic Agents Adrenergic Agonists |
Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Lung Diseases Hypersensitivity, Immediate Fluticasone Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
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 |