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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00448435 |
Purpose
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 |
|---|---|---|
|
Bronchial Asthma |
Drug: GW815SF HFA MDI Drug: salmeterol and fluticasone propionate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
|---|---|
|
Active Comparator: SLM+FP First
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).
|
Drug: GW815SF HFA MDI
salmeterol and fluticasone propionate combination
Other Name: salmeterol/fluticasone propionate combination
Drug: salmeterol and fluticasone propionate
salmeterol + fluticasone propionate
|
|
Active Comparator: SFC First
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).
|
Drug: GW815SF HFA MDI
salmeterol and fluticasone propionate combination
Other Name: salmeterol/fluticasone propionate combination
Drug: salmeterol and fluticasone propionate
salmeterol + fluticasone propionate
|
|
Experimental: SFC
SFC (salmeterol/fluticasone propionate combination) 25/50mcg twice daily in Extension period (after cross-over period).
|
Drug: GW815SF HFA MDI
salmeterol and fluticasone propionate combination
Other Name: salmeterol/fluticasone propionate combination
|
Eligibility| Ages Eligible for Study: | 5 Years to 14 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
A pediatric patient already diagnosed as having bronchial asthma who meets all of the following criteria is eligible for the study:
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:
Contacts and Locations| Japan | |
| GSK Investigational Site | |
| Chiba, Japan, 260-0001 | |
| GSK Investigational Site | |
| Kanagawa, Japan, 245-0018 | |
| GSK Investigational Site | |
| Saitama, Japan, 360-0812 | |
| GSK Investigational Site | |
| Saitama, Japan, 360-0018 | |
| GSK Investigational Site | |
| Tokyo, Japan, 158-0097 | |
| GSK Investigational Site | |
| Tokyo, Japan, 154-0002 | |
| GSK Investigational Site | |
| Tokyo, Japan, 154-0017 | |
| GSK Investigational Site | |
| Tokyo, Japan, 158-0083 | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | Study Director, GSK |
| ClinicalTrials.gov Identifier: | NCT00448435 History of Changes |
| Other Study ID Numbers: | 110099 |
| Study First Received: | March 14, 2007 |
| Results First Received: | January 19, 2009 |
| Last Updated: | June 3, 2010 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
|
Salmeterol Fluticasone propionate Salmeterol/Fluticasone propionate combination Pediatric bronchial asthma |
|
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 |