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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00449046 |
This study evaluates the long-term (24-week) safety and efficacy of GW815SF Salmeterol/fluticasone propionate(HFA MDI) 50/100mcg(administered as 2 inhalations of 25/50mcg) bid in pediatric patients with bronchial asthma.
Condition | Intervention | Phase |
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Bronchial Asthma |
Drug: GW815SF Salmeterol/Fluticasone propionate(HFA MDI) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Clinical Assessment of GW815SF Salmeterol/Fluticasone Propionate (HFA MDI) in Pediatric Patients With Bronchial Asthma -A Long Term (24-Week) Study- |
Enrollment: | 40 |
Study Start Date: | March 2007 |
Study Completion Date: | November 2007 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 5 Years to 14 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Consent of the subject him/herself should also be obtained, wherever possible, after giving an explanation in an as easy to understand as possible manner.
Inclusion Criteria for Entry in Treatment Period A subject will be considered eligible for inclusion in the treatment period only if he/she has completed the run-in period and meets the following criterion.
1. Has been able, in the investigator's/subinvestigator's judgment, to make entries in the asthma diary and measure PEF, as directed, during the run-in period.
Exclusion criteria:
A patient who applies any of the following criteria is not eligible for the study:
Exclusion Criteria for Entry in Treatment Period
A subject who applies to any of the following criteria is not eligible for the study:
Japan | |
GSK Clinical Trials Call Center | |
Funabashi, Chiba, Japan, 273 | |
GSK Clinical Trials Call Center | |
Setagaya, Tokyo, Japan, 157 | |
GSK Clinical Trials Call Center | |
Takasaki, Gunma, Japan, 370 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Study ID Numbers: | 110101 |
Study First Received: | March 16, 2007 |
Results First Received: | November 21, 2008 |
Last Updated: | June 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00449046 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
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 |