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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW815SF Salmeterol/Fluticasone propionate(HFA MDI) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Most Frequent Adverse Events - On Therapy | Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead electrocardiogram (ECG), Oropharyngeal examination were included. | Baseline to Week 24 |
| Serious Adverse Events (SAEs) - On Therapy | Number of participants considered by the investigator to be related to study medication. Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead ECG, Oropharyngeal examination were included. Frequency threshold of reported SAE's is 0%(100% reported) | Baseline to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Morning Peak Expiratory Flow (PEF) During Weeks 1-24 | PEF taken daily and average used for week 1-24 value. The peak expiratory flow rate measures how fast a person can (exhale) air. Then, compares it to normal flow rates to predict obstruction and disease. The average PEF for a child or adolescent whose height is 43" is 147 L/min, whose height is 66" is 454 L/min. | Baseline and during Weeks 1-24 |
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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 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:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials, MD | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Clinical Trials Call Center | Funabashi, Chiba | 273 | Japan | |||
| GSK Clinical Trials Call Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Salmeterol/Fluticasone Propionate | Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Change From Baseline in Percent Predicted Morning Peak Expiratory Flow (PEF) During Weeks 1-24 | Percent Predicted Morning Peak Expiratory flow were the percent of patients that were predicted to have their Peak expiratory flow in the morning. | Baseline and during Weeks 1-24 |
| Change From Baseline in Evening Peak Expiratory Flow (PEF) During Weeks 1-24 | The peak expiratory flow rate measures how fast a person can (exhale) air. Then compares it to normal flow rates to predict obstruction and disease. The average PEF for a child or adolescent whose height is 43" is 147 L/min, whose height is 66" is 454 L/min. | Baseline and during Weeks 1-24 |
| Change From Baseline in Circadian Variation in Peak Expiratory Flow (PEF) During Weeks 1-24 | Circadian Variation means the various changes in a day. The peak expiratory flow rate measures how fast a person can (exhale) air using a mini-Wright peak flow meter. The average PEF for a child or adolescent whose height is 43" is 147 L/min, whose height is 66" is 454 L/min. | Baseline and during Weeks 1-24 |
| Number of Participants With Symptom-Free Nights and Days | Baseline and Week 24 |
| Number of Participants With Rescue Medication-Free Nights and Days | Rescue free means without the use of other medication. | Baseline and Week 24 |
| Setagaya, Tokyo |
| 157 |
| Japan |
| GSK Clinical Trials Call Center | Takasaki, Gunma | 370 | Japan |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Salmeterol/Fluticasone Propionate | Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | One participant counted twice due to having multiple races. | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Most Frequent Adverse Events - On Therapy | Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead electrocardiogram (ECG), Oropharyngeal examination were included. | Safety analysis was performed on the primary outcome measures, adverse events and on the safety population defined as all subjects who entered the treatment period and received at least one dose of study medication | Posted | Number | Participants | Baseline to Week 24 |
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| Primary | Serious Adverse Events (SAEs) - On Therapy | Number of participants considered by the investigator to be related to study medication. Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead ECG, Oropharyngeal examination were included. Frequency threshold of reported SAE's is 0%(100% reported) | Safety analysis was performed on the primary outcome measures, adverse events and on the safety population defined as all subjects who entered the treatment period and received at least one dose of study medication. | Posted | Number | Participants | Baseline to Week 24 |
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| Secondary | Change From Baseline in Morning Peak Expiratory Flow (PEF) During Weeks 1-24 | PEF taken daily and average used for week 1-24 value. The peak expiratory flow rate measures how fast a person can (exhale) air. Then, compares it to normal flow rates to predict obstruction and disease. The average PEF for a child or adolescent whose height is 43" is 147 L/min, whose height is 66" is 454 L/min. | Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data. | Posted | Mean | Standard Deviation | L/min | Baseline and during Weeks 1-24 |
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| Secondary | Change From Baseline in Percent Predicted Morning Peak Expiratory Flow (PEF) During Weeks 1-24 | Percent Predicted Morning Peak Expiratory flow were the percent of patients that were predicted to have their Peak expiratory flow in the morning. | Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data. | Posted | Mean | Standard Deviation | Percent Change | Baseline and during Weeks 1-24 |
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| Secondary | Change From Baseline in Evening Peak Expiratory Flow (PEF) During Weeks 1-24 | The peak expiratory flow rate measures how fast a person can (exhale) air. Then compares it to normal flow rates to predict obstruction and disease. The average PEF for a child or adolescent whose height is 43" is 147 L/min, whose height is 66" is 454 L/min. | Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data. | Posted | Mean | Standard Deviation | L/min | Baseline and during Weeks 1-24 |
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| Secondary | Change From Baseline in Circadian Variation in Peak Expiratory Flow (PEF) During Weeks 1-24 | Circadian Variation means the various changes in a day. The peak expiratory flow rate measures how fast a person can (exhale) air using a mini-Wright peak flow meter. The average PEF for a child or adolescent whose height is 43" is 147 L/min, whose height is 66" is 454 L/min. | Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data. | Posted | Mean | Standard Deviation | Percent Change | Baseline and during Weeks 1-24 |
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| Secondary | Number of Participants With Symptom-Free Nights and Days | Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data. | Posted | Number | Participants | Baseline and Week 24 |
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| Secondary | Number of Participants With Rescue Medication-Free Nights and Days | Rescue free means without the use of other medication. | Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data. | Posted | Number | Participants | Baseline and Week 24 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Salmeterol/Fluticasone Propionate | Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg) | 1 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Laryngopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA | Systematic Assessment |
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| Otitis Media | Infections and infestations | MedDRA | Systematic Assessment |
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| Pharyngotonsillitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Laryngotracheo bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Molluscum contagiosum | Infections and infestations | MedDRA | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
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| Sinusitus | Infections and infestations | MedDRA | Systematic Assessment |
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| tonsillitus | Infections and infestations | MedDRA | Systematic Assessment |
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| Acetonaemic vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Heat Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centres of a multi-centre trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| Title | Measurements |
|---|---|
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| Asthma |
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| Pharyngitis |
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| Pyrexia |
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| Otitis media |
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| Pharyngotonsillitis |
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| Laryngotracheo bronchitis |
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| Molluscum contagiosum |
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| Stomatitis |
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