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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| SFC | Experimental | SFC (salmeterol/fluticasone propionate combination) 25/50mcg twice daily in Extension period (after cross-over period). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW815SF HFA MDI | Drug | salmeterol and fluticasone propionate combination |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change From Baseline in Morning PEF (Peak Expiratory Flow) During the 4-week Treatment Periods | Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out (i.e., the last 7 days prior to the day of starting treatment period [Weeks 1-4/Weeks 7-10]). | Crossover Period Weeks 1-4, and 7-10 |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 4-week Treatment Periods | Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out. | Crossover Period Weeks 1-4, 7-10 |
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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 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:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Chiba | 260-0001 | Japan | |||
| GSK Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | SFC 50/100 Mcg/Day First | GW815SF (SFC; Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily in first intervention period and SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg + FP (Fluticasone Propionate) DPI 50 mcg twice daily in second intervention period (after washout period). |
| FG001 | SLM 50 Mcg + FP 100 Mcg/Day First | SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg + FP (Fluticasone Propionate) DPI 50 mcg twice daily in first intervention period and GW815SF (SFC; Salmeterol/Fluticasone Propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily in second intervention period (after washout period). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period I - 4 Weeks |
| |||||||||||||
| Washout Period - 2 Weeks |
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| Treatment Period II - 4 Weeks |
| |||||||||||||
| Extension Period - 20 Weeks |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Population | Randomized Population |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Adjusted Mean Change From Baseline in Morning PEF (Peak Expiratory Flow) During the 4-week Treatment Periods | Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out (i.e., the last 7 days prior to the day of starting treatment period [Weeks 1-4/Weeks 7-10]). | PPS (Per Protocol Set): randomized subjects less those who did not complete treatment. | Posted | Mean | Standard Error | Liters/minute | Crossover Period Weeks 1-4, and 7-10 |
|
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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 | SFC 50/100 Mcg/Day | Safety Population who received GW815SF (SFC, Salmeterol/Fluticasone Propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily in Crossover Period Weeks 1-4 and 7-10 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000068297 | Fluticasone-Salmeterol Drug Combination |
| ID | Term |
|---|---|
| D000068299 | Salmeterol Xinafoate |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
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| salmeterol and fluticasone propionate | Drug | salmeterol + fluticasone propionate |
|
| Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 4-week Treatment Periods | Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out. | Crossover Period weeks 1-4, 7-10 |
| Adjusted Mean Change From Baseline in Evening PEF During the 4-week Treatment Periods | Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out. | Crossover Period weeks 1-4, 7-10 |
| Adjusted Mean Change From Baseline of Circadian Variation in Morning PEF(%) During the 4-week Treatment Periods | Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out. | Crossover Period Weeks 1-4, 7-10 |
| Percentage of Subjects With Symptom-Free Nights & Days | Percentage of subjects with Symptom Free Nights & Days after 4 weeks of Treatment | Crossover Period Week 1-4, 7-10 |
| Percentage of Subjects With Rescue Medication-Free Nights and Days | Percentage of subjects with Rescue Medication Free Nights & Days after 4 weeks of Treatment | Crossover Period Weeks 1-4, 7-10 |
| Adjusted Mean Change From Baseline in Morning PEF During the 20-week Extension Treatment Period | Mean change from baseline = value at assessment period (mean of the values obtained at assessment period (Weeks 11-30).) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting of the Extension period (Weeks 11-30). | Extension Period Weeks 11-30 |
| Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 20-Week Extension Treatment Period | Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30). | Extension Period weeks 11-30 |
| Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 20-week Extension Treatment Period | Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30). | Extension Period weeks 11-30 |
| Adjusted Mean Change From Baseline in Evening PEF During the 20-week Extension Treatment Period | Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30). | Extension Period weeks 11-30 |
| Adjusted Mean Change From Baseline of Circadian Variation in PEF(%) During the 20-Week Extension Treatment Period | Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30). | Extension Period weeks 11-30 |
| Percentage of Subjects With Symptom-Free Nights & Days After 20 Weeks of Treatment | Percentage of subjects with Symptom Free Nights & Days after 20 weeks of Treatment (at week 30). | Extension Period Weeks 11-30 |
| Percentage of Subjects With Rescue Medication-Free Nights & Days After 20 Weeks of Treatment | Percentage of subjects with Rescue Medication Free Nights & Days after 20 weeks of Treatment (at week 30). | Extension Period Weeks 11-30 |
| Kanagawa |
| 245-0018 |
| Japan |
| GSK Investigational Site | Saitama | 360-0018 | Japan |
| GSK Investigational Site | Saitama | 360-0812 | Japan |
| GSK Investigational Site | Tokyo | 154-0002 | Japan |
| GSK Investigational Site | Tokyo | 154-0017 | Japan |
| GSK Investigational Site | Tokyo | 158-0083 | Japan |
| GSK Investigational Site | Tokyo | 158-0097 | Japan |
| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| SLM 50 Mcg + FP 100 Mcg/Day |
Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily |
|
|
|
| Secondary | Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 4-week Treatment Periods | Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out. | PPS | Posted | Mean | Standard Error | Percentage of predicted value | Crossover Period Weeks 1-4, 7-10 |
|
|
|
| Secondary | Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 4-week Treatment Periods | Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out. | PPS | Posted | Mean | Standard Error | Percentage of personal best value | Crossover Period weeks 1-4, 7-10 |
|
|
|
| Secondary | Adjusted Mean Change From Baseline in Evening PEF During the 4-week Treatment Periods | Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out. | PPS | Posted | Mean | Standard Error | L/min | Crossover Period weeks 1-4, 7-10 |
|
|
|
| Secondary | Adjusted Mean Change From Baseline of Circadian Variation in Morning PEF(%) During the 4-week Treatment Periods | Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out. | PPS | Posted | Mean | Standard Error | Percentage of circadian variation | Crossover Period Weeks 1-4, 7-10 |
|
|
|
| Secondary | Percentage of Subjects With Symptom-Free Nights & Days | Percentage of subjects with Symptom Free Nights & Days after 4 weeks of Treatment | PPS | Posted | Number | Percent of participants | Crossover Period Week 1-4, 7-10 |
|
|
|
| Secondary | Percentage of Subjects With Rescue Medication-Free Nights and Days | Percentage of subjects with Rescue Medication Free Nights & Days after 4 weeks of Treatment | PPS | Posted | Number | Percentage of participants | Crossover Period Weeks 1-4, 7-10 |
|
|
|
| Secondary | Adjusted Mean Change From Baseline in Morning PEF During the 20-week Extension Treatment Period | Mean change from baseline = value at assessment period (mean of the values obtained at assessment period (Weeks 11-30).) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting of the Extension period (Weeks 11-30). | FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI. | Posted | Mean | Standard Deviation | L/min | Extension Period Weeks 11-30 |
|
|
|
| Secondary | Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 20-Week Extension Treatment Period | Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30). | FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI. | Posted | Mean | Standard Deviation | Percentage of predicted value | Extension Period weeks 11-30 |
|
|
|
| Secondary | Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 20-week Extension Treatment Period | Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30). | FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI. | Posted | Mean | Standard Deviation | Percentage of personal best value | Extension Period weeks 11-30 |
|
|
|
| Secondary | Adjusted Mean Change From Baseline in Evening PEF During the 20-week Extension Treatment Period | Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30). | FAS (Full Analysis Set) during the Exension period: all subjects switched to Extension period and received GW815SF HFA MDI. | Posted | Mean | Standard Deviation | L/Min | Extension Period weeks 11-30 |
|
|
|
| Secondary | Adjusted Mean Change From Baseline of Circadian Variation in PEF(%) During the 20-Week Extension Treatment Period | Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30). | FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI. | Posted | Mean | Standard Deviation | Percentage of circadian variation | Extension Period weeks 11-30 |
|
|
|
| Secondary | Percentage of Subjects With Symptom-Free Nights & Days After 20 Weeks of Treatment | Percentage of subjects with Symptom Free Nights & Days after 20 weeks of Treatment (at week 30). | FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI. | Posted | Number | Percentage of participants | Extension Period Weeks 11-30 |
|
|
|
| Secondary | Percentage of Subjects With Rescue Medication-Free Nights & Days After 20 Weeks of Treatment | Percentage of subjects with Rescue Medication Free Nights & Days after 20 weeks of Treatment (at week 30). | FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI. | Posted | Number | Percentage of participants | Extension Period Weeks 11-30 |
|
|
|
| 0 |
| 51 |
| 12 |
| 51 |
| EG001 | SLM 50 + FP 100 Mcg/Day | Safety Population who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily in Crossover Period Weeks 1-4 and 7-10 | 0 | 50 | 10 | 50 |
| EG002 | SFC 50/100mcg/Day (Extension Period) | Safety Population who switched to Extension Period and received GW815SF HFA MDI 25/50mcg twice daily during the Extension period | 0 | 51 | 35 | 51 |
| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit an investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not preceed the primary publication of the entire clinical trial.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000438 |
| Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000068298 | Fluticasone |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |