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| Study Type: | Interventional |
|---|---|
| Study Design: | Randomized, Open Label, Crossover Assignment |
| Condition: |
Bronchial Asthma |
| Interventions: |
Drug: GW815SF HFA MDI Drug: salmeterol and fluticasone propionate |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| No text entered. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
| Description | |
|---|---|
| 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). |
| 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). |
| SFC 50/100 Mcg/Day First | SLM 50 Mcg + FP 100 Mcg/Day First | |
|---|---|---|
| STARTED | 26 | 25 |
| COMPLETED | 26 | 25 |
| NOT COMPLETED | 0 | 0 |
| SFC 50/100 Mcg/Day First | SLM 50 Mcg + FP 100 Mcg/Day First | |
|---|---|---|
| STARTED | 26 | 25 |
| COMPLETED | 25 | 25 |
| NOT COMPLETED | 1 | 0 |
| Withdrawal by Subject | 1 | 0 |
| SFC 50/100 Mcg/Day First | SLM 50 Mcg + FP 100 Mcg/Day First | |
|---|---|---|
| STARTED | 25 | 25 |
| COMPLETED | 25 | 25 |
| NOT COMPLETED | 0 | 0 |
| SFC 50/100 Mcg/Day First | SLM 50 Mcg + FP 100 Mcg/Day First | |
|---|---|---|
| STARTED | 50 | 0 |
| COMPLETED | 50 | 0 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Description | |
|---|---|
| Overall Study Population | Randomized Population |
| Overall Study Population | |
|---|---|
|
Number of Participants [units: participants] |
51 |
|
Age [units: Years] Mean ± Standard Deviation |
8.3 ± 2.41 |
|
Gender [units: participants] |
|
| Female | 17 |
| Male | 34 |
|
Race/Ethnicity, Customized [units: Participants] |
|
| Asian-Japanese Heritage | 51 |
|
Region of Enrollment [units: participants] |
|
| Japan | 51 |
Outcome Measures
| 1. Primary: | Adjusted Mean Change From Baseline in Morning PEF (Peak Expiratory Flow) During the 4-week Treatment Periods [ Crossover Period Weeks 1-4, and 7-10 ] |
| 2. Secondary: | Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 4-week Treatment Periods [ Crossover Period Weeks 1-4, 7-10 ] |
| 3. Secondary: | Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 4-week Treatment Periods [ Crossover Period weeks 1-4, 7-10 ] |
| 4. Secondary: | Adjusted Mean Change From Baseline in Evening PEF During the 4-week Treatment Periods [ Crossover Period weeks 1-4, 7-10 ] |
| 5. Secondary: | Adjusted Mean Change From Baseline of Circadian Variation in Morning PEF(%) During the 4-week Treatment Periods [ Crossover Period Weeks 1-4, 7-10 ] |
| 6. Secondary: | Percentage of Subjects With Symptom-Free Nights & Days [ Crossover Period Week 1-4, 7-10 ] |
| 7. Secondary: | Percentage of Subjects With Rescue Medication-Free Nights and Days [ Crossover Period Weeks 1-4, 7-10 ] |
| 8. Secondary: | Adjusted Mean Change From Baseline in Morning PEF During the 20-week Extension Treatment Period [ Extension Period Weeks 11-30 ] |
| 9. Secondary: | Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 20-Week Extension Treatment Period [ Extension Period weeks 11-30 ] |
| 10. Secondary: | Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 20-week Extension Treatment Period [ Extension Period weeks 11-30 ] |
| 11. Secondary: | Adjusted Mean Change From Baseline in Evening PEF During the 20-week Extension Treatment Period [ Extension Period weeks 11-30 ] |
| 12. Secondary: | Adjusted Mean Change From Baseline of Circadian Variation in PEF(%) During the 20-Week Extension Treatment Period [ Extension Period weeks 11-30 ] |
| 13. Secondary: | Percentage of Subjects With Symptom-Free Nights & Days After 20 Weeks of Treatment [ Extension Period Weeks 11-30 ] |
| 14. Secondary: | Percentage of Subjects With Rescue Medication-Free Nights & Days After 20 Weeks of Treatment [ Extension Period Weeks 11-30 ] |