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Clinical Assessment Of GW815SF HFA MDI In Pediatric Patients With Bronchial Asthma
This study has been completed.
Study NCT00448435   Information provided by GlaxoSmithKline
First Received: March 14, 2007   Last Updated: October 30, 2009   History of Changes
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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  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).

Participant Flow for 4 periods

Period:   Treatment Period I - 4 Weeks
  SFC 50/100 Mcg/Day First SLM 50 Mcg + FP 100 Mcg/Day First
STARTED   26     25  
COMPLETED   26     25  
NOT COMPLETED   0     0  

Period:   Washout Period - 2 Weeks
  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  

Period:   Treatment Period II - 4 Weeks
  SFC 50/100 Mcg/Day First SLM 50 Mcg + FP 100 Mcg/Day First
STARTED   25     25  
COMPLETED   25     25  
NOT COMPLETED   0     0  

Period:   Extension Period - 20 Weeks
  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
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Reporting Groups
  Description
Overall Study Population Randomized Population

Baseline Measures
  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
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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 ]


  Serious Adverse Events
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  Other Adverse Events
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