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Study Of Fluticasone Propionate/Salmeterol In Asthmatic Subjects
This study has been completed.
Study NCT00517634   Information provided by GlaxoSmithKline
First Received: August 16, 2007   Last Updated: July 23, 2009   History of Changes
Study Type: Interventional
Study Design: Randomized, Double-Blind, Parallel Assignment
Condition: Asthma
Intervention: Drug: fluticasone propionate/salmeterol

  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
Sequence 1: FP, SFC, Placebo Fluticasone Propionate (FP) 100 micrograms (mcg) twice daily (BID) in the first treatment period: Salmeterol/Fluticasone Propionate Combination (SFC) 50/100 mcg BID in the second treatment period: Placebo in the third treatment period
Sequence 2: Placebo, SFC, FP Placebo in the first treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the second treatment period: Flutucasone Propionate 100 mcg BID in the third treatment period
Sequence 3: SFC, FP, Placebo Salmeterol/Fluticasone Propionate 50/100 Combination mcg BID in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Placebo in the third treatment period
Sequence 4: SFC, Placebo, FP Salmeterol/Fluticasone Priopionate Combination 50/100 mcg BID in the first treatment period: Placebo in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period
Sequence 5: FP, Placebo, SFC Fluticasone Propionate 100 mcg BID in the first treatment period: Placebo in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period
Sequence 6: Placebo, FP, SFC Placebo in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Salmeterol/Fluticasone Priopionate Combination 50/100 mcg BID in the third treatment period

Participant Flow for 3 periods

Period:   First Treatment Period
  Sequence 1: FP, SFC, Placebo Sequence 2: Placebo, SFC, FP Sequence 3: SFC, FP, Placebo Sequence 4: SFC, Placebo, FP Sequence 5: FP, Placebo, SFC Sequence 6: Placebo, FP, SFC
STARTED   4     4     4     3     4     4  
COMPLETED   4     4     4     3     4     4  
NOT COMPLETED   0     0     0     0     0     0  

Period:   Second Treatment Period
  Sequence 1: FP, SFC, Placebo Sequence 2: Placebo, SFC, FP Sequence 3: SFC, FP, Placebo Sequence 4: SFC, Placebo, FP Sequence 5: FP, Placebo, SFC Sequence 6: Placebo, FP, SFC
STARTED   4     4     4     3     4     4  
COMPLETED   4     4     4     3     3     4  
NOT COMPLETED   0     0     0     0     1     0  
      Withdrawal by Subject               0                 0                 0                 0                 1                 0  

Period:   Third Treatment Period
  Sequence 1: FP, SFC, Placebo Sequence 2: Placebo, SFC, FP Sequence 3: SFC, FP, Placebo Sequence 4: SFC, Placebo, FP Sequence 5: FP, Placebo, SFC Sequence 6: Placebo, FP, SFC
STARTED   4     4     4     3     3     4  
COMPLETED   4     4     4     3     3     4  
NOT COMPLETED   0     0     0     0     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Overall Study Population Overall Study Population: participants in all three treatment periods

Baseline Measures
  Overall Study Population
Number of Participants  
[units: participants]
23
Age  
[units: years]
Mean ± Standard Deviation
36.6 ± 6.63
Gender  
[units: participants]
 
Female 9
Male 14
Race/Ethnicity, Customized  
[units: participants]
 
African American 2
Caucasion 21



  Outcome Measures
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1.  Primary:   Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-allergen Challenge on Day 35   [ 0-6 hours post allergen challenge, 10-11 hours post treatment, Day 35 ]

2.  Secondary:   Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post Allergen Challenge on Day 14   [ 0-6 hours, post allergen challenge, 1 hour post treatment, Day 14 ]


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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