Text Size

Fall Epidemic Viral Pediatric Study

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01192178
First received: July 15, 2010
Last updated: November 17, 2011
Last verified: November 2011
History of Changes
Results First Received: September 29, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: FLOVENT™ DISKUS™ 100 mcg BID
Drug: ADVAIR™ DISKUS™ 100/50 mcg BID

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
FSC DISKUS 100/50 Mcg BID Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) at a dose of 100/50 micrograms (mcg) administered as one inhalation twice daily (BID) for 16 weeks
FP DISKUS 100 Mcg BID Fluticasone Propionate (FP) DISKUS 100 mcg administered as one inhalation BID for 16 weeks

Participant Flow:   Overall Study
    FSC DISKUS 100/50 Mcg BID     FP DISKUS 100 Mcg BID  
STARTED     171     168  
COMPLETED     147     145  
NOT COMPLETED     24     23  
Withdrawal by Subject                 6                 10  
Protocol Violation                 10                 3  
Physician Decision                 2                 4  
Lost to Follow-up                 3                 3  
Adverse Event                 2                 1  
Lack of Efficacy                 1                 2  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
FSC DISKUS 100/50 Mcg BID Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) at a dose of 100/50 micrograms (mcg) administered as one inhalation twice daily (BID) for 16 weeks
FP DISKUS 100 Mcg BID Fluticasone Propionate (FP) DISKUS 100 mcg administered as one inhalation BID for 16 weeks
Total Total of all reporting groups

Baseline Measures
    FSC DISKUS 100/50 Mcg BID     FP DISKUS 100 Mcg BID     Total  
Number of Participants  
[units: participants]
 		  171     168     339  
Age  
[units: Years]
Mean ± Standard Deviation 		  7.5  ± 2.11     7.4  ± 2.08     7.4  ± 2.09  
Gender  
[units: Participants]
 		     
Female     63     56     119  
Male     108     112     220  
Race/Ethnicity, Customized  
[units: participants]
 		     
African American/African Heritage     27     33     60  
American Indian or Alaska Native     2     0     2  
Asian     8     6     14  
American Indian or Alaska Native and White     1     0     1  
White     129     127     256  
African American/African Heritage and White     1     1     2  
Asian & Native Hawaiian or Other Pacific Islander     1     0     1  
Asian and White     2     0     2  
Native Hawaiian or Other Pacific Islander & White     0     1     1  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Total Number of Asthma Exacerbations Reported During the Treatment Period   [ Time Frame: From Baseline (Week 1) until the end of treatment (up to Week 16) ]
  Show Outcome Measure 1

2.  Secondary:   Mean Asthma Symptom Scores, as an Indicator of Severity, Associated With the Presence of Moderate or Severe Upper Respiratory Tract Symptoms (URTS) or a Confirmed Rhinovirus (RV) Infection at Baseline and During the Peak Viral Period   [ Time Frame: Baseline (Week 1) and Peak Viral Period ([period during which the greatest number of viral infections is expected] from 30 August 2010 through the end of the treatment period [up to Week 16]) ]
  Show Outcome Measure 2

3.  Secondary:   Mean Duration of Worsening Asthma Symptoms Associated With the Presence of Moderate or Severe URTS or a Confirmed RV Infection   [ Time Frame: Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16]) ]
  Show Outcome Measure 3

4.  Secondary:   Number of Asthma Exacerbations Associated With the Presence of Moderate or Severe URTS or a Confirmed RV Infection During the Peak Viral Period   [ Time Frame: Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16]) ]
  Show Outcome Measure 4

5.  Secondary:   Mean Percentage of Asthma-control Days   [ Time Frame: Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16]) ]
  Show Outcome Measure 5

6.  Secondary:   Mean Percentage of Episode-free (EF) Days   [ Time Frame: Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16]) ]
  Show Outcome Measure 6

7.  Secondary:   Mean Percentage of Symptom-free Days   [ Time Frame: Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16]) ]
  Show Outcome Measure 7

8.  Secondary:   Mean Percentage of Rescue-free Days   [ Time Frame: Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16]) ]
  Show Outcome Measure 8


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Show More Information