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Best African American Response to Asthma Drugs (BARD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01967173
Recruitment Status : Completed
First Posted : October 22, 2013
Results First Posted : November 15, 2018
Last Update Posted : November 15, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
dave mauger, Milton S. Hershey Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: Flovent Diskus® 100 mcg
Drug: Flovent Diskus® 250 mcg
Drug: Flovent Diskus® 500 mcg
Drug: Advair Diskus® 100/50 mcg
Drug: Advair Diskus® 250/50 mcg
Enrollment 574
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Crossover Sequence 1 Crossover Sequence 2 Crossover Sequence 3 Crossover Sequence 4 Crossover Sequence 5 Crossover Sequence 6 Crossover Sequence 7 Crossover Sequence 8
Hide Arm/Group Description

Flovent Diskus® 250 mcg,followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 100 mcg, followed by Advair Diskus® 100/50 mcg

Flovent Diskus® 100 mcg: Flovent is an ICS

Flovent Diskus® 250 mcg: Flovent is an ICS

Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination

Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination

Advair Diskus® 250/50 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Flovent Diskus® 100 mcg

Flovent Diskus® 100 mcg: Flovent is an ICS

Flovent Diskus® 250 mcg: Flovent is an ICS

Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination

Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination

Flovent Diskus® 100 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 100/50 mcg, followed by Advair Diskus® 250/50 mcg

Flovent Diskus® 100 mcg: Flovent is an ICS

Flovent Diskus® 250 mcg: Flovent is an ICS

Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination

Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination

Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 100 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 250 mcg

Flovent Diskus® 100 mcg: Flovent is an ICS

Flovent Diskus® 250 mcg: Flovent is an ICS

Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination

Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination

Flovent Diskus® 500 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 100/50 mcg

Flovent Diskus® 250 mcg: Flovent is an ICS

Flovent Diskus® 500 mcg: Flovent is an ICS

Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination

Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination

Advair Diskus® 250/50 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 500 mcg, followed by Flovent Diskus® 250 mcg

Flovent Diskus® 250 mcg: Flovent is an ICS

Flovent Diskus® 500 mcg: Flovent is an ICS

Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination

Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination

Flovent Diskus® 250 mcg, followed by Flovent Diskus® 500 mcg, followed by Advair Diskus® 100/50 mcg, followed by Advair Diskus® 250/50 mcg

Flovent Diskus® 250 mcg: Flovent is an ICS

Flovent Diskus® 500 mcg: Flovent is an ICS

Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination

Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination

Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 500 mcg

Flovent Diskus® 250 mcg: Flovent is an ICS

Flovent Diskus® 500 mcg: Flovent is an ICS

Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination

Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination

Period Title: Overall Study
Started 69 69 71 71 73 72 75 74
Completed 1st Period 58 60 67 65 64 62 67 69
Completed 2nd Period 52 58 63 62 63 57 63 61
Completed 3rd Period 48 54 60 61 59 56 59 56
Completed 4th Period 45 52 55 57 56 49 57 50
Completed 45 52 55 57 56 49 57 50
Not Completed 24 17 16 14 17 23 18 24
Reason Not Completed
Lost to Follow-up             5             3             2             4             8             12             6             8
Physician Decision             2             0             2             1             1             1             1             0
Lack of Efficacy             2             0             2             2             0             1             0             2
Pregnancy             0             0             0             0             0             0             1             1
Adverse Event             0             0             0             0             0             0             0             1
Withdrawal by Subject             15             14             10             7             8             9             10             12
Arm/Group Title Crossover Sequence 1 Crossover Sequence 2 Crossover Sequence 3 Crossover Sequence 4 Crossover Sequence 5 Crossover Sequence 6 Crossover Sequence 7 Crossover Sequence 8 Total
Hide Arm/Group Description

Flovent Diskus® 250 mcg,followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 100 mcg, followed by Advair Diskus® 100/50 mcg

Flovent Diskus® 100 mcg: Flovent is an ICS

Flovent Diskus® 250 mcg: Flovent is an ICS

Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination

Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination

Advair Diskus® 250/50 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Flovent Diskus® 100 mcg

Flovent Diskus® 100 mcg: Flovent is an ICS

Flovent Diskus® 250 mcg: Flovent is an ICS

Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination

Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination

Flovent Diskus® 100 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 100/50 mcg, followed by Advair Diskus® 250/50 mcg

Flovent Diskus® 100 mcg: Flovent is an ICS

Flovent Diskus® 250 mcg: Flovent is an ICS

Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination

Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination

Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 100 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 250 mcg

Flovent Diskus® 100 mcg: Flovent is an ICS

Flovent Diskus® 250 mcg: Flovent is an ICS

Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination

Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination

Flovent Diskus® 500 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 100/50 mcg

Flovent Diskus® 250 mcg: Flovent is an ICS

Flovent Diskus® 500 mcg: Flovent is an ICS

Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination

Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination

Advair Diskus® 250/50 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 500 mcg, followed by Flovent Diskus® 250 mcg

Flovent Diskus® 250 mcg: Flovent is an ICS

Flovent Diskus® 500 mcg: Flovent is an ICS

Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination

Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination

Flovent Diskus® 250 mcg, followed by Flovent Diskus® 500 mcg, followed by Advair Diskus® 100/50 mcg, followed by Advair Diskus® 250/50 mcg

Flovent Diskus® 250 mcg: Flovent is an ICS

Flovent Diskus® 500 mcg: Flovent is an ICS

Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination

Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination

Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 500 mcg

Flovent Diskus® 250 mcg: Flovent is an ICS

Flovent Diskus® 500 mcg: Flovent is an ICS

Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination

Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination

Total of all reporting groups
Overall Number of Baseline Participants 69 69 71 71 73 72 75 74 574
Hide Baseline Analysis Population Description
All randomized participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 69 participants 69 participants 71 participants 71 participants 73 participants 72 participants 75 participants 74 participants 574 participants
8.7  (2.0) 8.5  (1.7) 8.4  (1.9) 8.4  (1.8) 38.5  (16.5) 38.5  (15.9) 39.3  (16.0) 35.6  (16.0) 23.2  (18.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 69 participants 71 participants 71 participants 73 participants 72 participants 75 participants 74 participants 574 participants
Female
29
  42.0%
27
  39.1%
26
  36.6%
28
  39.4%
52
  71.2%
48
  66.7%
47
  62.7%
52
  70.3%
309
  53.8%
Male
40
  58.0%
42
  60.9%
45
  63.4%
43
  60.6%
21
  28.8%
24
  33.3%
28
  37.3%
22
  29.7%
265
  46.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 69 participants 71 participants 71 participants 73 participants 72 participants 75 participants 74 participants 574 participants
Hispanic or Latino
7
  10.1%
4
   5.8%
7
   9.9%
6
   8.5%
2
   2.7%
2
   2.8%
2
   2.7%
3
   4.1%
33
   5.7%
Not Hispanic or Latino
62
  89.9%
65
  94.2%
64
  90.1%
65
  91.5%
71
  97.3%
70
  97.2%
73
  97.3%
71
  95.9%
541
  94.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Black Number Analyzed 69 participants 69 participants 71 participants 71 participants 73 participants 72 participants 75 participants 74 participants 574 participants
63
  91.3%
65
  94.2%
68
  95.8%
66
  93.0%
69
  94.5%
71
  98.6%
74
  98.7%
73
  98.6%
549
  95.6%
Other Number Analyzed 69 participants 69 participants 71 participants 71 participants 73 participants 72 participants 75 participants 74 participants 574 participants
6
   8.7%
4
   5.8%
3
   4.2%
5
   7.0%
4
   5.5%
1
   1.4%
1
   1.3%
1
   1.4%
25
   4.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 69 participants 69 participants 71 participants 71 participants 73 participants 72 participants 75 participants 74 participants 574 participants
69 69 71 71 73 72 75 74 574
Forced expiratory volume at one second (FEV1) Percent of Predicted   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 69 participants 69 participants 71 participants 71 participants 73 participants 72 participants 75 participants 74 participants 574 participants
98.1  (15.4) 92.6  (17.9) 95  (13.6) 96.2  (19.1) 83.8  (19.1) 82.9  (15.5) 83.7  (17.3) 83.4  (18) 89.3  (18.1)
[1]
Measure Description: FEV1, expressed as percent of predicted FEV1 based on age, sex, race, and height.
Asthma Control Test   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 0 participants 0 participants 0 participants 0 participants 73 participants 72 participants 75 participants 74 participants 294 participants
18.9  (3.8) 18.6  (3.9) 19.2  (3.7) 18.8  (3.8) 18.9  (3.8)
[1]
Measure Description: Asthma Control Test: The score is calculated as the sum total of a 5-item questionnaire. Each item ranges from 1 (poor control) to 5 (good control) so that the range of the total score is 5 to 25. Scores below 20 indicate that asthma is not well controlled.
[2]
Measure Analysis Population Description: Asthma Control Test is not validated for use in children
Childhood Asthma Control Test   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 69 participants 69 participants 71 participants 71 participants 0 participants 0 participants 0 participants 0 participants 280 participants
21.5  (3.7) 21.2  (3.6) 20.7  (4.1) 22.1  (3.6) 21.4  (3.8)
[1]
Measure Description: Childhood Asthma Control Test is for children 4-11 years of age: The score is calculated as the sum total of a 7-item questionnaire. Four items ranges from 0 (poor control) to 3 (good control) and three items ranges from 0 (poor control) to 5 (good control) so so that the range of the total score is 0 to 27. Scores below 20 indicate that asthma is not well controlled.
[2]
Measure Analysis Population Description: Childhood Asthma Control Test is not validated for use in adults
1.Primary Outcome
Title The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen.
Hide Description This composite outcome uses a hierarchical method to ascertain differences in asthma control. For each participant, treatments are first compared to see if they differ in terms of exacerbations. If one treatment results in fewer exacerbations than another, it is deemed the superior treatment and no further comparisons are made. If treatment superiority cannot be assigned by exacerbations, then they are compared by asthma control days (ACDs). If one treatment yields at least 31 annualized ACDs more than another, it is deemed the superior treatment. If treatment superiority still cannot be assigned by ACDs, then they are compared by percent predicted FEV1 at the end of a treatment period. If one treatment yields at least 5% greater FEV1 than another, it is deemed the superior treatment. If treatment superiority cannot be assigned by exacerbations, ACDs or FEV1, then that participant is classified as having no differential response.
Time Frame The last 12 weeks of each 14-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Not all treatments were used in all participants. Flovent 500 was not used in children and Flovent 100 was not used in adolescents and adults
Arm/Group Title Adolescents and Adults Children
Hide Arm/Group Description:
All study participant age 12 years or greater
All study participants under age 12 years
Overall Number of Participants Analyzed 294 280
Measure Type: Number
Unit of Measure: probability
Advair 100/50 superior to Flovent 250 Number Analyzed 294 participants 280 participants
.49 .46
Advair 100/50 inferior to Flovent 250 Number Analyzed 294 participants 280 participants
.28 .46
Advair 100/50 superior to Flovent 500 Number Analyzed 294 participants 0 participants
.53
Advair 100/50 inferior to Flovent 500 Number Analyzed 294 participants 0 participants
.27
Advair 100/50 superior to Advair 250/50 Number Analyzed 294 participants 280 participants
.42 .47
Advair 100/50 inferior to Advair 250/50 Number Analyzed 294 participants 280 participants
.36 .49
Advair 100/50 superior to Flovent 100 Number Analyzed 0 participants 280 participants
.53
Advair 100/50 inferior to Flovent 100 Number Analyzed 0 participants 280 participants
.41
Advair 250/50 superior to Flovent 250 Number Analyzed 294 participants 280 participants
.46 .43
Advair 250/50 inferior to Flovent 250 Number Analyzed 294 participants 280 participants
.33 .47
Advair 250/50 superior to Flovent 500 Number Analyzed 294 participants 0 participants
.49
Advair 250/50 inferior to Flovent 500 Number Analyzed 294 participants 0 participants
.31
Flovent 500 superior to Flovent 250 Number Analyzed 294 participants 0 participants
.35
Flovent 500 inferior to Flovent 250 Number Analyzed 294 participants 0 participants
.40
Flovent 250 superior to Flovent 100 Number Analyzed 0 participants 280 participants
.51
Flovent 250 inferior to Flovent 100 Number Analyzed 0 participants 280 participants
.37
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adolescents and Adults
Comments Test of the null hypothesis that the superiority of Advair 100/50 compared to Fluticasone 250 is equal to the inferiority of Advair 100/50 compared to Fluticasone 250
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Children
Comments Test of the null hypothesis that the superiority of Advair 100/50 compared to Fluticasone 250 is equal to the inferiority of Advair 100/50 compared to Fluticasone 250
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Adolescents and Adults
Comments Test of the null hypothesis that the superiority of Advair 100/50 compared to Fluticasone 500 is equal to the inferiority of Advair 100/50 compared to Fluticasone 500
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Adolescents and Adults
Comments Test of the null hypothesis that the superiority of Advair 100/50 compared to Advair 250/50 is equal to the inferiority of Advair 100/50 compared to Advair 250/50
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.42
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Children
Comments Test of the null hypothesis that the superiority of Advair 100/50 compared to Advair 250/50 is equal to the inferiority of Advair 100/50 compared to Advair 250/50
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.84
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Adolescents and Adults
Comments Test of the null hypothesis that the superiority of Advair 250/50 compared to Fluticasone 500 is equal to the inferiority of Advair 250/50 compared to Fluticasone 500
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Adolescents and Adults
Comments Test of the null hypothesis that the superiority of Advair 250/50 compared to Fluticasone 250 is equal to the inferiority of Advair 250/50 compared to Fluticasone 250
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.085
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Children
Comments Test of the null hypothesis that the superiority of Advair 250/50 compared to Fluticasone 250 is equal to the inferiority of Advair 250/50 compared to Fluticasone 250
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.62
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Adolescents and Adults
Comments Test of the null hypothesis that the superiority of Fluticasone 500 compared to Fluticasone 250 is equal to the inferiority of Fluticasone 500 compared to Fluticasone 250
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Children
Comments Test of the null hypothesis that the superiority of Advair 100/50 compared to Fluticasone 100 is equal to the inferiority of Advair 100/50 compared to Fluticasone 100
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Children
Comments Test of the null hypothesis that the superiority of Fluticasone 250 compared to Fluticasone 100 is equal to the inferiority of Fluticasone 250 compared to Fluticasone 100
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.096
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Flovent 250 in Pediatric Group Advair 250/50 in Pediatric Group Flovent 100 in Pediatric Group Advair 100/50 in Pediatric Group Flovent 500 in Adolescent/Adult Group Advair 250/50 in Adolescent/Adult Group Flovent 250 in Adolescent/Adult Group Advair 100/50 in Adolescent/Adult Group
Hide Arm/Group Description Flovent 250 in participants under 12 years Advair 250/50 in participants under 12 years Flovent 100 in participants under 12 years Advair 100/50 in participants under 12 years Flovent 500 in participants 12 years and older Advair 250/50 in participants 12 years and older Flovent 250 in participants 12 years and older Advair 100/50 in participants 12 years and older
All-Cause Mortality
Flovent 250 in Pediatric Group Advair 250/50 in Pediatric Group Flovent 100 in Pediatric Group Advair 100/50 in Pediatric Group Flovent 500 in Adolescent/Adult Group Advair 250/50 in Adolescent/Adult Group Flovent 250 in Adolescent/Adult Group Advair 100/50 in Adolescent/Adult Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/280 (0.00%)      0/280 (0.00%)      0/280 (0.00%)      0/280 (0.00%)      0/294 (0.00%)      0/294 (0.00%)      0/294 (0.00%)      0/294 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Flovent 250 in Pediatric Group Advair 250/50 in Pediatric Group Flovent 100 in Pediatric Group Advair 100/50 in Pediatric Group Flovent 500 in Adolescent/Adult Group Advair 250/50 in Adolescent/Adult Group Flovent 250 in Adolescent/Adult Group Advair 100/50 in Adolescent/Adult Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/280 (2.86%)      1/280 (0.36%)      2/280 (0.71%)      4/280 (1.43%)      10/294 (3.40%)      7/294 (2.38%)      7/294 (2.38%)      8/294 (2.72%)    
Blood and lymphatic system disorders                 
Anemia * 1  0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 0/294 (0.00%)  0 0/294 (0.00%)  0 1/294 (0.34%)  1 0/294 (0.00%)  0
Cardiac disorders                 
Acute Pericarditis * 1  0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 0/294 (0.00%)  0 0/294 (0.00%)  0 1/294 (0.34%)  1 0/294 (0.00%)  0
Gastrointestinal disorders                 
Acute Gastritis * 1  0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 1/294 (0.34%)  1 0/294 (0.00%)  0 0/294 (0.00%)  0 0/294 (0.00%)  0
Acute Peptic Ulcer * 1  0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 1/294 (0.34%)  1 0/294 (0.00%)  0 0/294 (0.00%)  0 0/294 (0.00%)  0
Chest Pain Not Elsewhere Classified * 1  0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 1/294 (0.34%)  1 0/294 (0.00%)  0 0/294 (0.00%)  0 0/294 (0.00%)  0
General disorders                 
Convulsions Not Elsewhere Classified * 1  1/280 (0.36%)  1 0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 0/294 (0.00%)  0 0/294 (0.00%)  0 0/294 (0.00%)  0 0/294 (0.00%)  0
Syncope and Collapse * 1  0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 0/294 (0.00%)  0 1/294 (0.34%)  1 0/294 (0.00%)  0 0/294 (0.00%)  0
Injury, poisoning and procedural complications                 
Adverse Food Reaction * 1  0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 0/294 (0.00%)  0 1/294 (0.34%)  1 0/294 (0.00%)  0 0/294 (0.00%)  0
Anaphylactic Shock * 1  0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 0/294 (0.00%)  0 1/294 (0.34%)  1 1/294 (0.34%)  1 0/294 (0.00%)  0
Closed Fracture * 1  0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 1/280 (0.36%)  1 0/294 (0.00%)  0 0/294 (0.00%)  0 0/294 (0.00%)  0 0/294 (0.00%)  0
Musculoskeletal and connective tissue disorders                 
Lumbar Spinal Cord Compression * 1  0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 1/294 (0.34%)  1 0/294 (0.00%)  0 0/294 (0.00%)  0 0/294 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                 
Malignant Neoplasm Brain * 1  0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 1/294 (0.34%)  1 0/294 (0.00%)  0 0/294 (0.00%)  0 0/294 (0.00%)  0
Malignant Neoplasm Thyroid * 1  0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 0/294 (0.00%)  0 1/294 (0.34%)  1 0/294 (0.00%)  0 0/294 (0.00%)  0
Nervous system disorders                 
Acute Post-Op Pain * 1  0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 0/294 (0.00%)  0 0/294 (0.00%)  0 0/294 (0.00%)  0 1/294 (0.34%)  1
Migraine * 1  0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 0/294 (0.00%)  0 0/294 (0.00%)  0 0/294 (0.00%)  0 1/294 (0.34%)  1
Psychiatric disorders                 
Major Depression * 1  0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 0/294 (0.00%)  0 0/294 (0.00%)  0 1/294 (0.34%)  1 1/294 (0.34%)  1
Drug Withdrawal * 1  0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 0/294 (0.00%)  0 0/294 (0.00%)  0 0/294 (0.00%)  0 1/294 (0.34%)  1
Intermittent Explosive Disorder * 1  0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 1/280 (0.36%)  1 0/294 (0.00%)  0 0/294 (0.00%)  0 0/294 (0.00%)  0 0/294 (0.00%)  0
Altered Mental Status * 1  0/280 (0.00%)  0 0/280 (0.00%)  0 1/280 (0.36%)  1 0/280 (0.00%)  0 0/294 (0.00%)  0 0/294 (0.00%)  0 0/294 (0.00%)  0 0/294 (0.00%)  0
Renal and urinary disorders                 
Acute Kidney Failure * 1  0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 0/294 (0.00%)  0 1/294 (0.34%)  1 0/294 (0.00%)  0 0/294 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                 
Asthma Exacerbation * 1  6/280 (2.14%)  6 1/280 (0.36%)  1 1/280 (0.36%)  1 2/280 (0.71%)  2 4/294 (1.36%)  4 2/294 (0.68%)  2 1/294 (0.34%)  1 3/294 (1.02%)  3
Pneumonia * 1  0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 1/294 (0.34%)  1 0/294 (0.00%)  0 2/294 (0.68%)  2 0/294 (0.00%)  0
Flu * 1  1/280 (0.36%)  1 0/280 (0.00%)  0 0/280 (0.00%)  0 0/280 (0.00%)  0 0/294 (0.00%)  0 0/294 (0.00%)  0 0/294 (0.00%)  0 1/294 (0.34%)  1
1
Term from vocabulary, ICD-9
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Flovent 250 in Pediatric Group Advair 250/50 in Pediatric Group Flovent 100 in Pediatric Group Advair 100/50 in Pediatric Group Flovent 500 in Adolescent/Adult Group Advair 250/50 in Adolescent/Adult Group Flovent 250 in Adolescent/Adult Group Advair 100/50 in Adolescent/Adult Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   64/280 (22.86%)      52/280 (18.57%)      43/280 (15.36%)      27/280 (9.64%)      53/294 (18.03%)      47/294 (15.99%)      35/294 (11.90%)      34/294 (11.56%)    
General disorders                 
Cough * 1  11/280 (3.93%)  20 10/280 (3.57%)  23 13/280 (4.64%)  24 15/280 (5.36%)  21 2/294 (0.68%)  2 3/294 (1.02%)  5 6/294 (2.04%)  7 3/294 (1.02%)  3
Fever * 1  10/280 (3.57%)  11 6/280 (2.14%)  8 16/280 (5.71%)  19 8/280 (2.86%)  10 4/294 (1.36%)  4 3/294 (1.02%)  3 0/294 (0.00%)  0 4/294 (1.36%)  5
Respiratory, thoracic and mediastinal disorders                 
Acute Nasopharyngitis * 1  20/280 (7.14%)  35 18/280 (6.43%)  36 19/280 (6.79%)  33 20/280 (7.14%)  39 24/294 (8.16%)  33 27/294 (9.18%)  46 20/294 (6.80%)  40 22/294 (7.48%)  42
Acute Upper Respiratory Tract Infection * 1  16/280 (5.71%)  25 10/280 (3.57%)  14 11/280 (3.93%)  16 11/280 (3.93%)  20 11/294 (3.74%)  19 11/294 (3.74%)  15 16/294 (5.44%)  24 13/294 (4.42%)  20
Asthma Exacerbation * 1  23/280 (8.21%)  41 20/280 (7.14%)  47 40/280 (14.29%)  54 18/280 (6.43%)  31 18/294 (6.12%)  20 17/294 (5.78%)  20 17/294 (5.78%)  22 18/294 (6.12%)  23
1
Term from vocabulary, ICD-9
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David Mauger
Organization: Penn State University
Phone: 717-531-7178
EMail: dmauger@psu.edu
Layout table for additonal information
Responsible Party: dave mauger, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01967173     History of Changes
Other Study ID Numbers: AsthmaNet 006
1U10HL098115 ( U.S. NIH Grant/Contract )
First Submitted: October 11, 2013
First Posted: October 22, 2013
Results First Submitted: September 10, 2018
Results First Posted: November 15, 2018
Last Update Posted: November 15, 2018