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Trial record 35 of 73 for:    Peru | Panama

A Study to Evaluate the Effectiveness and Safety of MEDI-528 in Adults

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: NCT00968669
Recruitment Status : Completed
First Posted : August 31, 2009
Results First Posted : June 4, 2014
Last Update Posted : June 4, 2014
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Asthma
Interventions Biological: MEDI528 30 mg
Biological: MEDI528 100 mg
Biological: MEDI528 300 mg
Other: Placebo
Enrollment 329
Recruitment Details  
Pre-assignment Details A total of 329 participants was randomized into the study, but 2 participants (1 in the MEDI-528 30 mg arm and 1 in the MEDI-528 300 mg arm) were randomized by mistake as they were screen failures. Therefore, a total of 327 participants were correctly randomized into the study.
Arm/Group Title Placebo MEDI528 30 mg MEDI528 100 mg MEDI528 300 mg
Hide Arm/Group Description Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Period Title: Overall Study
Started 82 81 83 81
Completed 64 63 72 72
Not Completed 18 18 11 9
Reason Not Completed
Lost to Follow-up             5             2             1             4
Withdrawal by Subject             9             7             5             3
Pregnancy             0             0             2             0
AE             1             0             0             0
AE-TRANSITIONAL CELL TUMOR IN BLADDER             0             0             0             1
DID NOT MEET EXCLUSION CRITERIA             1             0             0             0
DUE TO REPEATED ASTHMA EXACERBATIONS             1             0             0             0
EARLY DISCONTINUED ON 10-DEC-2010             0             0             1             0
EARLY WITHDRAWAL             0             1             0             0
ERROR IN HADS ADMINISTRATION             0             0             1             0
INEGIBILITY TO PERFORM VISIT             1             0             0             0
PATIENT RECEIVE ORAL PREDNISONE             0             1             0             0
PATIENT WAS ENROLLED BY MISTAKE             0             1             0             0
PATIENT WAS RANDOMIZED BY MISTAKE             0             1             0             0
PATIENT WILL BE WORKING ABROAD             0             1             0             0
SPONSOR DECISION             0             1             0             0
SUBJECT COMPLETED SAFETY FOLLOW-UP             0             0             1             0
SUBJECT DID NOT MEET ACQ REQUIREMENT             0             1             0             0
SUBJECT INCARCERATED             0             1             0             0
SUBJECT WAS RANDOMIZED IN ERROR             0             1             0             0
WITHDRAWN DUE TO PREDNISONE USE             0             0             0             1
Arm/Group Title Placebo MEDI528 30 mg MEDI528 100 mg MEDI528 300 mg Total
Hide Arm/Group Description Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks Total of all reporting groups
Overall Number of Baseline Participants 82 81 83 81 327
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 82 participants 81 participants 83 participants 81 participants 327 participants
43.6  (11.6) 41.8  (11.1) 45.1  (11.6) 41.5  (12.3) 43.0  (11.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 81 participants 83 participants 81 participants 327 participants
Female
53
  64.6%
55
  67.9%
62
  74.7%
55
  67.9%
225
  68.8%
Male
29
  35.4%
26
  32.1%
21
  25.3%
26
  32.1%
102
  31.2%
1.Primary Outcome
Title Change at Day 92 From Baseline in Mean Asthma Control Questionnaire (ACQ) Scores (Intent-toTreat Analysis)
Hide Description Change at Day 92 from baseline (Day 1, prior to dosing) in mean ACQ scores in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.
Time Frame Day 92
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants randomized into the 30, 100, or 300 mg MEDI-528 (n=81, 83, or 81, respectively) or placebo (n=82) groups.
Arm/Group Title Placebo MEDI528 30 mg MEDI528 100 mg MEDI528 300 mg
Hide Arm/Group Description:
Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Overall Number of Participants Analyzed 82 81 83 81
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.23  (0.95) -1.10  (1.11) -1.26  (1.02) -1.31  (1.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.435
Comments [Not Specified]
Method ANOVA
Comments Missing mean ACQ scores at Day 92 was imputed by last observation carried forward
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.828
Comments [Not Specified]
Method ANOVA
Comments Missing mean ACQ scores at Day 92 was imputed by last observation carried forward
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MEDI528 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.628
Comments [Not Specified]
Method ANOVA
Comments Missing mean ACQ scores at Day 92 was imputed by last observation carried forward
2.Secondary Outcome
Title Weighted Asthma Exacerbation Rate Through Day 92 (Intent-to-Treat Analysis)
Hide Description Weighted asthma exacerbation rate (total number of exacerbation rate in each group per total duration of participant-year follow-up in each group) between Day 1 and Day 92 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject’s asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy.
Time Frame Days 1 - 92
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo)
Arm/Group Title Placebo MEDI528 30 mg MEDI528 100 mg MEDI528 300 mg
Hide Arm/Group Description:
Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Overall Number of Participants Analyzed 82 81 83 81
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Exacerbations per participant year
0.53
(0.27 to 0.96)
0.82
(0.47 to 1.33)
0.33
(0.13 to 0.68)
0.39
(0.17 to 0.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.271
Comments [Not Specified]
Method Pairwise Poisson Regression
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.319
Comments [Not Specified]
Method Pairwise Poisson Regression
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.502
Comments [Not Specified]
Method Pairwise Poisson Regression
Comments [Not Specified]
3.Secondary Outcome
Title Weighted Asthma Exacerbation Rate Through Day 176 (Intent-to-Treat Analysis)
Hide Description Weighted asthma exacerbation rate (total number of exacerbation rate in each group per total duration of participant-year follow-up in each group) between Day 1 and Day 176 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject’s asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy.
Time Frame Days 1 - 176
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo)
Arm/Group Title Placebo MEDI528 30 mg MEDI528 100 mg MEDI528 300 mg
Hide Arm/Group Description:
Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Overall Number of Participants Analyzed 82 81 83 81
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Exacerbations per participant year
0.58
(0.36 to 0.88)
0.64
(0.40 to 0.96)
0.28
(0.14 to 0.50)
0.58
(0.36 to 0.88)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.756
Comments [Not Specified]
Method Pairwise Poisson Regression
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments [Not Specified]
Method Pairwise Poisson Regression
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Pairwise Poisson Regression
Comments [Not Specified]
4.Secondary Outcome
Title Proportion of Participants Experiencing at Least One Asthma Exacerbation Through Day 92 (Intent-to-Treat Analysis)
Hide Description The proportion of participants that experienced at least one asthma exacerbation between Day 1 and Day 92 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject’s asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy.
Time Frame Days 1 - 92
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo)
Arm/Group Title Placebo MEDI528 30 mg MEDI528 100 mg MEDI528 300 mg
Hide Arm/Group Description:
Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Overall Number of Participants Analyzed 82 81 83 81
Measure Type: Number
Unit of Measure: Participants
8 14 5 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1764
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4031
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Proportion of Participants Experiencing at Least One Asthma Exacerbation Through Day 176 (Intent-to-Treat Analysis)
Hide Description The proportion of participants that experienced at least one asthma exacerbation between Day 1 and Day 176 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject’s asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy.
Time Frame Days 1 - 176
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo)
Arm/Group Title Placebo MEDI528 30 mg MEDI528 100 mg MEDI528 300 mg
Hide Arm/Group Description:
Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Overall Number of Participants Analyzed 82 81 83 81
Measure Type: Number
Unit of Measure: Participants
16 17 8 15
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8475
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0811
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
6.Secondary Outcome
Title Time to First Asthma Exacerbation Through Day 92 (Intent-to-Treat Analysis)
Hide Description Time to first asthma exacerbation between Day 1 and Day 92 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject’s asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy.
Time Frame Days 1 - 92
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo)
Arm/Group Title Placebo MEDI528 30 mg MEDI528 100 mg MEDI528 300 mg
Hide Arm/Group Description:
Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Overall Number of Participants Analyzed 82 81 83 81
Median (95% Confidence Interval)
Unit of Measure: Day
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Too few events; time to median time to first asthma exacerbation was not reached.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.144
Comments [Not Specified]
Method Log Rank
Comments Stratified by atopic asthma and steroid use
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.938
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.395
Comments [Not Specified]
Method Log Rank
Comments Stratified by atopic asthma status and steroid use
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.618
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.863
Comments [Not Specified]
Method Log Rank
Comments Stratified by atopic asthma status and steroid use
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.899
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Time to First Asthma Exacerbation Through Day 176 (Intent-to-Treat Analysis)
Hide Description Time to first asthma exacerbation between Day 1 and Day 176 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject’s asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy.
Time Frame Days 1 - 176
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo)
Arm/Group Title Placebo MEDI528 30 mg MEDI528 100 mg MEDI528 300 mg
Hide Arm/Group Description:
Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Overall Number of Participants Analyzed 82 81 83 81
Median (95% Confidence Interval)
Unit of Measure: Day
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Too few events; time to median time to first asthma exacerbation was not reached.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.717
Comments [Not Specified]
Method Log Rank
Comments Stratified by atopic asthma and steroid use
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.162
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.070
Comments [Not Specified]
Method Log Rank
Comments Stratified by atopic asthma status and steroid use
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.467
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.934
Comments [Not Specified]
Method Log Rank
Comments Stratified by atopic asthma status and steroid use
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.955
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change at Day 176 From Baseline in Mean Asthma Control Questionnaire Scores (Intent-to-Treat Analysis)
Hide Description Change at Day 176 from baseline (Day 1, prior to dosing) in mean ACQ scores in participants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.
Time Frame Day 176
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had ACQ data available on Day 176.
Arm/Group Title Placebo MEDI528 30 mg MEDI528 100 mg MEDI528 300 mg
Hide Arm/Group Description:
Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Overall Number of Participants Analyzed 82 81 83 81
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.27  (1.17) -1.32  (1.23) -1.46  (1.07) -1.45  (1.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.813
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.290
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.303
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
9.Secondary Outcome
Title Proportion of Participants Achieving Mean Asthma Control Questionnaire (ACQ) Scores at Day 92 of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 (Intent-to-Treat Analysis)
Hide Description Proportion of participants achieving mean ACQ scores of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 at Day 92 in participants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.
Time Frame Day 92
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had ACQ data available on Day 92.
Arm/Group Title Placebo MEDI528 30 mg MEDI528 100 mg MEDI528 300 mg
Hide Arm/Group Description:
Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Overall Number of Participants Analyzed 82 81 83 81
Measure Type: Number
Unit of Measure: Participants
< or = 0.75 17 17 17 22
> 0.75 and < 1.5 23 21 22 16
> or = 1.5 42 43 44 43
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 30 mg, MEDI528 100 mg, MEDI528 300 mg
Comments Combined MEDI-528 treatment was compared to placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.764
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
10.Secondary Outcome
Title Proportion of Participants Achieving Mean Asthma Control Questionnaire (ACQ) Scores at Day 176 of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 (Intent-to-Treat Analysis)
Hide Description Proportion of participants achieving mean ACQ scores of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 at Day 176 in participants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.
Time Frame Day 176
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had ACQ data available on Day 176.
Arm/Group Title Placebo MEDI528 30 mg MEDI528 100 mg MEDI528 300 mg
Hide Arm/Group Description:
Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Overall Number of Participants Analyzed 82 81 83 81
Measure Type: Number
Unit of Measure: Participants
< or = 0.75 25 29 24 25
> 0.75 and < 1.5 19 18 18 20
> or = 1.5 38 34 41 36
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 30 mg, MEDI528 100 mg, MEDI528 300 mg
Comments Combined MEDI-528 treatment was compared to placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.986
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
11.Secondary Outcome
Title Time to First Observed Mean Asthma Control Questionnaire (ACQ) Change From Baseline > or = 0.5 Through Day 92 (Intent-to-Treat Analysis)
Hide Description Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the time to first observed mean ACQ change from baseline (Day 1, prior to dosing) > or = 0.5 through Day 92 (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.
Time Frame Days 1 - 92
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had ACQ data through Day 92.
Arm/Group Title Placebo MEDI528 30 mg MEDI528 100 mg MEDI528 300 mg
Hide Arm/Group Description:
Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Overall Number of Participants Analyzed 82 81 83 81
Median (95% Confidence Interval)
Unit of Measure: Day
15.0
(15.0 to 22.0)
17.0
(15.0 to 21.0)
20.0
(15.0 to 23.0)
20.0
(15.0 to 27.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7171
Comments [Not Specified]
Method Log Rank
Comments Stratified by atopic asthma status and steroid use
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.955
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6219
Comments [Not Specified]
Method Log Rank
Comments Stratified by atopic asthma status and steroid use
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.942
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6182
Comments [Not Specified]
Method Log Rank
Comments Stratified by atopic asthma status and steroid use
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.909
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Time to First Observed Mean Asthma Control Questionnaire (ACQ) Change From Baseline > or = 0.5 Through Day 176 (Intent-to-Treat Analysis)
Hide Description Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the time to first observed mean ACQ change from baseline (Day 1, prior to dosing) > or = 1.5 Through Day 176 (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.
Time Frame Days 1 - 176
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had ACQ data through Day 176.
Arm/Group Title Placebo MEDI528 30 mg MEDI528 100 mg MEDI528 300 mg
Hide Arm/Group Description:
Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Overall Number of Participants Analyzed 82 81 83 81
Median (95% Confidence Interval)
Unit of Measure: Day
15.0
(15.0 to 22.0)
17.0
(15.0 to 21.0)
20.0
(15.0 to 23.0)
20.0
(15.0 to 27.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7120
Comments [Not Specified]
Method Log Rank
Comments Stratified by atopic asthma status and steroid use
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.952
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5086
Comments [Not Specified]
Method Log Rank
Comments Stratified by atopic asthma status and steroid use
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.928
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5184
Comments [Not Specified]
Method Log Rank
Comments Stratified by atopic asthma status and steroid use
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.887
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change at Day 92 From Baseline in Forced Expiratory Volume in One Second (FEV1) (Intent-to-Treat Analysis)
Hide Description Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the mean change at Day 92 from baseline (Day 1, prior to dosing) in FEV1.
Time Frame Day 92
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants randomized into the 30, 100, or 300 mg MEDI-528 (n=81, 83, or 81, respectively) or placebo (n=82) groups who had FEV1 data available at Day 92 (n=62, 73, or 72 for 30, 100, or 300 mg MEDI-528, respectively, and n=67 for placebo).
Arm/Group Title Placebo MEDI528 30 mg MEDI528 100 mg MEDI528 300 mg
Hide Arm/Group Description:
Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Overall Number of Participants Analyzed 67 62 73 72
Mean (Standard Deviation)
Unit of Measure: Liters
0.033  (0.326) 0.045  (0.327) 0.048  (0.230) 0.097  (0.290)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.837
Comments [Not Specified]
Method Two-sample t-test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.756
Comments [Not Specified]
Method Two-sample t-test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.224
Comments [Not Specified]
Method Two-sample t-test
Comments [Not Specified]
14.Secondary Outcome
Title Change at Day 176 From Baseline in Forced Expiratory Volume in One Second (FEV1) (Intent-to-Treat Analysis)
Hide Description Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the mean change from baseline (Day 1, prior to dosing) in FEV1 at Day 176
Time Frame Day 176
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants randomized into the 30, 100, or 300 mg MEDI-528 (n=81, 83, or 81, respectively) or placebo (n=82) groups who had FEV1 data available at Day 176 (n=67, 75, or 73 for 30, 100, or 300 mg MEDI-528, respectively, and n=69 for placebo).
Arm/Group Title Placebo MEDI528 30 mg MEDI528 100 mg MEDI528 300 mg
Hide Arm/Group Description:
Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Overall Number of Participants Analyzed 69 67 75 73
Mean (Standard Deviation)
Unit of Measure: Liters
0.044  (0.367) -0.005  (0.324) 0.055  (0.299) 0.047  (0.290)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.409
Comments [Not Specified]
Method Two-sample t-test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.847
Comments [Not Specified]
Method Two-sample t-test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.968
Comments [Not Specified]
Method Two-sample t-test
Comments [Not Specified]
15.Secondary Outcome
Title Proportion of Participants Who Had a Asthma Quality of Life Questionnaire - Standard (AQLQ[S]) Assessment Response at Day 85 (Intent-to-Treat Analysis)
Hide Description Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the proportion of participants who had an AQLQ(S) assessment response (defined as an improvement of at least 0.5 score in AQLQ[S]) at Day 85 (Intent-to-Treat Analysis). The AQLQ(S) is a 32-item questionnaire that measures the health related quality of life experienced by asthma patients. In the study, participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean response to all questions. Individual improvement in the overall score of 0.5 has been identified as the minimally important difference, with score changes > 1.5 identified to be large meaningful differences.
Time Frame Day 85
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had AQLQ(S) data at Day 85 (n=69, 63, 76, and 68 for placebo, 30, 100, and 300 mg MEDI-528, respectively).
Arm/Group Title Placebo MEDI528 30 mg MEDI528 100 mg MEDI528 300 mg
Hide Arm/Group Description:
Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Overall Number of Participants Analyzed 69 63 76 68
Measure Type: Number
Unit of Measure: Participants
53 43 52 49
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 30 mg, MEDI528 100 mg, MEDI528 300 mg
Comments Combined MEDI-528 dose groups versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.208
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
16.Secondary Outcome
Title Proportion of Participants Who Had a Asthma Quality of Life Questionnaire - Standard (AQLQ[S]) Assessment Response at Day 176 (Intent-to-Treat Analysis)
Hide Description Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the proportion of participants who had an AQLQ(S) assessment response at Day 176 (Intent-to-Treat Analysis). The AQLQ(S) is a 32-item questionnaire that measures the health related quality of life experienced by asthma patients. In the study, participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean response to all questions. Individual improvement in the overall score of 0.5 has been identified as the minimally important difference, with score changes > 1.5 identified to be large meaningful differences.
Time Frame Day 176
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had AQLQ(S) data at Day 176 (n=62, 58, 64, and 60 for placebo, 30, 100, and 300 mg MEDI-528, respectively).
Arm/Group Title Placebo MEDI528 30 mg MEDI528 100 mg MEDI528 300 mg
Hide Arm/Group Description:
Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Overall Number of Participants Analyzed 62 58 64 60
Measure Type: Number
Unit of Measure: Participants
50 42 48 46
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI528 30 mg, MEDI528 100 mg, MEDI528 300 mg
Comments Combined MEDI-528 dose groups versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.574
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
17.Secondary Outcome
Title Proportion of Participants With Detectable Anti-drug Antibodies to MEDI-528
Hide Description Proportion of participants with detectable anti-drug antibodies to MEDI-528 in subjects receiving 30, 100, or 300 mg MEDI-528 and placebo
Time Frame Days 1, 29, 57, 85, 127, 169, 176, 204,260, and 323
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo (n=82) group and received at least one dose of investigational product.
Arm/Group Title Placebo MEDI528 30 mg MEDI528 100 mg MEDI528 300 mg
Hide Arm/Group Description:
Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Overall Number of Participants Analyzed 82 81 83 81
Measure Type: Number
Unit of Measure: Participants
4 15 4 3
18.Secondary Outcome
Title First Dose Trough Concentration of MEDI-528
Hide Description First dose trough concentration of MEDI-528 measured on Day 15 prior to administration of the second dose of MEDI-528 (30, 100, or 300 mg). Serum concentrations of MEDI-528 were measured on Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323. The first dose trough concentration of MEDI-528 was measured on Day 15 prior to the Day 15 dose.
Time Frame Day 15
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants randomized into the 30, 100, or 300 mg MEDI-528 group (n=81, 83, or 81, respectively).
Arm/Group Title Placebo MEDI528 30 mg MEDI528 100 mg MEDI528 300 mg
Hide Arm/Group Description:
Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Overall Number of Participants Analyzed 0 81 83 81
Mean (Standard Deviation)
Unit of Measure: Microgram per milliliter
2.15  (0.81) 5.91  (2.97) 15.80  (5.68)
19.Secondary Outcome
Title Day 169 Steady State Trough Concentration of MEDI-528
Hide Description Trough concentration of MEDI-528 measured on Day 169 prior to administration of the last dose of MEDI-528 (30, 100, or 300 mg). Serum concentrations of MEDI-528 were measured on Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323. Steady state trough concentration of MEDI-528 was measured on Day 169.
Time Frame Day 169
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants randomized into the 30, 100, or 300 mg MEDI-528 group (n=81, 83, or 81, respectively).
Arm/Group Title Placebo MEDI528 30 mg MEDI528 100 mg MEDI528 300 mg
Hide Arm/Group Description:
Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Overall Number of Participants Analyzed 0 81 83 81
Mean (Standard Deviation)
Unit of Measure: Microgram per milliliter
5.99  (3.37) 21.68  (9.49) 61.57  (26.85)
20.Secondary Outcome
Title Half Life of MEDI-528
Hide Description Half life of MEDI-528 in subjects receiving 30, 100, or 300 mg MEDI-528. Serum concentrations of MEDI-528 were measured on Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323.
Time Frame Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants randomized into the 30, 100, or 300 mg MEDI-528 group (n=81, 83, or 81, respectively).
Arm/Group Title Placebo MEDI528 30 mg MEDI528 100 mg MEDI528 300 mg
Hide Arm/Group Description:
Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Overall Number of Participants Analyzed 0 81 83 81
Mean (Standard Deviation)
Unit of Measure: Days
39.0  (8.14) 32.6  (5.89) 32.2  (6.41)
21.Secondary Outcome
Title Accumulation Ratio of Trough Concentrations of MEDI-528
Hide Description Accumulation ratio of trough concentrations of MEDI-528 in subjects receiving 30, 100, or 300 mg MEDI-528. Serum concentrations of MEDI-528 were measured on Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323.
Time Frame Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81) and received at least one dose of investigational product.
Arm/Group Title Placebo MEDI528 30 mg MEDI528 100 mg MEDI528 300 mg
Hide Arm/Group Description:
Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Overall Number of Participants Analyzed 0 81 83 81
Mean (Standard Deviation)
Unit of Measure: Ratio
3.46  (1.53) 4.18  (1.83) 4.11  (1.99)
Time Frame Day 1 to Day 323
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo MEDI528 30 mg MEDI528 100 mg MEDI528 300 mg
Hide Arm/Group Description Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
All-Cause Mortality
Placebo MEDI528 30 mg MEDI528 100 mg MEDI528 300 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo MEDI528 30 mg MEDI528 100 mg MEDI528 300 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/82 (4.88%)      9/81 (11.11%)      4/83 (4.82%)      2/81 (2.47%)    
Gastrointestinal disorders         
Pancreatitis  1  1/82 (1.22%)  1 0/81 (0.00%)  0 0/83 (0.00%)  0 0/81 (0.00%)  0
Hepatobiliary disorders         
Cholelithiasis  1  1/82 (1.22%)  1 0/81 (0.00%)  0 0/83 (0.00%)  0 0/81 (0.00%)  0
Hydrocholecystis  1  1/82 (1.22%)  1 0/81 (0.00%)  0 0/83 (0.00%)  0 0/81 (0.00%)  0
Immune system disorders         
Food allergy  1  0/82 (0.00%)  0 1/81 (1.23%)  1 0/83 (0.00%)  0 0/81 (0.00%)  0
Infections and infestations         
Appendicitis  1  1/82 (1.22%)  1 0/81 (0.00%)  0 0/83 (0.00%)  0 0/81 (0.00%)  0
Bronchitis  1  0/82 (0.00%)  0 1/81 (1.23%)  1 0/83 (0.00%)  0 0/81 (0.00%)  0
Lobar pneumonia  1  0/82 (0.00%)  0 0/81 (0.00%)  0 1/83 (1.20%)  1 0/81 (0.00%)  0
Pneumonia  1  0/82 (0.00%)  0 3/81 (3.70%)  3 0/83 (0.00%)  0 0/81 (0.00%)  0
Injury, poisoning and procedural complications         
Limb traumatic amputation  1  0/82 (0.00%)  0 1/81 (1.23%)  1 0/83 (0.00%)  0 0/81 (0.00%)  0
Thoracic vertebral fracture  1  0/82 (0.00%)  0 0/81 (0.00%)  0 1/83 (1.20%)  1 0/81 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Muscle spasms  1  0/82 (0.00%)  0 0/81 (0.00%)  0 1/83 (1.20%)  1 0/81 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Uterine leiomyoma  1  0/82 (0.00%)  0 0/81 (0.00%)  0 1/83 (1.20%)  1 0/81 (0.00%)  0
Nervous system disorders         
Complicated migraine  1  0/82 (0.00%)  0 1/81 (1.23%)  1 0/83 (0.00%)  0 0/81 (0.00%)  0
Ischaemic stroke  1  0/82 (0.00%)  0 1/81 (1.23%)  1 0/83 (0.00%)  0 0/81 (0.00%)  0
Renal and urinary disorders         
Nephrolithiasis  1  1/82 (1.22%)  1 0/81 (0.00%)  0 0/83 (0.00%)  0 0/81 (0.00%)  0
Reproductive system and breast disorders         
Vaginal haemorrhage  1  0/82 (0.00%)  0 0/81 (0.00%)  0 1/83 (1.20%)  1 0/81 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Asthma  1  0/82 (0.00%)  0 6/81 (7.41%)  6 1/83 (1.20%)  1 2/81 (2.47%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo MEDI528 30 mg MEDI528 100 mg MEDI528 300 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   67/82 (81.71%)      62/81 (76.54%)      68/83 (81.93%)      69/81 (85.19%)    
Gastrointestinal disorders         
Diarrhoea  1  2/82 (2.44%)  2 3/81 (3.70%)  3 3/83 (3.61%)  4 3/81 (3.70%)  3
Toothache  1  1/82 (1.22%)  1 2/81 (2.47%)  2 4/83 (4.82%)  4 0/81 (0.00%)  0
General disorders         
Asthenia  1  2/82 (2.44%)  3 3/81 (3.70%)  3 1/83 (1.20%)  1 1/81 (1.23%)  1
Injection site erythema  1  2/82 (2.44%)  3 1/81 (1.23%)  2 4/83 (4.82%)  10 5/81 (6.17%)  9
Injection site pain  1  5/82 (6.10%)  6 1/81 (1.23%)  1 4/83 (4.82%)  5 2/81 (2.47%)  14
Pyrexia  1  0/82 (0.00%)  0 0/81 (0.00%)  0 4/83 (4.82%)  4 3/81 (3.70%)  3
Infections and infestations         
Acute sinusitis  1  2/82 (2.44%)  2 3/81 (3.70%)  4 2/83 (2.41%)  2 2/81 (2.47%)  4
Bronchitis  1  8/82 (9.76%)  8 4/81 (4.94%)  5 2/83 (2.41%)  3 5/81 (6.17%)  7
Gastroenteritis  1  3/82 (3.66%)  3 2/81 (2.47%)  2 5/83 (6.02%)  5 2/81 (2.47%)  2
Influenza  1  6/82 (7.32%)  8 10/81 (12.35%)  11 5/83 (6.02%)  5 2/81 (2.47%)  2
Nasopharyngitis  1  12/82 (14.63%)  15 11/81 (13.58%)  15 5/83 (6.02%)  9 7/81 (8.64%)  11
Pharyngitis  1  2/82 (2.44%)  2 4/81 (4.94%)  4 8/83 (9.64%)  13 4/81 (4.94%)  5
Rhinitis  1  5/82 (6.10%)  5 3/81 (3.70%)  3 3/83 (3.61%)  3 2/81 (2.47%)  2
Sinusitis  1  4/82 (4.88%)  5 10/81 (12.35%)  11 4/83 (4.82%)  4 6/81 (7.41%)  10
Upper respiratory tract infection  1  12/82 (14.63%)  19 6/81 (7.41%)  6 16/83 (19.28%)  23 20/81 (24.69%)  32
Urinary tract infection  1  6/82 (7.32%)  6 7/81 (8.64%)  9 7/83 (8.43%)  7 2/81 (2.47%)  3
Viral upper respiratory tract infection  1  5/82 (6.10%)  7 1/81 (1.23%)  4 0/83 (0.00%)  0 3/81 (3.70%)  3
Musculoskeletal and connective tissue disorders         
Back pain  1  2/82 (2.44%)  2 3/81 (3.70%)  3 3/83 (3.61%)  3 2/81 (2.47%)  3
Pain in extremity  1  2/82 (2.44%)  2 1/81 (1.23%)  1 3/83 (3.61%)  3 3/81 (3.70%)  4
Nervous system disorders         
Dizziness  1  5/82 (6.10%)  5 2/81 (2.47%)  2 5/83 (6.02%)  15 0/81 (0.00%)  0
Headache  1  8/82 (9.76%)  11 13/81 (16.05%)  20 5/83 (6.02%)  9 6/81 (7.41%)  7
Migraine  1  1/82 (1.22%)  1 4/81 (4.94%)  5 1/83 (1.20%)  1 1/81 (1.23%)  1
Respiratory, thoracic and mediastinal disorders         
Asthma  1  25/82 (30.49%)  41 28/81 (34.57%)  53 20/83 (24.10%)  29 31/81 (38.27%)  64
Cough  1  0/82 (0.00%)  0 2/81 (2.47%)  2 2/83 (2.41%)  2 3/81 (3.70%)  3
Oropharyngeal pain  1  0/82 (0.00%)  0 2/81 (2.47%)  2 3/83 (3.61%)  3 2/81 (2.47%)  2
Rhinitis allergic  1  7/82 (8.54%)  7 5/81 (6.17%)  5 1/83 (1.20%)  1 3/81 (3.70%)  4
Skin and subcutaneous tissue disorders         
Pruritus  1  1/82 (1.22%)  1 1/81 (1.23%)  1 2/83 (2.41%)  3 3/81 (3.70%)  3
Rash  1  3/82 (3.66%)  4 2/81 (2.47%)  2 1/83 (1.20%)  2 4/81 (4.94%)  5
Vascular disorders         
Hypertension  1  2/82 (2.44%)  3 4/81 (4.94%)  4 3/83 (3.61%)  3 0/81 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.
Results Point of Contact
Name/Title: Joe Parker, MD
Organization: MedImmune
Phone: 301-398-0000
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00968669     History of Changes
Other Study ID Numbers: MI-CP198
First Submitted: August 28, 2009
First Posted: August 31, 2009
Results First Submitted: February 25, 2014
Results First Posted: June 4, 2014
Last Update Posted: June 4, 2014