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A Study to Evaluate the Effectiveness of MEDI-563 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

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ClinicalTrials.gov Identifier: NCT01227278
Recruitment Status : Completed
First Posted : October 25, 2010
Results First Posted : October 5, 2016
Last Update Posted : October 5, 2016
Sponsor:
Collaborator:
AstraZeneca
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 Pulmonary Disease, Chronic Obstructive
Interventions Other: Placebo
Biological: Benralizumab 100 mg
Enrollment 421
Recruitment Details A total of 421 participants were screened and 101 participants were randomized into the study.
Pre-assignment Details  
Arm/Group Title Placebo Benralizumab 100 mg
Hide Arm/Group Description Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337). Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
Period Title: Overall Study
Started 50 51
Completed 45 43
Not Completed 5 8
Reason Not Completed
Withdrawal by Subject             4             4
Death             0             2
Other             1             2
Arm/Group Title Placebo Benralizumab 100 mg Total
Hide Arm/Group Description Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337). Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337). Total of all reporting groups
Overall Number of Baseline Participants 50 51 101
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population included all participants randomized into the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 51 participants 101 participants
64.6  (7.5) 62.9  (8.2) 63.7  (7.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 51 participants 101 participants
Female
21
  42.0%
16
  31.4%
37
  36.6%
Male
29
  58.0%
35
  68.6%
64
  63.4%
1.Primary Outcome
Title Annualized Incidence Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Hide Description An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. Annualized Incidence Rate of Moderate or Severe AECOPD was assessed based on AECOPD data up to Day 393 (Rate = total number of moderate or severe AECOPD in each group/total person-year follow-up in each group). The severity of an exacerbation of COPD is defined as: a) Mild exacerbations, which require treatment with an increase in usual therapy, example (eg), increase use of short acting bronchodilators, b) Moderate exacerbations which require treatment with systemic corticosteroids, and or antibiotics and c) Severe exacerbations which require hospitalization.
Time Frame Day 1 up to 393
Hide Outcome Measure Data
Hide Analysis Population Description
The per protocol (PP) population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393.
Arm/Group Title Placebo Benralizumab 100 mg
Hide Arm/Group Description:
Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
Overall Number of Participants Analyzed 42 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: AECOPD events/person-year
0.92
(0.67 to 1.25)
0.95
(0.68 to 1.29)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Benralizumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.941
Comments [Not Specified]
Method Van Elteren Test
Comments Day 1 to 393: Van Elteren test was used to compare the two arms.
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.67 to 1.58
Estimation Comments 95 percent (%) confidence interval (CI) for rate ratio was based on normal approximation assuming rate with Poisson distribution.
2.Secondary Outcome
Title Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Hide Description An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Day 561 that were absent before treatment or that worsened relative to pre-treatment state. TEAEs reported below included both SAEs and non-serious AEs.
Time Frame Day 1 up to 561
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who received at least one dose of investigational drug.
Arm/Group Title Placebo Benralizumab 100 mg
Hide Arm/Group Description:
Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
Overall Number of Participants Analyzed 50 51
Measure Type: Number
Unit of Measure: participants
TEAEs 41 45
TESAEs 9 14
3.Secondary Outcome
Title Number of Participants Hospitalized Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Hide Description An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days.
Time Frame Day 1 up to 393
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393.
Arm/Group Title Placebo Benralizumab 100 mg
Hide Arm/Group Description:
Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
Overall Number of Participants Analyzed 42 40
Measure Type: Number
Unit of Measure: participants
5 2
4.Secondary Outcome
Title Percentage of Participants Hospitalized Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Hide Description An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days.
Time Frame Day 1 up to 393
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393.
Arm/Group Title Placebo Benralizumab 100 mg
Hide Arm/Group Description:
Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
Overall Number of Participants Analyzed 42 40
Measure Type: Number
Unit of Measure: percentage of participants
11.9 5.0
5.Secondary Outcome
Title Annual Incidence Rate of Hospitalization Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Hide Description An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. Annualized Incidence Rate of hospitalization due to AECOPD was calculated as Rate = total number of hospitalizations/ total person years.
Time Frame Day 1 up to 393
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393.
Arm/Group Title Placebo Benralizumab 100 mg
Hide Arm/Group Description:
Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
Overall Number of Participants Analyzed 42 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: hospitalizations/person-year
0.11
(0.05 to 0.26)
0.05
(0.01 to 0.18)
6.Secondary Outcome
Title Change From Baseline in COPD-Specific Saint George’s Respiratory Questionnaire (SGRQ-C) Total and Domain Scores at Day 393
Hide Description The SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question’s response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100. The total score and domain score are derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status.
Time Frame Baseline, Day 393
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
Arm/Group Title Placebo Benralizumab 100 mg
Hide Arm/Group Description:
Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
Overall Number of Participants Analyzed 42 40
Mean (Standard Deviation)
Unit of Measure: units on scale
Baseline: Total Score (n=42, 40) 48.04  (19.14) 51.75  (20.45)
Change at Day 393: Total Score (n=42, 37) -4.43  (11.71) -5.51  (16.64)
Baseline: Symptoms (n=42, 40) 64.59  (24.38) 67.18  (21.47)
Change at Day 393: Symptoms (n=42, 37) -3.19  (17.44) -9.02  (21.27)
Baseline: Activity (n=42, 40) 58.85  (23.22) 61.45  (25.53)
Change at Day 393: Activity (n=42, 37) -5.65  (14.85) -4.37  (24.89)
Baseline: Impact (n=42, 40) 35.94  (18.95) 40.69  (22.49)
Change at Day 393: Impact (n=42, 37) -4.16  (14.62) -4.95  (16.97)
7.Secondary Outcome
Title Percentage of Participants With Improvement in COPD-Specific Saint George’s Respiratory Questionnaire (SGRQ-C) Total Score
Hide Description SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question’s response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100. The total score and domain score were derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status. Percentage of participants with 4-point, 8-point and 12-point change from baseline in SGRQ-C total score were observed.
Time Frame Day 393
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
Arm/Group Title Placebo Benralizumab 100 mg
Hide Arm/Group Description:
Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
Overall Number of Participants Analyzed 42 40
Measure Type: Number
Unit of Measure: percentage of participants
Day 393, Total: 4-point change (n=42, 37) 59.5 54.1
Day 393: 8-point change (n=42, 37) 38.1 40.5
Day 393, Total: 12-point change (n=42, 37) 21.4 24.3
8.Secondary Outcome
Title Change From Baseline in Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS) Domain Scores at Day 393
Hide Description The CRQ-SAS is a self-administered questionnaire which consist of 20 items across four domains: dyspnea (5 items), fatigue (4 items), emotional function (7 items), and mastery (4 items). Participants rated their experience on a 7-point scale in response to each item ranging from 1 (maximum impairment) to 7 (no impairment). Individual items were equally weighted, and domain scores were calculated as the mean of all items within each domain; domain score range: 1 (maximum impairment) to 7 (no impairment).
Time Frame Baseline, Day 393
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
Arm/Group Title Placebo Benralizumab 100 mg
Hide Arm/Group Description:
Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
Overall Number of Participants Analyzed 42 40
Mean (Standard Deviation)
Unit of Measure: units on scale
Baseline: Dyspnea (n=42, 40) 4.97  (1.45) 4.74  (1.32)
Change at Day 393: Dyspnea (n=42, 37) -0.08  (1.29) 0.09  (1.00)
Baseline: Fatigue (n=42, 40) 4.38  (1.26) 3.96  (1.40)
Change at Day 393: Fatigue (n=42, 37) 0.11  (0.94) 0.11  (1.15)
Baseline: Emotional function (n=42, 40) 4.84  (1.24) 4.72  (1.17)
Change at Day 393: Emotional function (n=42, 37) 0.18  (0.98) 0.08  (1.18)
Baseline: Mastery (n=42, 40) 4.89  (1.50) 4.67  (1.40)
Change at Day 393: Mastery (n=42, 37) 0.24  (1.12) 0.28  (1.24)
9.Secondary Outcome
Title Percentage of Participants With a 0.5-Point Improvement in Chronic Respiratory Questionnaire Self-administered Standardized Format (CRQ-SAS) Domain Scores at Day 393
Hide Description The CRQ-SAS is a self-administered questionnaire which consist of 20 items across four domains: dyspnea (5 items), fatigue (4 items), emotional function (7 items), and mastery (4 items). Participants rated their experience on a 7-point scale in response to each item ranging from 1 (maximum impairment) to 7 (no impairment). Individual items were equally weighted, and domain scores were calculated as the mean of all items within each domain; domain score range: 1 (maximum impairment) to 7 (no impairment). Participants with 0.5 point improvement from baseline in the domain scores were observed.
Time Frame Day 393
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
Arm/Group Title Placebo Benralizumab 100 mg
Hide Arm/Group Description:
Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
Overall Number of Participants Analyzed 42 40
Measure Type: Number
Unit of Measure: percentage of participants
Day 393: Dyspnea (n=42, 37) 28.6 32.4
Day 393: Fatigue (n=42, 37) 35.7 35.1
Day 393: Emotional function (n=42, 37) 35.7 27.0
Day 393: Mastery (n=42, 37) 47.6 37.8
10.Secondary Outcome
Title Change From Baseline in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Scores at Day 393
Hide Description The BODE index is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the modified medical research council (MMRC) dyspnea scale and the 6-minute walk test. The MMRC dyspnea scale is a 5-point scale that measures the level of dyspnea (trouble breathing) experienced by participants where score range is 0 (none) to 4 (very severe ). BODE score is derived into a score range of 0 (healthy) to 10 (severe COPD).
Time Frame Baseline, Day 393
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
Arm/Group Title Placebo Benralizumab 100 mg
Hide Arm/Group Description:
Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
Overall Number of Participants Analyzed 42 40
Mean (Standard Deviation)
Unit of Measure: units on scale
Baseline (n=40, 39) 2.8  (2.0) 2.9  (1.8)
Change at Day 393 (n=37, 32) -0.1  (1.4) -0.5  (1.4)
Time Frame Day 1 to 561
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Benralizumab 100 mg
Hide Arm/Group Description Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337). Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
All-Cause Mortality
Placebo Benralizumab 100 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Benralizumab 100 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/50 (18.00%)      14/51 (27.45%)    
Cardiac disorders     
Cardiac failure congestive  1  0/50 (0.00%)  0 1/51 (1.96%)  1
Myocardial infarction  1  0/50 (0.00%)  0 1/51 (1.96%)  1
Gastrointestinal disorders     
Constipation  1  1/50 (2.00%)  1 0/51 (0.00%)  0
Small intestinal obstruction  1  0/50 (0.00%)  0 1/51 (1.96%)  1
General disorders     
Asthenia  1  0/50 (0.00%)  0 1/51 (1.96%)  1
Sudden death  1  0/50 (0.00%)  0 1/51 (1.96%)  1
Infections and infestations     
Bronchitis  1  1/50 (2.00%)  3 1/51 (1.96%)  1
Lobar pneumonia  1  0/50 (0.00%)  0 1/51 (1.96%)  1
Lower respiratory tract infection  1  1/50 (2.00%)  1 0/51 (0.00%)  0
Pharyngeal abscess  1  0/50 (0.00%)  0 1/51 (1.96%)  1
Pneumonia  1  0/50 (0.00%)  0 1/51 (1.96%)  1
Sepsis syndrome  1  0/50 (0.00%)  0 1/51 (1.96%)  1
Upper respiratory tract infection  1  0/50 (0.00%)  0 1/51 (1.96%)  1
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion  1  0/50 (0.00%)  0 1/51 (1.96%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Non-hodgkin's lymphoma  1  1/50 (2.00%)  1 0/51 (0.00%)  0
Squamous cell carcinoma of lung  1  0/50 (0.00%)  0 1/51 (1.96%)  1
Nervous system disorders     
Presyncope  1  1/50 (2.00%)  1 0/51 (0.00%)  0
Psychiatric disorders     
Alcohol withdrawal syndrome  1  1/50 (2.00%)  1 0/51 (0.00%)  0
Renal and urinary disorders     
Renal failure acute  1  0/50 (0.00%)  0 1/51 (1.96%)  1
Reproductive system and breast disorders     
Prostatitis  1  0/50 (0.00%)  0 1/51 (1.96%)  1
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  6/50 (12.00%)  8 6/51 (11.76%)  8
Vascular disorders     
Hypotension  1  0/50 (0.00%)  0 1/51 (1.96%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo Benralizumab 100 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   41/50 (82.00%)      44/51 (86.27%)    
Blood and lymphatic system disorders     
Anaemia  1  1/50 (2.00%)  1 1/51 (1.96%)  1
Cardiac disorders     
Angina pectoris  1  0/50 (0.00%)  0 2/51 (3.92%)  2
Gastrointestinal disorders     
Abdominal pain  1  1/50 (2.00%)  1 1/51 (1.96%)  1
Abdominal pain upper  1  4/50 (8.00%)  4 0/51 (0.00%)  0
Constipation  1  0/50 (0.00%)  0 2/51 (3.92%)  2
Diarrhoea  1  4/50 (8.00%)  4 0/51 (0.00%)  0
Gastrooesophageal reflux disease  1  3/50 (6.00%)  3 2/51 (3.92%)  2
Nausea  1  1/50 (2.00%)  1 1/51 (1.96%)  1
General disorders     
Asthenia  1  0/50 (0.00%)  0 2/51 (3.92%)  2
Injection site erythema  1  0/50 (0.00%)  0 3/51 (5.88%)  3
Injection site inflammation  1  0/50 (0.00%)  0 2/51 (3.92%)  2
Injection site pain  1  1/50 (2.00%)  1 1/51 (1.96%)  1
Injection site reaction  1  0/50 (0.00%)  0 3/51 (5.88%)  3
Oedema peripheral  1  1/50 (2.00%)  1 1/51 (1.96%)  1
Pyrexia  1  0/50 (0.00%)  0 3/51 (5.88%)  3
Infections and infestations     
Acute sinusitis  1  1/50 (2.00%)  1 1/51 (1.96%)  1
Bronchitis  1  3/50 (6.00%)  3 3/51 (5.88%)  3
Cystitis  1  2/50 (4.00%)  2 1/51 (1.96%)  1
Gastroenteritis  1  1/50 (2.00%)  1 2/51 (3.92%)  3
Gastroenteritis viral  1  0/50 (0.00%)  0 2/51 (3.92%)  2
Infective exacerbation of chronic obstructive airways disease  1  1/50 (2.00%)  3 1/51 (1.96%)  1
Nasopharyngitis  1  11/50 (22.00%)  13 5/51 (9.80%)  8
Oral candidiasis  1  2/50 (4.00%)  2 0/51 (0.00%)  0
Pharyngitis  1  1/50 (2.00%)  1 4/51 (7.84%)  4
Pneumonia  1  2/50 (4.00%)  2 2/51 (3.92%)  2
Rhinitis  1  1/50 (2.00%)  1 1/51 (1.96%)  2
Sinusitis  1  4/50 (8.00%)  4 3/51 (5.88%)  3
Upper respiratory tract infection  1  1/50 (2.00%)  1 5/51 (9.80%)  6
Urinary tract infection  1  1/50 (2.00%)  1 3/51 (5.88%)  3
Injury, poisoning and procedural complications     
Arthropod bite  1  2/50 (4.00%)  2 2/51 (3.92%)  2
Contusion  1  0/50 (0.00%)  0 3/51 (5.88%)  3
Fall  1  1/50 (2.00%)  1 3/51 (5.88%)  3
Post procedural complication  1  0/50 (0.00%)  0 2/51 (3.92%)  2
Investigations     
Breath sounds abnormal  1  2/50 (4.00%)  2 0/51 (0.00%)  0
C-reactive protein increased  1  1/50 (2.00%)  1 2/51 (3.92%)  2
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/50 (2.00%)  1 1/51 (1.96%)  1
Back pain  1  1/50 (2.00%)  1 3/51 (5.88%)  3
Intervertebral disc protrusion  1  2/50 (4.00%)  2 0/51 (0.00%)  0
Joint swelling  1  2/50 (4.00%)  2 1/51 (1.96%)  1
Muscle spasms  1  0/50 (0.00%)  0 3/51 (5.88%)  3
Musculoskeletal pain  1  3/50 (6.00%)  3 0/51 (0.00%)  0
Myalgia  1  2/50 (4.00%)  2 1/51 (1.96%)  1
Pain in extremity  1  0/50 (0.00%)  0 3/51 (5.88%)  3
Nervous system disorders     
Dizziness  1  1/50 (2.00%)  1 1/51 (1.96%)  1
Headache  1  3/50 (6.00%)  3 4/51 (7.84%)  7
Paraesthesia  1  1/50 (2.00%)  1 1/51 (1.96%)  1
Sciatica  1  0/50 (0.00%)  0 2/51 (3.92%)  2
Renal and urinary disorders     
Haematuria  1  0/50 (0.00%)  0 2/51 (3.92%)  3
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  25/50 (50.00%)  62 26/51 (50.98%)  53
Cough  1  4/50 (8.00%)  4 1/51 (1.96%)  1
Dyspnoea  1  5/50 (10.00%)  5 2/51 (3.92%)  2
Dyspnoea exertional  1  0/50 (0.00%)  0 2/51 (3.92%)  2
Epistaxis  1  1/50 (2.00%)  1 1/51 (1.96%)  1
Oropharyngeal pain  1  4/50 (8.00%)  4 0/51 (0.00%)  0
Rhinitis allergic  1  3/50 (6.00%)  3 0/51 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash  1  0/50 (0.00%)  0 2/51 (3.92%)  2
Vascular disorders     
Aortic arteriosclerosis  1  2/50 (4.00%)  2 0/51 (0.00%)  0
Hot flush  1  1/50 (2.00%)  1 2/51 (3.92%)  2
Hypertension  1  2/50 (4.00%)  2 1/51 (1.96%)  1
Hypotension  1  0/50 (0.00%)  0 2/51 (3.92%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
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
Layout table for Results Point of Contact information
Name/Title: Rene van der Merwe, MBChB/Senior Director, Clinical Development
Organization: MedImmune, LLC.
Phone: 301-398-0000
EMail: vandermerwer@medimmune.com
Layout table for additonal information
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01227278     History of Changes
Other Study ID Numbers: MI-CP196
2010-020127-52 ( EudraCT Number )
First Submitted: October 21, 2010
First Posted: October 25, 2010
Results First Submitted: August 11, 2016
Results First Posted: October 5, 2016
Last Update Posted: October 5, 2016