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Efficacy and Safety Study of Benralizumab Added to Medium-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma

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ClinicalTrials.gov Identifier: NCT01947946
Recruitment Status : Terminated (Study terminated due to sponsor decision)
First Posted : September 23, 2013
Results First Posted : November 23, 2015
Last Update Posted : November 24, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Asthma
Interventions Biological: Benralizumab
Biological: Placebo
Enrollment 13
Recruitment Details The study was stopped with 13 patients randomised
Pre-assignment Details  
Arm/Group Title Benra 30 mg q.4 Weeks Benra 30 Mg-Placebo q.8 Weeks Placebo
Hide Arm/Group Description Fixed 30 mg dose of benralizumab every 4 weeks. Fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administered at the 4 week interim treatment visits to maintain blind). A (Dummy) injection
Period Title: Overall Study
Started 3 5 5
Completed 0 [1] 0 0
Not Completed 3 5 5
[1]
Study Stopped
Arm/Group Title Benra 30 mg q.4 Weeks Benra 30 Mg-Placebo q.8 Weeks Placebo Total
Hide Arm/Group Description Fixed 30 mg dose of benralizumab every 4 weeks. Fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administered at the 4 week interim treatment visits to maintain blind). A (Dummy) injection Total of all reporting groups
Overall Number of Baseline Participants 3 5 5 13
Hide Baseline Analysis Population Description
The number of participants for analysis will be from the full analysis set. The full analysis set consists of all patients randomized and receiving any investigational product, irrespective of their protocol adherence and continued participation in the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 5 participants 5 participants 13 participants
58.7  (15.70) 57.8  (6.38) 49.6  (6.35) 54.8  (9.32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 5 participants 5 participants 13 participants
Female
2
  66.7%
4
  80.0%
5
 100.0%
11
  84.6%
Male
1
  33.3%
1
  20.0%
0
   0.0%
2
  15.4%
1.Primary Outcome
Title Asthma Exacerbations Over 48 Weeks Treatment
Hide Description The number of asthma exacerbations over 48 weeks treatment will be counted
Time Frame 48 weeks treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from the full analysis set will be used. All patients randomized and receiving any investigational product will be included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Arm/Group Title Benra 30 mg q.4 Weeks Benra 30 Mg-Placebo q.8 Weeks Placebo
Hide Arm/Group Description:
Fixed 30 mg dose of benralizumab every 4 weeks.
Fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administered at the 4 week interim treatment visits to maintain blind).
A (Dummy) injection
Overall Number of Participants Analyzed 3 3 3
Measure Type: Number
Unit of Measure: Number of events
0 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Benra 30 mg q.4 Weeks Benra 30 Mg-Placebo q.8 Weeks Placebo
Hide Arm/Group Description Fixed 30 mg dose of benralizumab every 4 weeks. Fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administered at the 4 week interim treatment visits to maintain blind). A (Dummy) injection
All-Cause Mortality
Benra 30 mg q.4 Weeks Benra 30 Mg-Placebo q.8 Weeks Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Benra 30 mg q.4 Weeks Benra 30 Mg-Placebo q.8 Weeks Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/5 (0.00%)      0/5 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Benra 30 mg q.4 Weeks Benra 30 Mg-Placebo q.8 Weeks Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/5 (0.00%)      1/5 (20.00%)    
Respiratory, thoracic and mediastinal disorders       
Prolonged expiration *  0/3 (0.00%)  0 0/5 (0.00%)  0 1/5 (20.00%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Steven Fox
Organization: AZ-PPD
Phone: 441480716682
EMail: steven.fox@ppdi.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01947946     History of Changes
Other Study ID Numbers: D3250C00016
First Submitted: September 11, 2013
First Posted: September 23, 2013
Results First Submitted: July 21, 2015
Results First Posted: November 23, 2015
Last Update Posted: November 24, 2015