Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00968669
First received: August 28, 2009
Last updated: May 6, 2014
Last verified: May 2014
Results First Received: February 25, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Biological: MEDI528 30 mg
Biological: MEDI528 100 mg
Biological: MEDI528 300 mg
Other: Placebo

  Participant Flow
  Hide Participant Flow

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

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Placebo Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI528 30 mg MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI528 100 mg MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI528 300 mg MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks

Participant Flow:   Overall Study
    Placebo     MEDI528 30 mg     MEDI528 100 mg     MEDI528 300 mg  
STARTED     82     81     83     81  
COMPLETED     64     63     72     72  
NOT COMPLETED     18     18     11     9  
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  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI528 30 mg MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI528 100 mg MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI528 300 mg MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Total Total of all reporting groups

Baseline Measures
    Placebo     MEDI528 30 mg     MEDI528 100 mg     MEDI528 300 mg     Total  
Number of Participants  
[units: participants]
  82     81     83     81     327  
Age  
[units: Years]
Mean ± Standard Deviation
  43.6  ± 11.6     41.8  ± 11.1     45.1  ± 11.6     41.5  ± 12.3     43.0  ± 11.7  
Gender  
[units: Participants]
         
Female     53     55     62     55     225  
Male     29     26     21     26     102  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change at Day 92 From Baseline in Mean Asthma Control Questionnaire (ACQ) Scores (Intent-toTreat Analysis)   [ Time Frame: Day 92 ]

2.  Secondary:   Weighted Asthma Exacerbation Rate Through Day 92 (Intent-to-Treat Analysis)   [ Time Frame: Days 1 - 92 ]

3.  Secondary:   Weighted Asthma Exacerbation Rate Through Day 176 (Intent-to-Treat Analysis)   [ Time Frame: Days 1 - 176 ]

4.  Secondary:   Proportion of Participants Experiencing at Least One Asthma Exacerbation Through Day 92 (Intent-to-Treat Analysis)   [ Time Frame: Days 1 - 92 ]

5.  Secondary:   Proportion of Participants Experiencing at Least One Asthma Exacerbation Through Day 176 (Intent-to-Treat Analysis)   [ Time Frame: Days 1 - 176 ]

6.  Secondary:   Time to First Asthma Exacerbation Through Day 92 (Intent-to-Treat Analysis)   [ Time Frame: Days 1 - 92 ]

7.  Secondary:   Time to First Asthma Exacerbation Through Day 176 (Intent-to-Treat Analysis)   [ Time Frame: Days 1 - 176 ]

8.  Secondary:   Change at Day 176 From Baseline in Mean Asthma Control Questionnaire Scores (Intent-to-Treat Analysis)   [ Time Frame: Day 176 ]

9.  Secondary:   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)   [ Time Frame: Day 92 ]

10.  Secondary:   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)   [ Time Frame: Day 176 ]

11.  Secondary:   Time to First Observed Mean Asthma Control Questionnaire (ACQ) Change From Baseline > or = 0.5 Through Day 92 (Intent-to-Treat Analysis)   [ Time Frame: Days 1 - 92 ]

12.  Secondary:   Time to First Observed Mean Asthma Control Questionnaire (ACQ) Change From Baseline > or = 0.5 Through Day 176 (Intent-to-Treat Analysis)   [ Time Frame: Days 1 - 176 ]

13.  Secondary:   Change at Day 92 From Baseline in Forced Expiratory Volume in One Second (FEV1) (Intent-to-Treat Analysis)   [ Time Frame: Day 92 ]

14.  Secondary:   Change at Day 176 From Baseline in Forced Expiratory Volume in One Second (FEV1) (Intent-to-Treat Analysis)   [ Time Frame: Day 176 ]

15.  Secondary:   Proportion of Participants Who Had a Asthma Quality of Life Questionnaire - Standard (AQLQ[S]) Assessment Response at Day 85 (Intent-to-Treat Analysis)   [ Time Frame: Day 85 ]

16.  Secondary:   Proportion of Participants Who Had a Asthma Quality of Life Questionnaire - Standard (AQLQ[S]) Assessment Response at Day 176 (Intent-to-Treat Analysis)   [ Time Frame: Day 176 ]

17.  Secondary:   Proportion of Participants With Detectable Anti-drug Antibodies to MEDI-528   [ Time Frame: Days 1, 29, 57, 85, 127, 169, 176, 204,260, and 323 ]

18.  Secondary:   First Dose Trough Concentration of MEDI-528   [ Time Frame: Day 15 ]

19.  Secondary:   Day 169 Steady State Trough Concentration of MEDI-528   [ Time Frame: Day 169 ]

20.  Secondary:   Half Life of MEDI-528   [ Time Frame: Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323 ]

21.  Secondary:   Accumulation Ratio of Trough Concentrations of MEDI-528   [ Time Frame: Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Joe Parker, MD
Organization: MedImmune
phone: 301-398-0000
e-mail: parkerJ@medimmune.com


No publications provided by MedImmune LLC

Publications automatically indexed to this study:

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00968669     History of Changes
Other Study ID Numbers: MI-CP198
Study First Received: August 28, 2009
Results First Received: February 25, 2014
Last Updated: May 6, 2014
Health Authority: United States: Food and Drug Administration