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Dose Ranging Efficacy And Safety With Mepolizumab in Severe Asthma (DREAM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01000506
First received: October 22, 2009
Last updated: January 7, 2016
Last verified: January 2016
Results First Received: November 9, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Biological: Mepolizumab 750
Biological: Mepolizumab 250
Biological: Mepolizumab 75
Drug: Placebo saline

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants (par.) who met the eligibility criteria at screening, entered the two week Run-in phase and par. who met the randomization eligibility criteria at the end of the Run-in phase entered into the 52-week Double-blind treatment period followed by a 4-week Follow-up phase. The total duration of participation in the study was 58 Weeks.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 888 par. were enrolled, of these, 168 were screen failures and 720 entered the run-in phase. 99 participants were run-in failures and 621 completed the run-in phase and were randomized. Of these, 616 participants were randomized and received treatment and were included within the Intent-to-Treat (ITT) Population.

Reporting Groups
  Description
Placebo IV Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
Mepolizumab 75 mg IV Participants received mepolizumab 75 milligrams (mg) IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
Mepolizumab 250 mg IV Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
Mepolizumab 750 mg IV Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).

Participant Flow:   Overall Study
    Placebo IV     Mepolizumab 75 mg IV     Mepolizumab 250 mg IV     Mepolizumab 750 mg IV  
STARTED     155     153     152     156  
COMPLETED     127     129     131     133  
NOT COMPLETED     28     24     21     23  
Adverse Event                 6                 5                 8                 9  
Lack of Efficacy                 8                 6                 4                 4  
Protocol Violation                 1                 1                 0                 0  
Lost to Follow-up                 1                 1                 4                 0  
Physician Decision                 1                 3                 3                 3  
Withdrawal by Subject                 11                 8                 2                 7  



  Baseline Characteristics
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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 IV Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
Mepolizumab 75 mg IV Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
Mepolizumab 250 mg IV Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
Mepolizumab 750 mg IV Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
Total Total of all reporting groups

Baseline Measures
    Placebo IV     Mepolizumab 75 mg IV     Mepolizumab 250 mg IV     Mepolizumab 750 mg IV     Total  
Number of Participants  
[units: participants]
  155     153     152     156     616  
Age  
[units: Years]
Mean (Standard Deviation)
  46.4  (11.33)     50.2  (10.84)     49.4  (11.63)     48.6  (11.06)     48.6  (11.28)  
Gender  
[units: Participants]
         
Female     97     104     93     93     387  
Male     58     49     59     63     229  
Race/Ethnicity, Customized  
[units: Participants]
         
African American/African Heritage     6     5     8     5     24  
American Indian or Alaska Native     0     0     0     1     1  
Asian - Central/South Asian Heritage     1     2     0     2     5  
Asian - East Asian Heritage     7     6     7     6     26  
Asian - South East Asian Heritage     0     1     0     2     3  
Native Hawaiian or other Pacific Islander     1     0     0     0     1  
White - Arabic/North African Heritage     3     1     2     1     7  
White - White/Caucasian/European Heritage     137     138     133     139     547  
Mixed Race     0     0     2     0     2  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Clinically Significant Exacerbations of Asthma Per Year   [ Time Frame: From randomization (Week 0) to Week 52 or early withdrawal (EW) ]

2.  Secondary:   Time to First Clinically Significant Exacerbation Requiring Oral or Systemic Corticosteroid, Hospitalization and/ or ED Visit   [ Time Frame: From randomization (Week 0) to Week 52 or EW ]

3.  Secondary:   Number of Exacerbations Requiring Hospitalization (Including Intubation and Admittance to an Intensive Care Unit [ICU]) or ED Visit Per Year   [ Time Frame: From randomization (Week 0) to Week 52 or EW ]

4.  Secondary:   Time to First Exacerbation Requiring Hospitalization or ED Visit   [ Time Frame: From randomization (Week 0) to Week 52 or EW ]

5.  Secondary:   Number of All Recorded Exacerbations Per Year   [ Time Frame: From randomization (Week 0) to Week 52 or EW ]

6.  Secondary:   Time to First All Recorded Exacerbation   [ Time Frame: From randomization (Week 0) to Week 52 or EW ]

7.  Secondary:   Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period   [ Time Frame: From Baseline up to Week 52 or EW ]

8.  Secondary:   Mean Change From Baseline in Clinic Post-bronchodilator FEV1 Over the 52-week Treatment Period   [ Time Frame: From Baseline up to Week 52 or EW ]

9.  Secondary:   Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Over the 52-week Treatment Period   [ Time Frame: From Baseline up to Week 52 or EW ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications:
Pavord I, Korn S, Howarth P, Bleecker E, Buhl R, Keene O, Ortega H, Chanez P. Mepolizumab (anti-IL-5) reduces exacerbations in patients with refractory eosinophilic asthma. [Lancet]. 2012;380(August 18, 2012):

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01000506     History of Changes
Other Study ID Numbers: 112997
Study First Received: October 22, 2009
Results First Received: November 9, 2015
Last Updated: January 7, 2016
Health Authority: Chile: Institutional Review Board
Romania: National Drug Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Argentina: Ministry of Health - A.N.M.A.T
Australia: Medicines Australia
Russia: Russian Ministry of Health
Ukraine: State Pharmacological Center of Ministry of Health of Ukraine
Germany: Bundesinstitut für Arzneimittel und Medizinprodukte
France: Agence Française de Sécurité Sanitaire des Produits de Santé
United States: Institutional Review Board
Poland: Ministry of Health & Social Welfare
South Korea: Food and Drug Administration
United States: Food and Drug Administration