- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00968669
A Study to Evaluate the Effectiveness and Safety of MEDI-528 in Adults
A Phase 2b, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous MEDI-528 in Adults With Uncontrolled Asthma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Buenos Aires, Argentina, C1424BSF
- Research Site
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Ciudad de Buenos Aire, Argentina, 1425
- Research Site
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Caba
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Buenos Aire, Caba, Argentina, 1425
- Research Site
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Ciudad de Buenos Aires
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Ciudad Autonoma Bs As, Ciudad de Buenos Aires, Argentina, 1405
- Research Site
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Santa Fe
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Rosario, Santa Fe, Argentina, 2000
- Research Site
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Tucuman
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San Miguel de Tucuman, Tucuman, Argentina, T4000IAR
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Santo André, Brazil, 09060-870
- Research Site
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Sao Paulo, Brazil, 05403-000
- Research Site
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RS
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Porto Alegre, RS, Brazil, 90020-090
- Research Site
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Porto Alegre, RS, Brazil, 90610-000
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Santa Catarina
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Florianopolis, Santa Catarina, Brazil, 88040-970
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Quebec, Canada
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Alberta
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Calgary, Alberta, Canada, T2N 4Z6
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Edmonton, Alberta, Canada, T6G 2B7
- Research Site
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- Research Site
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Ontario
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Mississauga, Ontario, Canada, L5A 3V4
- Research Site
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Ottawa, Ontario, Canada, K1Y 4G2
- Research Site
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Quebec
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Montreal, Quebec, Canada, H2X 2P4
- Research Site
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Quebec City, Quebec, Canada, G1V 4M6
- Research Site
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Cundinamarca
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Bogota, Cundinamarca, Colombia
- Research Site
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Bogota DC, Cundinamarca, Colombia
- Research Site
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Bogotá D.C., Cundinamarca, Colombia
- Research Site
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San José
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San Francisco de Dos Rios, San José, Costa Rica
- Research Site
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Ciudad de Panama, Panama
- Research Site
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Lima, Peru
- Research Site
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Lima, Peru, LIMA 27
- Research Site
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Lima, Peru, LIMA 33
- Research Site
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Lima
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Jesus Maria, Lima, Peru, Lima 11
- Research Site
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Batangas
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Lipa City, Batangas, Philippines
- Research Site
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Iloilo
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Iloilo City, Iloilo, Philippines, 5000
- Research Site
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Metro Manila
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Quezon City, Metro Manila, Philippines, 870
- Research Site
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Kaohsiung, Taiwan
- Research Site
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Taoyuan, Taiwan
- Research Site
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Alabama
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Pell City, Alabama, United States, 35128
- Research Site
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California
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Los Angeles, California, United States, 90025
- Research Site
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Sacramento, California, United States, 95819
- Research Site
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San Diego, California, United States, 92123
- Research Site
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Colorado
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Centennial, Colorado, United States, 80112
- Research Site
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Colarado Springs, Colorado, United States, 80907
- Research Site
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Thornton, Colorado, United States, 80233
- Research Site
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Connecticut
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Waterbury, Connecticut, United States, 06708
- Research Site
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Florida
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Kissimmee, Florida, United States, 34741
- Research Site
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Illinois
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Normal, Illinois, United States, 61761
- Research Site
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Kansas
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Overland Park, Kansas, United States, 66210
- Research Site
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Kentucky
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Louisville, Kentucky, United States, 40215
- Research Site
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Maryland
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Baltimore, Maryland, United States, 21236
- Research Site
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Silver Spring, Maryland, United States, 20902
- Research Site
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Massachusetts
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N. Dartmouth, Massachusetts, United States, 02747
- Research Site
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Minnesota
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Minneapolis, Minnesota, United States, 55402
- Research Site
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Nebraska
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Omaha, Nebraska, United States, 68131
- Research Site
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New Jersey
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Mt. Laurel, New Jersey, United States, 08054
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Ohio
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Sylvania, Ohio, United States, 43560
- Research Site
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Oregon
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Medford, Oregon, United States, 97504
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Rhode Island
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Lincoln, Rhode Island, United States, 02865
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South Carolina
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Greenville, South Carolina, United States, 29607
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Texas
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El Paso, Texas, United States, 79903
- Research Site
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San Antonio, Texas, United States, 78229
- Research Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Subjects must meet all of the following criteria:
- Male or female
- Age 18 through 65 years at the time of screening
- Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
Female subjects of childbearing potential who are sexually active with non-sterilized male partner must use adequate contraception from screening through the end of the study. An acceptable method of contraception is defined as one that has no higher than a 1% failure rate. Sustained abstinence is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception
- Non-sterilized males who are sexually active with a female of child-bearing potential must use adequate contraception from screening through the end of the study
- Females or female partners not of childbearing potential must have been surgically sterilized (eg, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or postmenopausal (defined as at least 1 year since last regular menses)
- Sterilized males must be at least 1-year post vasectomy and have obtained documentation of the absence of sperm in the ejaculate
- Weight ≥ 45 kg but ≤ 120 kg and body mass index (BMI) between 18 and 35 kg/m2
- Physician-diagnosed asthma by medical chart
- Currently taking inhaled corticosteroids (ICS) or is a candidate to receive ICS per Expert Panel Report (EPR)-3
- Pre-bronchodilator forced expiratory volume in 1 second (FEV1) value ≥ 40% at Day -28 and Day 1
A post-bronchodilator increase in FEV1 and/or FVC ≥ 12% and ≥ 200 mL at Day -28 OR meeting any one of the following criteria:
- Proof of post-bronchodilator reversibility of airflow obstruction ≥ 12% documented within 36 months prior to randomization or proof of a positive response to a methacholine challenge documented within 36 months prior to randomization; OR
- Proof of partial reversibility of ≥ 8% to < 12% improvement in post-bronchodilator FEV1 on Day -28 and achievement of ≥ 12% reversibility at a second time between Day -27 and Day -15; OR
- If a) and b) are not met and all other inclusion/exclusion criteria are met, subjects with a FEV1 of ≥ 1.5 L and ≥ 60% on Day -14 will be eligible to undergo a methacholine challenge. If the subject achieves a positive response to this methacholine challenge, then this criterion is met
Uncontrolled asthma consistent with EPR-3. In the 28 days before screening, subjects should have a history of one or more of the following:
- Daytime asthma symptoms ≥ 2 days/week
- Nighttime awakening ≥ 1 night/week
- Albuterol/salbutamol use ≥ 2 days/week
- An Asthma Control Questionnaire (ACQ) score ≥ 1.5 at Day -28 and at Day 1.
- At least one asthma exacerbation in the 12 months before screening that required intake of systemic corticosteroids after an unscheduled medical encounter or as agreed with a physician based on an asthma action plan that defines when oral steroids can be taken by the subject
- Ability and willingness to complete the follow-up period through Day 323 as required by the protocol.
Exclusion Criteria
Any of the following would exclude the subject from participation in the study:
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
- Concurrent enrollment in another clinical study
- Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals
- Known history of allergy or reaction to any component of the investigational product formulation
- History of anaphylaxis to other biologic therapy
- Lung disease other than asthma (eg, chronic obstructive pulmonary disease [COPD], cystic fibrosis)
- Severe depression as measured by a depression score > 15 on the Hospital Anxiety and Depression Scale (HADS) at either Day-28 or Day 1.
- History of suicidal behavior in the previous 3 years as measured by the Columbia Suicide Severity Rating Scale (C-SSRS) at Day -28.
- Acute illness other than asthma at the screening and randomization visits
- History of an active infection within 28 days before and during the screening period, or evidence of clinically significant active infection, including ongoing chronic infection
- History of ingestion of untreated water in a location known to be infected with parasites, resulting in acute or chronic diarrhea; history of recent travel to areas where parasite infestations are endemic within 6 months before screening; or a diagnosis of parasitic infection within 6 months before screening
- Use of immunosuppressive medication (except oral prednisone up to a dose of 20 mg every other day or equivalent [eg, 10 mg a day or 5 mg twice a day] and inhaled and topical corticosteroids) within 28 days before randomization
- Receipt of immunoglobulin or blood products within 28 days before randomization
- Plans to donate blood during the entire study period
- Donated blood or has had a blood transfusion within 28 days before screening
- Receipt of any non-biological study drugs or interventional therapy (including surgical procedures) within 28 days of the first dose of investigational product in this study
- Receipt of any biologicals including MEDI-528 within 5 half-lives before the first dose of investigational product in this study
- History of any known immunodeficiency disorder
- A positive hepatitis B surface antigen, or hepatitis C virus antibody, as determined by medical history and/or subject's verbal report
- A positive human immunodeficiency virus test or is taking antiretroviral medications, as determined by medical history and/or subject's verbal report
- A live attenuated vaccination received within 28 days before screening
- History of clinically significant abnormality on electrocardiogram (ECG) in the opinion of the investigator
- Breastfeeding or lactating
- History of treatment for alcohol or drug abuse within the past year
- History suggestive of COPD or of tobacco smoking ≥ 10 pack-years
- Evidence of any uncontrolled systemic disease upon physical examination
- History of cancer, apart from basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy ≥ 1 year before Day 1 or other malignancies treated with apparent success with curative therapy ≥ 5 years before screening
- Any noninfectious disease involving multiple organs (eg, cystic fibrosis, systemic lupus erythematosus, hemophilia, multiple sclerosis, etc.) that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
- Individuals who are legally institutionalized
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: MEDI528 30 mg
MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
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MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
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Experimental: MEDI528 100 mg
MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
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MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
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Experimental: MEDI528 300 mg
MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
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MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
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Experimental: Placebo
Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
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Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change at Day 92 From Baseline in Mean Asthma Control Questionnaire (ACQ) Scores (Intent-toTreat Analysis)
Time Frame: Day 92
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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.
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Day 92
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Weighted Asthma Exacerbation Rate Through Day 92 (Intent-to-Treat Analysis)
Time Frame: Days 1 - 92
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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.
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Days 1 - 92
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Weighted Asthma Exacerbation Rate Through Day 176 (Intent-to-Treat Analysis)
Time Frame: Days 1 - 176
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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.
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Days 1 - 176
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Proportion of Participants Experiencing at Least One Asthma Exacerbation Through Day 92 (Intent-to-Treat Analysis)
Time Frame: Days 1 - 92
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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.
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Days 1 - 92
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Proportion of Participants Experiencing at Least One Asthma Exacerbation Through Day 176 (Intent-to-Treat Analysis)
Time Frame: Days 1 - 176
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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.
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Days 1 - 176
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Time to First Asthma Exacerbation Through Day 92 (Intent-to-Treat Analysis)
Time Frame: Days 1 - 92
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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.
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Days 1 - 92
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Time to First Asthma Exacerbation Through Day 176 (Intent-to-Treat Analysis)
Time Frame: Days 1 - 176
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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.
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Days 1 - 176
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Change at Day 176 From Baseline in Mean Asthma Control Questionnaire Scores (Intent-to-Treat Analysis)
Time Frame: Day 176
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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.
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Day 176
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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
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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.
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Day 92
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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
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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.
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Day 176
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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
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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.
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Days 1 - 92
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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
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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.
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Days 1 - 176
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Change at Day 92 From Baseline in Forced Expiratory Volume in One Second (FEV1) (Intent-to-Treat Analysis)
Time Frame: Day 92
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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.
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Day 92
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Change at Day 176 From Baseline in Forced Expiratory Volume in One Second (FEV1) (Intent-to-Treat Analysis)
Time Frame: Day 176
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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
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Day 176
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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
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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.
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Day 85
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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
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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.
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Day 176
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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
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Proportion of participants with detectable anti-drug antibodies to MEDI-528 in subjects receiving 30, 100, or 300 mg MEDI-528 and placebo
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Days 1, 29, 57, 85, 127, 169, 176, 204,260, and 323
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First Dose Trough Concentration of MEDI-528
Time Frame: Day 15
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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.
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Day 15
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Day 169 Steady State Trough Concentration of MEDI-528
Time Frame: Day 169
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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.
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Day 169
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Half Life of MEDI-528
Time Frame: Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323
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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.
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Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323
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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
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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.
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Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Chad Oh, M.D., MedImmune LLC
Publications and helpful links
General Publications
- Lloyd CM, Hessel EM. Functions of T cells in asthma: more than just T(H)2 cells. Nat Rev Immunol. 2010 Dec;10(12):838-48. doi: 10.1038/nri2870. Epub 2010 Nov 9.
- Oh CK, Leigh R, McLaurin KK, Kim K, Hultquist M, Molfino NA. A randomized, controlled trial to evaluate the effect of an anti-interleukin-9 monoclonal antibody in adults with uncontrolled asthma. Respir Res. 2013 Sep 19;14(1):93. doi: 10.1186/1465-9921-14-93.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MI-CP198
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Asthma
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Vanderbilt University Medical CenterNot yet recruitingAsthma in Children | Asthma Attack | Asthma Acute | Acute Asthma Exacerbation | Asthma; StatusUnited States
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University of California, San FranciscoCompletedAsthma in Children | Asthma Attack | Asthma Acute | Asthma ChronicUnited States
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SingHealth PolyclinicsNot yet recruitingAsthma | Asthma in Children | Asthma Attack | Asthma Acute | Asthma Chronic
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Johann Wolfgang Goethe University HospitalCompleted
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Universita di VeronaCompleted
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Parc de Salut MarActive, not recruitingAsthma in Children | Persistent Asthma | Asthma ExacerbationSpain
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Forest LaboratoriesCompleted
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Brunel UniversityKarolinska InstitutetUnknown
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Johann Wolfgang Goethe University HospitalCompletedExercise-induced AsthmaGermany
Clinical Trials on MEDI528 30 mg
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MedImmune LLCCompleted
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MedImmune LLCTerminatedAsthmaUnited States, Canada
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MedImmune LLCTerminated
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Donesta BioscienceCompleted
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Fondazione OncotechNot yet recruiting
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Regeneron PharmaceuticalsCompletedRespiratory Syncytial Virus InfectionsUnited States, Australia, Bulgaria, Canada, Chile, Denmark, Finland, Germany, Hungary, Netherlands, New Zealand, Panama, Puerto Rico, South Africa, Spain, Sweden, Turkey, Ukraine, United Kingdom
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Cerevel Therapeutics, LLCCompleted
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Otsuka Pharmaceutical Development & Commercialization...Bill and Melinda Gates FoundationCompletedPulmonary TBSouth Africa
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Galderma R&DCompletedPrurigo NodularisUnited States, Germany, Austria, Canada, Denmark, Hungary, Italy, Poland, Sweden, United Kingdom
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PfizerCompletedHepatic Impairment | Healthy ParticipantsUnited States