A Study of MEMP1972A in Patients With Allergic Asthma Inadequately Controlled on Inhaled Steroids And A Second Controller (COSTA)
NCT ID: NCT01582503
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
578 participants
INTERVENTIONAL
2012-04-30
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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MEMP1972A 150 mg
MEMP1972A
Subcutaneous repeating dose
MEMP1972A 300 mg
MEMP1972A
Subcutaneous repeating dose
MEMP1972A 450 mg
MEMP1972A
Subcutaneous repeating dose
Placebo
placebo
Subcutaneous repeating dose
Interventions
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MEMP1972A
Subcutaneous repeating dose
MEMP1972A
Subcutaneous repeating dose
MEMP1972A
Subcutaneous repeating dose
placebo
Subcutaneous repeating dose
Eligibility Criteria
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Inclusion Criteria
* Body weight \>/= 40 kg
* Physician's diagnosis of asthma for at least 12 months
* Evidence of documented bronchodilator reversibility as defined by protocol
* Prebronchodilator FEV1 \>/= 40% and \</= 80% predicted at Visit 1
* Required daily use of ICS and a second controller for a minimum of 3 consecutive months prior to Visit 1
* History of at least one protocol-defined asthma exacerbation in the 18 months prior to Visit 1
* Inadequately controlled asthma despite compliance with asthma controller therapy
Exclusion Criteria
* Pre-existing active lung disease other than asthma
* Any infection
* Clinically significant medical disease that is uncontrolled despite treatment or is likely to require a change in therapy during study or is of unknown etiology
* Known immunodeficiency, including but not limited to HIV infection, regardless of treatment status
* Current substance abuse
* Former smoker with \>10 pack-year history or current smoker; former smokers must have stopped smoking more than 12 months prior to Visit 1
* History of anaphylaxis
* Pregnant and lactating women
18 Years
75 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Birmingham, Alabama, United States
Bakersfield, California, United States
Costa Mesa, California, United States
Fountain Valley, California, United States
Long Beach, California, United States
Mission Viejo, California, United States
Rancho Cordova, California, United States
Redwood City, California, United States
Stockton, California, United States
Torrance, California, United States
Upland, California, United States
Centennial, Colorado, United States
Denver, Colorado, United States
New Haven, Connecticut, United States
Tampa, Florida, United States
Winter Park, Florida, United States
Albany, Georgia, United States
Twin Falls, Idaho, United States
Normal, Illinois, United States
River Forest, Illinois, United States
Iowa City, Iowa, United States
Overland Park, Kansas, United States
Louisville, Kentucky, United States
Baltimore, Maryland, United States
St Louis, Missouri, United States
Bellevue, Nebraska, United States
Omaha, Nebraska, United States
Edison, New Jersey, United States
Teaneck, New Jersey, United States
The Bronx, New York, United States
Winston-Salem, North Carolina, United States
Canton, Ohio, United States
Centerville, Ohio, United States
Cincinnati, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Medford, Oregon, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Providence, Rhode Island, United States
Warwick, Rhode Island, United States
Charleston, South Carolina, United States
El Paso, Texas, United States
El Paso, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Waco, Texas, United States
Murray, Utah, United States
Fairfax, Virginia, United States
Spokane, Washington, United States
Greenfield, Wisconsin, United States
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Mendoza, , Argentina
Quilmes, , Argentina
Rosario, , Argentina
Salta, , Argentina
San Juan Bautista, , Argentina
San Miguel de Tucumán, , Argentina
Gembloux, , Belgium
Halen, , Belgium
Leuven, , Belgium
Pleven, , Bulgaria
Plovdiv, , Bulgaria
Rousse, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Stara Zagora, , Bulgaria
Varna, , Bulgaria
Vancouver, British Columbia, Canada
Mississauga, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Berlin, , Germany
Berlin, , Germany
Bochum, , Germany
Coswig, , Germany
Freiburg im Breisgau, , Germany
Geesthacht, , Germany
Jena, , Germany
Landsberg, , Germany
Magdeburg, , Germany
Mainz, , Germany
Münster, , Germany
Balassagyarmat, , Hungary
Debrecen, , Hungary
Mosonmagyaróvar, , Hungary
Guadalajara, , Mexico
México, , Mexico
Nuevo León, , Mexico
Auckland, , New Zealand
Aucklund, , New Zealand
Christchurch, , New Zealand
Dunedin, , New Zealand
Hamilton, , New Zealand
Wellington, , New Zealand
Lima, , Peru
Lima, , Peru
Lima, , Peru
Lima, , Peru
Lima, , Peru
Lima, , Peru
Lima, , Peru
Miraflores, , Peru
Piura, , Peru
Bialystok, , Poland
Bialystok, , Poland
Bialystok, , Poland
Katowice, , Poland
Kielce, , Poland
Krakow, , Poland
Lublin, , Poland
Poznan, , Poland
Skierniewice, , Poland
Tarnów, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Brasov, , Romania
Brasov, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Cluj-Napoca, , Romania
Craiova, , Romania
Deva, , Romania
Moscow, , Russia
S. Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Smolensk, , Russia
Dnipro, , Ukraine
Dnipropetrovsk, , Ukraine
Dnipropetrovsk, , Ukraine
Ivano-Frankivsk, , Ukraine
Kiev, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Lviv, , Ukraine
Odesa, , Ukraine
Countries
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References
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Harris JM, Maciuca R, Bradley MS, Cabanski CR, Scheerens H, Lim J, Cai F, Kishnani M, Liao XC, Samineni D, Zhu R, Cochran C, Soong W, Diaz JD, Perin P, Tsukayama M, Dimov D, Agache I, Kelsen SG. A randomized trial of the efficacy and safety of quilizumab in adults with inadequately controlled allergic asthma. Respir Res. 2016 Mar 18;17:29. doi: 10.1186/s12931-016-0347-2.
Other Identifiers
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2011-003997-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GB27980
Identifier Type: -
Identifier Source: org_study_id