One Month Dose Response Study of AZD1981 in Asthma Patients Uncontrolled on Inhaled Steroids
NCT ID: NCT00758589
Last Updated: 2014-02-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
368 participants
INTERVENTIONAL
2008-09-30
2009-07-31
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
QUADRUPLE
Study Groups
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AZD1981 50 mg
AZD1981 50 mg Twice Daily (Bid)
AZD1981
Oral tablet, 50 mg twice daily
Placebo
Placebo
Placebo
AZD1981 400 mg
AZD1981 400 mg Twice Daily (Bid)
AZD1981
Oral tablet, 400 mg twice daily
AZD1981 1000 mg
AZD1981 1000 mg Twice Daily (Bid)
AZD1981
Oral tablet, 1000 mg twice daily
Interventions
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AZD1981
Oral tablet, 50 mg twice daily
AZD1981
Oral tablet, 400 mg twice daily
AZD1981
Oral tablet, 1000 mg twice daily
Placebo
Eligibility Criteria
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Inclusion Criteria
* Daily use of inhaled glucocorticosteroids
* FEV1 40-85% of predicted normal
* Reversibility; increase in FEV1 more than 12% and 200 mL post-bronchodilator
Exclusion Criteria
* History of smoking of more than 10 pack years
* Respiratory infection within 30 days
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Piotr Kuna
Role: PRINCIPAL_INVESTIGATOR
University of Lodz, Lodz, Poland
Locations
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Research Site
Buenos Aires, Argentina, Argentina
Research Site
Quilmes, Buenos Aires, Argentina
Research Site
Santa Fe, Santa Fe Province, Argentina
Research Site
San Miguel de Tucumán, Tucumán Province, Argentina
Research Site
Porto Alegre, Brasil, Brazil
Research Site
Rio de Janeiro, Rio de Janeiro, Brazil
Research Site
Santo André, São Paulo, Brazil
Research Site
São Paulo, São Paulo, Brazil
Research Site
Barrio Los Yoses, Provincia de San José, Costa Rica
Research Site
San Francisco de Dos Ríos, Provincia de San José, Costa Rica
Research Site
Bialystok, , Poland
Research Site
Bydgoszcz, , Poland
Research Site
Gdalsk, , Poland
Research Site
Kielce, , Poland
Research Site
Krakow, , Poland
Research Site
Lublin, , Poland
Research Site
Poznal, , Poland
Research Site
Szczecin, , Poland
Research Site
Tarnów, , Poland
Research Site
Turek, , Poland
Research Site
Wroclaw, , Poland
Countries
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Other Identifiers
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D9830C00004
Identifier Type: -
Identifier Source: org_study_id
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