Investigation of Efficacy, Safety and Tolerability of Once and Twice Daily Doses of AZD1981 in Asthmatic Patients
NCT ID: NCT01197794
Last Updated: 2013-11-06
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
1144 participants
INTERVENTIONAL
2010-10-31
2012-02-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AZD1981 10 mg
AZD1981 10 mg
AZD1981
AZD1981 twice daily
AZD1981 40 mg
AZD1981 40 mg
AZD1981
AZD1981 twice daily
AZD1981 100 mg
AZD1981 100 mg
AZD1981
AZD1981 twice daily
AZD1981 400 mg
AZD1981 400 mg
AZD1981
AZD1981 twice daily
AZD1981 80 mg
AZD1981 80 mg
AZD1981
AZD1981 once daily
AZD1981 200 mg
AZD1981 200 mg
AZD1981
AZD1981 once daily
Placebo
Placebo
Placebo to match AZD1981
Interventions
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AZD1981
AZD1981 twice daily
AZD1981
AZD1981 once daily
Placebo
Placebo to match AZD1981
Eligibility Criteria
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Inclusion Criteria
* 6 months history of asthma according to ATS definition
* Prescribed daily dose of ICS and LABA for at least 3 months prior to Visit 2
* Pre-bronchodilator FEV1 of 40 to 85 % of predicted normal
* A total ACQ5 score of 1.5 or more
Exclusion Criteria
* Any significant disease and disorder that may put the patient at risk or influence study results
* Any clinically relevant abnormal findings
* A smoking history of more than 10 pack years
* Intake of oral, rectal or parenteral glucocorticosteroids
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Chris O'Brien, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Fullerton, California, United States
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Los Angeles, California, United States
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Mission Viejo, California, United States
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Rolling Hills Estates, California, United States
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San Diego, California, United States
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San Jose, California, United States
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Wheaton, Maryland, United States
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North Dartmouth, Massachusetts, United States
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Bellevue, Nebraska, United States
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Sylvania, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Collegeville, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Charleston, South Carolina, United States
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Clinton, South Carolina, United States
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Waco, Texas, United States
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Tacoma, Washington, United States
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Buenos Aires, Argentina, Argentina
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Quilmes, Buenos Aires, Argentina
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Mendoza, Mendoza Province, Argentina
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Rosario, Santa Fe Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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Porto Alegre, Brasil, Brazil
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Vitória, Espírito Santo, Brazil
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Belo Horizonte, Minas Gerais, Brazil
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Juiz de Fora, Minas Gerais, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Florian Polis, Santa Catarina, Brazil
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Santo André, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Yanagawa, Fukuoka, Japan
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Hiroshima, Hiroshima, Japan
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Asahikawa, Hokkaido, Japan
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Chitose, Hokkaido, Japan
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Kitahiroshima, Hokkaido, Japan
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Obihiro, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Tomakomai, Hokkaido, Japan
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Himeji, Hyōgo, Japan
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Naka-gun, Ibaraki, Japan
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Sakaidechō, Kagawa-ken, Japan
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Fujisawa-shi, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Kochi, Kochi, Japan
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Kyoto, Kyoto, Japan
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Nagaoka, Niigata, Japan
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Beppu, Oita Prefecture, Japan
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Ōita, Oita Prefecture, Japan
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Kurashiki-shi, Okayama-ken, Japan
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Matsue, Shimane, Japan
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Chuo-ku, Tokyo, Japan
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Chūō, Tokyo, Japan
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Itabashi-ku, Tokyo, Japan
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Kodaira, Tokyo, Japan
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Nakano-ku, Tokyo, Japan
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Ohota-ku, Tokyo, Japan
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México, D.f., Mexico
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Tijuana, Estado de Baja California, Mexico
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Morelia, Michoacán, Mexico
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Monterrey, Nuevo León, Mexico
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Guadalajara, , Mexico
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Constanța, Constanța County, Romania
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Brasov, , Romania
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Iași, , Romania
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Tg. Mures, , Romania
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Moscow, Russia, Russia
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Yekaterinburg, Russia, Russia
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Novosibirsk, , Russia
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Saint Petersburg, , Russia
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Vladikavkaz, , Russia
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Banská Bystrica, , Slovakia
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Bardejov, , Slovakia
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Bratislava, , Slovakia
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Dunajská Streda, , Slovakia
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Hnúšťa, , Slovakia
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Komárno, , Slovakia
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Košice, , Slovakia
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Levice, , Slovakia
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Liptovský Hrádok, , Slovakia
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Liptovský Mikuláš, , Slovakia
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Prešov, , Slovakia
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Rimavská Sobota, , Slovakia
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Ružomberok, , Slovakia
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Trenčín, , Slovakia
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Zvolen, , Slovakia
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Lyttleton, Centurion, South Africa
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Durban, KwaZulu-Natal, South Africa
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Cape Town, South Africa, South Africa
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Durban, South Africa, South Africa
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eMkhomazi, South Africa, South Africa
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Durbanville, , South Africa
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eManzimtoti, , South Africa
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Pretoria, , South Africa
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Dnipropetrovsk, , Ukraine
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Donetsk, , Ukraine
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Kharkiv, , Ukraine
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Kyiv, , Ukraine
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Odesa, , Ukraine
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Poltava, , Ukraine
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Vinytsa, , Ukraine
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Zaporizhzhya, , Ukraine
Countries
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References
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Bateman ED, O'Brien C, Rugman P, Luke S, Ivanov S, Uddin M. Efficacy and safety of the CRTh2 antagonist AZD1981 as add-on therapy to inhaled corticosteroids and long-acting beta2-agonists in patients with atopic asthma. Drug Des Devel Ther. 2018 May 4;12:1093-1106. doi: 10.2147/DDDT.S147389. eCollection 2018.
Other Identifiers
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2010-020407-73
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D9830C00008
Identifier Type: -
Identifier Source: org_study_id