- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01444430
A 6 Month Safety Study Comparing Symbicort With Inhaled Corticosteroid Only in Asthmatic Adults and Adolescents
A 26 Week, Randomized, Double-blind, Parallel-group, Active Controlled, Multicenter, Multinational Safety Study Evaluating the Risk of Serious Asthma-related Events During Treatment With Symbicort®, a Fixed Combination of Inhaled Corticosteroid (ICS) (Budesonide) and a Long Acting β2-agonist (LABA) (Formoterol) as Compared to Treatment With ICS (Budesonide) Alone in Adult and Adolescent (≥12 Years of Age) Patients With Asthma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Buenos Aires, Argentina
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Ciudad de Buenos Aires, Argentina
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Córdoba, Argentina
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Mar del Plata, Argentina
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Monte Grande, Argentina
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Quilmes, Argentina
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Ranelagh, Argentina
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San Miguel de Tucuman, Argentina
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San Miguel de Tucumán, Argentina
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Barueri, Brazil
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Botucatu, Brazil
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Goiania, Brazil
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Juiz de Fora, Brazil
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Porto Alegre, Brazil
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Santo André, Brazil
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Sao Paulo, Brazil
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Gotse Delchev, Bulgaria
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Kozloduy, Bulgaria
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Petrich, Bulgaria
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Pleven, Bulgaria
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Razgrad, Bulgaria
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Razlog, Bulgaria
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Ruse, Bulgaria
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Sandanski, Bulgaria
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Sevlievo, Bulgaria
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Sofia, Bulgaria
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Stara Zagora, Bulgaria
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Varna, Bulgaria
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Vidin, Bulgaria
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Quillota, Chile
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Santiago, Chile
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Vina del Mar, Chile
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Bogotá, Colombia
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Cali, Colombia
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Manizales, Colombia
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Beroun, Czech Republic
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Breclav, Czech Republic
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Krnov, Czech Republic
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Kutna Hora, Czech Republic
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Litomerice, Czech Republic
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Ostrava, Czech Republic
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Plzen, Czech Republic
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Praha 10, Czech Republic
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Praha 4, Czech Republic
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Praha 8, Czech Republic
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Rokycany, Czech Republic
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Angers, France
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Perpignan, France
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Tierce, France
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Berlin, Germany
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Hamburg, Germany
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Leipzig, Germany
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Marburg, Germany
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Bangalore, India
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Calicut, India
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Coimbatore, India
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Goa, India
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Hyderabad, India
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Mangalore, India
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Mysore, India
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Nagpur, India
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New Delhi, India
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Trivandrum, India
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Benevento, Italy
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Bologna, Italy
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Catanzaro, Italy
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Ferrara, Italy
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Genova, Italy
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Napoli, Italy
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Padova, Italy
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Palermo, Italy
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Roma, Italy
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Ansan-si, Korea, Republic of
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Cheonan-si, Korea, Republic of
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Cheongju-si, Korea, Republic of
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Jinju-si, Korea, Republic of
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Seongnam-si, Korea, Republic of
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Seoul, Korea, Republic of
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Durango, Mexico
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Guadalajara, Mexico
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Mexico, Mexico
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Monterey, Mexico
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Monterrey, Mexico
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Morelia, Mexico
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México, Mexico
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Santiago de Querétaro, Mexico
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Villahermosa, Mexico
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Zapopan, Mexico
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Ciudad de Panama, Panama
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Cusco, Peru
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Lima, Peru
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Iloilo City, Philippines
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Lipa City, Philippines
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Manila, Philippines
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Pasig City, Philippines
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Quezon City, Philippines
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Białystok, Poland
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Bydgoszcz, Poland
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Chęciny, Poland
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Gorzów Wlkp, Poland
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Karpacz, Poland
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Kraków, Poland
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Ostrów Wielkopolski, Poland
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Skarżysko Kamienna, Poland
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Strzelce Opolskie, Poland
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Szczecin, Poland
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Tarnów, Poland
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Turek, Poland
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Urszulin, Poland
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Wrocław, Poland
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Caguas, Puerto Rico
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San Juan, Puerto Rico
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Toa Baja, Puerto Rico
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Bragadiru, Romania
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Brasov, Romania
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Bucharest, Romania
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Bucuresti, Romania
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Cluj Napoca, Romania
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Constanta, Romania
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Craiova, Romania
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Deva, Romania
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Iasi, Romania
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Tg. Mures, Romania
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Ekaterinburg, Russian Federation
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Kazan, Russian Federation
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Moscow, Russian Federation
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Novosibirsk, Russian Federation
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Penza, Russian Federation
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Saint Petersburg, Russian Federation
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Saint-Petersburg, Russian Federation
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Saratov, Russian Federation
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St-Petersburg, Russian Federation
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St. Petersburg, Russian Federation
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StPetersburg, Russian Federation
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Vladikavkaz, Russian Federation
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Volgograd, Russian Federation
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Yaroslavl, Russian Federation
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Yekaterinburg, Russian Federation
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Bardejov, Slovakia
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Bratislava, Slovakia
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Dunajska Streda, Slovakia
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Komarno, Slovakia
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Kosice, Slovakia
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Liptovsky Mikulas, Slovakia
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Nitra, Slovakia
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Presov, Slovakia
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Ruzomberok, Slovakia
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Skalica, Slovakia
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Zilina, Slovakia
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Zvolen, Slovakia
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Boksburg North, South Africa
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Breyton, South Africa
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Cape Town, South Africa
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Durban, South Africa
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Johannesburg, South Africa
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Lenasia, South Africa
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Lyttleton, South Africa
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Pretoria, South Africa
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Umkomaas, South Africa
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Verulam, South Africa
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Bangkok, Thailand
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Hat Yai, Thailand
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Khon Kaen, Thailand
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Muang,, Thailand
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Naimuang, Thailand
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Dnipropetrovsk, Ukraine
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Donetsk, Ukraine
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Ivano-Frankivsk, Ukraine
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Kharkiv, Ukraine
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Kiev, Ukraine
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Odesa, Ukraine
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Poltava, Ukraine
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Uzhgorod, Ukraine
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Vinnitsa, Ukraine
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Zaporozye, Ukraine
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Bath, United Kingdom
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Belfast, United Kingdom
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Blackpool, United Kingdom
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Canterbury, United Kingdom
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Chippenham, United Kingdom
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Coventry, United Kingdom
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Crawley, United Kingdom
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Leamington Spa, United Kingdom
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Leicester, United Kingdom
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Stockport, United Kingdom
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Trowbridge, United Kingdom
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Watford, United Kingdom
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Westbury, United Kingdom
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Alabama
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Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Alaska
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Anchorage, Alaska, United States
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Arizona
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Gilbert, Arizona, United States
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Glendale, Arizona, United States
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Mesa, Arizona, United States
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Tucson, Arizona, United States
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Arkansas
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Fort Smith, Arkansas, United States
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Little Rock, Arkansas, United States
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California
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Alhambra, California, United States
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Anaheim, California, United States
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Arvin, California, United States
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Bellflower, California, United States
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Buena Park, California, United States
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Costa Mesa, California, United States
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Encinitas, California, United States
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Escondido, California, United States
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Fountain Valley, California, United States
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Glendale, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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Northridge, California, United States
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Palmdale, California, United States
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Pasadena, California, United States
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Poway, California, United States
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Riverside, California, United States
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Roseville, 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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Santa Ana, California, United States
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Stockton, California, United States
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Tustin, California, United States
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Walnut Creek, California, United States
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Colorado
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Denver, Colorado, United States
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Thornton, Colorado, United States
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Connecticut
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Norwalk, Connecticut, United States
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Waterbury, Connecticut, United States
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Florida
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Altamonte Springs, Florida, United States
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Clearwater, Florida, United States
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DeLand, Florida, United States
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Fort Lauderdale, Florida, United States
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Fort Myers, Florida, United States
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Gainesville, Florida, United States
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Hialeah, Florida, United States
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Jacksonville, Florida, United States
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Kissimmee, Florida, United States
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Leesburg, Florida, United States
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Lehigh Acres, Florida, United States
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Lynn Haven, Florida, United States
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Miami, Florida, United States
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Miami Beach, Florida, United States
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Ocoee, Florida, United States
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Opalocka, Florida, United States
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Orlando, Florida, United States
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Pembroke Pines, Florida, United States
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Royal Palm Beach, Florida, United States
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Tampa, Florida, United States
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Georgia
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Calhoun, Georgia, United States
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Conyers, Georgia, United States
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Decatur, Georgia, United States
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Gainesville, Georgia, United States
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Savannah, Georgia, United States
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Idaho
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Hayden Lake, Idaho, United States
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Meridan, Idaho, United States
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Illinois
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Kenilworth, Illinois, United States
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Springfield, Illinois, United States
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Indiana
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Anderson, Indiana, United States
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Evansville, Indiana, United States
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Michigan City, Indiana, United States
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Iowa
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Ames, Iowa, United States
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Council Bluffs, Iowa, United States
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Kentucky
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Fort Mitchell, Kentucky, United States
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Lexington, Kentucky, United States
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Owensboro, Kentucky, United States
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Louisiana
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Lafayette, Louisiana, United States
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Lake Charles, Louisiana, United States
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Shreveport, Louisiana, United States
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Maryland
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Baltimore, Maryland, United States
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Lanham, Maryland, United States
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Massachusetts
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Watertown, Massachusetts, United States
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Michigan
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Kalamazoo, Michigan, United States
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Madison Hgts, Michigan, United States
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Port Huron, Michigan, United States
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Southfield, Michigan, United States
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Sterling Heights, Michigan, United States
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Ypsilanti, Michigan, United States
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Minnesota
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Duluth, Minnesota, United States
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Edina, Minnesota, United States
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Mississippi
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Biloxi, Mississippi, United States
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Jackson, Mississippi, United States
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Vicksburg, Mississippi, United States
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Missouri
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Bridgeton, Missouri, United States
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Chesterfield, Missouri, United States
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Kansas City, Missouri, United States
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Springfield, Missouri, United States
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St Louis, Missouri, United States
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Nebraska
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Bellevue, Nebraska, United States
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Grand Island, Nebraska, United States
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Omaha, Nebraska, United States
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New Jersey
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Verona, New Jersey, United States
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New York
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Bronx, New York, United States
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Great Neck, New York, United States
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Hopewell Jct, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Rockville Centre, New York, United States
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Watertown, New York, United States
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North Carolina
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Cary, North Carolina, United States
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Charlotte, North Carolina, United States
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Greensboro, North Carolina, United States
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Salisbury, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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North Dakota
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Fargo, North Dakota, United States
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Ohio
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Cincinnati, Ohio, United States
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Miamishburg, Ohio, United States
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Stow, Ohio, United States
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Oklahoma
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Oklahoma City, Oklahoma, United States
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Oregon
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Bend, Oregon, United States
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Pennsylvania
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Abington, Pennsylvania, United States
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Bryn Mawr, Pennsylvania, United States
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Doylestown, Pennsylvania, United States
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Phoenixville, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Wyomissing, Pennsylvania, United States
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Rhode Island
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Warwick, Rhode Island, United States
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South Carolina
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Charleston, South Carolina, United States
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Greeneville, South Carolina, United States
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Greenville, South Carolina, United States
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Greer, South Carolina, United States
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Indian Land, South Carolina, United States
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Summerville, South Carolina, United States
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Tennessee
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Knoxville, Tennessee, United States
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Nashville, Tennessee, United States
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Texas
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Austin, Texas, United States
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Baytown, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Georgetown, Texas, United States
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Houston, Texas, United States
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Killeen, Texas, United States
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McKinney, Texas, United States
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Pharr, Texas, United States
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Plano, Texas, United States
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San Antonio, Texas, United States
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Spring, Texas, United States
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Sugar Land, Texas, United States
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Sugarland, Texas, United States
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Waco, Texas, United States
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Utah
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Layton, Utah, United States
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Vermont
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South Burlington, Vermont, United States
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Virginia
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Danville, Virginia, United States
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Vienna, Virginia, United States
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Virginia Beach, Virginia, United States
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Washington
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Seattle, Washington, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Wisconsin
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La Crosse, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Hanoi, Vietnam
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Ho Chi Minh, Vietnam
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Provision of signed informed consent/ paediatric assent (if applicable) prior to any study specific procedures including medication withdrawal
- Male or Female, ≥12 years of age
- Documented clinical diagnosis of asthma for at least 1 year prior to Visit 2
Patient must have history of at least 1 asthma exacerbation including one of the following:
- requiring treatment with systemic corticosteroids
- an asthma-related hospitalization between 4 weeks and 12 months prior to randomization
- Current Asthma Therapy: Patients must be appropriately using one of the treatments for asthma listed in the protocol combined with achieving certain results when recording an Asthma Control Questionnaire
Exclusion Criteria:
- Patient has a history of life-threatening asthma. Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea requiring non-invasive ventilatory support.
- Patient has required treatment with systemic corticosteroids (tablets, suspensions or injectable) for any reason within 4 weeks prior to Visit 2
- Patient has an ongoing exacerbation, defined as a worsening of asthma that requires treatment with systemic corticosteroids (tablets, suspension, or injectable)
- An asthma exacerbation within 4 weeks of randomization or more than 4 separate exacerbations in the 12 months preceding randomization or more than 2 hospitalizations for treatment of asthma in the 12 months preceding randomization
- Patient has a respiratory infection or other viral/bacterial illness, or is recovering from such an illness at the time of Visit 2 that, in the investigator's opinion, will interfere with the patient's lung function
- Patient must not meet unstable asthma severity criteria as listed in the protocol
- Peak expiratory flow must not be below 50% o predicted normal
- Pregnancy, breast-feeding or planned pregnancy during the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: 2
budesonide
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Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening), for oral inhalation.
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Experimental: 1
Symbicort
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Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening), for oral inhalation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization)
Time Frame: Up to 27 weeks
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Number of participants experiencing an event in the composite endpoint (asthma-related death, asthma-related intubation or asthma-related hospitalization), using events adjudicated and confirmed by the Joint Adjudication Committee.
Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide.
Hazard ratios and 95% confidence intervals were estimated.
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Up to 27 weeks
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Number of Participants Experiencing an Event Included in the Definition of Asthma Exacerbation
Time Frame: Up to 26 weeks
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Number of participants experiencing an event included in the definition of asthma exacerbation.
An asthma exacerbation was defined as a deterioration of asthma requiring systemic corticosteroids for at least 3 days or an inpatient hospitalization or emergency room visit due to asthma that required systemic corticosteroids.
Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide.
Hazard ratios and 95% confidence intervals were estimated.
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Up to 26 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of Days With no Asthma Symptoms
Time Frame: Daily up to 26 weeks
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Percent of days with no asthma symptoms during the randomized treatment period.
Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.
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Daily up to 26 weeks
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Percent of Days With Activity Limitation Due to Asthma
Time Frame: Daily up to 26 weeks
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Percent of days with activity limitation due to asthma during the randomized treatment period.
Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.
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Daily up to 26 weeks
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Mean Number of Puffs of Rescue Medication Per 24 Hours
Time Frame: Daily up to 26 weeks
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Mean number of puffs of rescue medication per day (24 hours) during the randomized treatment period.
Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.
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Daily up to 26 weeks
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Asthma Control Questionnaire (ACQ6)
Time Frame: baseline, day 28, day 84, day 182
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The outcome variable for ACQ6 was the difference between the average of values recorded during the treatment period (day 28, day 84 and day 182) and the baseline measure. Analysis of covariance (ANCOVA) model, including the fixed factors of treatment and strata by incoming control/asthma treatment and baseline ACQ6 as covariate was used to compare Symbicort and budesonide. The asthma control questionnaire, ACQ6, consists of six questions; all assessed on a 7-point scale from 0 to 6, where 0 represents good control and 6 represents poor control. The overall score is the mean of the responses to each of the six questions. |
baseline, day 28, day 84, day 182
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Percent of Nights With Awakening(s) Due to Asthma
Time Frame: Daily up to 26 weeks
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Percent of nights with awakening(s) due to asthma during the randomized treatment period.
Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.
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Daily up to 26 weeks
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Number of Participants Experiencing Discontinuation of Investigational Product Due to a Protocol Defined Asthma Exacerbation
Time Frame: Up to 26 weeks
|
Number of participants experiencing discontinuation of investigational product due to a protocol defined asthma exacerbation.
An asthma exacerbation was defined as a deterioration of asthma requiring systemic corticosteroids for at least 3 days or an inpatient hospitalization or emergency room visit due to asthma that required systemic corticosteroids.
Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide.
Hazard ratios and 95% confidence intervals were estimated.
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Up to 26 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Carin Jorup, AstraZeneca Pepparedsleden 1, 431 83 Mölndal
Publications and helpful links
Helpful Links
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
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Budesonide
- Budesonide, Formoterol Fumarate Drug Combination
Other Study ID Numbers
- D5896C00027
- 2011-002790-28 (EudraCT Number)
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.
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