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
PHASE3
2091 participants
INTERVENTIONAL
2009-02-28
2011-02-28
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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1
Symbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + Symbicort Turbuhaler 160/4.5 µg as needed
Symbicort Turbuhaler
160/4.5 µg
2
Symbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + terbutaline Turbuhaler 0.4 mg as needed
Symbicort Turbuhaler
160/4.5 µg
Terbutaline Turbuhaler
0.4 mg
Interventions
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Symbicort Turbuhaler
160/4.5 µg
Terbutaline Turbuhaler
0.4 mg
Eligibility Criteria
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Inclusion Criteria
* Reversible airway obstruction, defined as an increase in FEV1 ≥12% relative to baseline for all patients 15-30 minutes after inhalation of in total 2 x 0.4 mg terbutaline Turbuhaler
* Prescribed use of inhaled glucocorticoid steroid (GCS) (any brand) for at least 12 weeks.
Exclusion Criteria
* Intake of oral, rectal or parenteral GCS within 4 weeks and/or depot parenteral GCS within 12 weeks.
16 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Tomas Andersson, MD
Role: STUDY_DIRECTOR
AstraZeneca R&D Lund
Tito Atienza, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mary Mediatrix Medical Center, Lipa City, Philippines
Locations
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Research Site
Buenos Aires, Argentina, Argentina
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Capital Federal, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina
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Monte Grande, Buenos Aires, Argentina
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Quilmes, Buenos Aires, Argentina
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Rosario, Santa Fe Province, Argentina
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Santa Fe, Santa Fe Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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Ciudad de Buenos Aires, , Argentina
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Porto Alegre, Brasil, Brazil
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Belo Horizonte, Minas Gerais, Brazil
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Juiz de Fora, Minas Gerais, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Florianópolis, Santa Catarina, Brazil
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Santo André, São Paulo, Brazil
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Shenyang, Liaoning, China
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Hangzhou, Zhejiang, China
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Chongqing, , China
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Guangzhou, , China
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Nanjing, , China
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Qingdao, , China
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Shanghai, , China
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Xi'an, , China
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Tres Ríos, Cartago Province, Costa Rica
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Barrio San Bosco, Provincia de San José, Costa Rica
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Budapest, , Hungary
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Cegléd, , Hungary
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Debrecen, , Hungary
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Deszk, , Hungary
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Gyula, , Hungary
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Nyíregyháza, , Hungary
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Százhalombatta, , Hungary
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Bangalore, Karnataka, India
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Mangalore, Karnataka, India
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Mysore, Karnataka, India
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Trivandrum, Kerala, India
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Mumbai, Maharashtra, India
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Nagpur, Maharashtra, India
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Pune, Maharashtra, India
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Jaipur, Rajasthan, India
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Coimabatore, Tamil Nadu, India
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Noida, , India
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Komaki, Aichi-ken, Japan
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Seto, Aichi-ken, Japan
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Asahi, Chiba, Japan
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Matsuyama, Ehime, Japan
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Fukuoka, Fukuoka, Japan
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Kitakyushu, Fukuoka, Japan
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Yanagawa, Fukuoka, Japan
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Isesaki, Gunma, Japan
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Ōwa, Gunma, Japan
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Fukuyama, Hiroshima, 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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Sapporo, Hokkaido, Japan
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Tomakomai, Hokkaido, Japan
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Ako, Hyōgo, Japan
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Himeji, Hyōgo, Japan
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Kobe, Hyōgo, Japan
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Hitachi, Ibaraki, Japan
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Naka-gun, Ibaraki, Japan
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Morioka, Iwate, Japan
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Sakaidechō, Kagawa-ken, Japan
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Kagoshima, Kagoshima-ken, Japan
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Kawasaki, Kanagawa, Japan
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Kawasaki-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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Sendai, Miyagi, Japan
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Nagaoka, Niigata, Japan
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Niigata, Niigata, Japan
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Beppu, Oita Prefecture, Japan
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Ōita, Oita Prefecture, Japan
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Kurashiki, Okayama-ken, Japan
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Okayama, Okayama-ken, Japan
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Sakai, Osaka, Japan
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Matsue, Shimane, Japan
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Utsunomiya, Tochigi, Japan
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Chūō, Tokyo, Japan
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Kodaira, Tokyo, Japan
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Kokubunji, Tokyo, Japan
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Machida, Tokyo, Japan
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Nakano-ku, Tokyo, Japan
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tabashi City, Tokyo, Japan
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Toshima-ku, Tokyo, Japan
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Kubang Kerian, Kelantan, Malaysia
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Kuantan, Pahang, Malaysia
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Batu Caves, Selangor, Malaysia
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George Town, , Malaysia
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Kuala Lumpur, , Malaysia
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Lima, Lima Province, Peru
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Surco, Lima region, Peru
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Lipa City, Batangas, Philippines
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Davao City, Philippines, Philippines
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Iloilo City, , Philippines
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Manila, , Philippines
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Quezon City, , Philippines
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Bucheon-si, , South Korea
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Cheongju-si, , South Korea
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Seoul, , South Korea
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Suwon, , South Korea
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Bangkoknoi, Bangkok, Thailand
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Hat Yai, Changwat Songkhla, Thailand
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Naimuang, Nakhonratchasima, Thailand
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Bangkok, Thailand, Thailand
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Khon Kaen, , Thailand
Countries
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References
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Zhang O, Minku LL, Gonem S. Detecting asthma exacerbations using daily home monitoring and machine learning. J Asthma. 2021 Nov;58(11):1518-1527. doi: 10.1080/02770903.2020.1802746. Epub 2020 Aug 14.
Other Identifiers
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D589LC00001
Identifier Type: -
Identifier Source: org_study_id