A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma.
NCT ID: NCT02149199
Last Updated: 2019-11-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
3850 participants
INTERVENTIONAL
2014-07-07
2017-08-02
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
TRIPLE
Study Groups
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Symbicort "as needed"+placebo Pulmicort bid
Symbicort (budesonide/formoterol) Turbuhaler 160/4.5 μg 'as needed' + Placebo Pulmicort Turbuhaler 200 μg bid
budesonide/formoterol 'as needed' + budesonide placebo bid
Symbicort (budesonide/ formoterol) 160/4.5 μg powder for inhalation 'as needed' plus Pulmicort placebo 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening), 52-week treatment
terbutaline "as needed"+placebo Pulmicort bid
terbutaline Turbuhaler 0.4 mg 'as needed' + placebo Pulmicort 200 μg Turbuhaler bid
terbutaline 'as needed' + placebo budesonide bid
Terbutaline 0.4 mg powder for inhalation 'as needed' plus placebo Pulmicort (budesonide) 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening), 52-week treatment
Pulmicort bid + terbutaline "as needed"
Pulmicort 200 μg Turbuhaler bid + terbutaline 0.4 mg Turbuhaler 'as needed'
budesonide bid + terbutaline 'as needed'
Pulmicort (budesonide) 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening) plus terbutaline 0.4 mg powder for inhalation 'as needed', 52-week treatment
Interventions
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budesonide/formoterol 'as needed' + budesonide placebo bid
Symbicort (budesonide/ formoterol) 160/4.5 μg powder for inhalation 'as needed' plus Pulmicort placebo 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening), 52-week treatment
terbutaline 'as needed' + placebo budesonide bid
Terbutaline 0.4 mg powder for inhalation 'as needed' plus placebo Pulmicort (budesonide) 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening), 52-week treatment
budesonide bid + terbutaline 'as needed'
Pulmicort (budesonide) 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening) plus terbutaline 0.4 mg powder for inhalation 'as needed', 52-week treatment
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
12 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Paul M O'Byrne, MB, FRCP(C), FRSC
Role: PRINCIPAL_INVESTIGATOR
McMaster University, Hamilton, Canada
Locations
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Bedford Park, , Australia
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Concord, , Australia
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Maroubra, , Australia
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Murdoch, , Australia
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Wollongong, , Australia
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Alphaville, , Brazil
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Botucatu, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Salvador, , Brazil
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Santo André, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Sorocaba, , Brazil
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Dupnitsa, , Bulgaria
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Gotse Delchev, , Bulgaria
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Kozloduy, , Bulgaria
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Pazardzhik, , Bulgaria
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Plovdiv, , Bulgaria
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Razgrad, , Bulgaria
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Roman, , Bulgaria
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Rousse, , Bulgaria
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Sandanski, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Velingrad, , Bulgaria
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Vratsa, , Bulgaria
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Edmonton, Alberta, Canada
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Sherwood Park, Alberta, Canada
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Maple Ridge, British Columbia, Canada
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North Vancouver, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Mount Pearl, Newfoundland and Labrador, Canada
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St. John's, Newfoundland and Labrador, Canada
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Ajax, Ontario, Canada
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Burlington, Ontario, Canada
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Cornwall, Ontario, Canada
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Etobicoke, Ontario, Canada
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Hamilton, Ontario, Canada
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Kanata, Ontario, Canada
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London, Ontario, Canada
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Mississauga, Ontario, Canada
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Newmarket, Ontario, Canada
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North York, Ontario, Canada
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Ottawa, Ontario, Canada
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Sarnia, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Windsor, Ontario, Canada
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Lévis, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Pointe-Claire, Quebec, Canada
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Québec, Quebec, Canada
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Québec, Quebec, Canada
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Québec, Quebec, Canada
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Québec, Quebec, Canada
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Saint-Charles-Borromée, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Victoriaville, Quebec, Canada
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Quillota, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Talcahuano, , Chile
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Beijing, , China
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Beijing, , China
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Changsha, , China
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Chengdu, , China
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Chengdu, , China
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Guangzhou, , China
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Guangzhou, , China
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Haikou, , China
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Hohhot, , China
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Nanchang, , China
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Shanghai, , China
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Shanghai, , China
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Shanghai, , China
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Shanghai, , China
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Shanghai, , China
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Shanghai, , China
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Shenyang, , China
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Wenzhou, , China
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Wuhan, , China
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Xi'an, , China
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Xi'an, , China
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Xiamen, , China
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Xuzhou, , China
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Balassagyarmat, , Hungary
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Berettyóújfalu, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Edelény, , Hungary
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Hajdúnánás, , Hungary
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Mátészalka, , Hungary
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Miskolc, , Hungary
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Monor, , Hungary
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Nyírbátor, , Hungary
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Nyíregyháza, , Hungary
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Pécs, , Hungary
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Pécs, , Hungary
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Szeged, , Hungary
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D.F., , Mexico
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Durango, , Mexico
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México, , Mexico
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México, , Mexico
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México, , Mexico
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Monterrey, , Mexico
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Morelia, , Mexico
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Villahermosa, , Mexico
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Cusco, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Piura, , Peru
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Surco, , Peru
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Lipa City, , Philippines
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Manila, , Philippines
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Manila, , Philippines
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Pasig, , Philippines
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Quezon City, , Philippines
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Bialystok, , Poland
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Bialystok, , Poland
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Elblag, , Poland
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Grodzisk Mazowiecki, , Poland
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Grudziądz, , Poland
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Kielce, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lodz, , Poland
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Lodz, , Poland
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Poznan, , Poland
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Poznan, , Poland
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Rzeszów, , Poland
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Rzeszów, , Poland
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Skierniewice, , Poland
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Strzelce Opolskie, , Poland
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Szczecin, , Poland
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Szczecin, , Poland
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Słupca, , Poland
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Tarnów, , Poland
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Trzebnica, , Poland
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Turek, , Poland
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Zabrze, , Poland
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Bragadiru, , Romania
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Brasov, , Romania
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Brasov, , Romania
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Cluj-Napoca, , Romania
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Constanța, , Romania
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Piteşti, , Romania
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Timișoara, , Romania
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Chelyabinsk, , Russia
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Gatchina, , Russia
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Ivanovo, , Russia
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Kazan', , Russia
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Kemerovo, , Russia
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Kemerovo, , Russia
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Krasnoyarsk, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Nizhny Novgorod, , Russia
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Novosibirsk, , Russia
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Novosibirsk, , Russia
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Penza, , Russia
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Perm, , Russia
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Perm, , Russia
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Petrozavodsk, , Russia
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Pyatigorsk, , Russia
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Ryazan, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saratov, , Russia
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Ulyanovsk, , Russia
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Vladikavkaz, , Russia
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Volgograd, , Russia
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Volgograd, , Russia
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Voronezh, , Russia
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Yaroslavl, , Russia
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Yaroslavl, , Russia
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Yekaterinburg, , Russia
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Yekaterinburg, , Russia
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Yekaterinburg, , Russia
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Boksburg North, , South Africa
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Durban, , South Africa
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Durban, , South Africa
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Durban, , South Africa
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Johannesburg, , South Africa
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Johannesburg, , South Africa
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KwaDukuza, , South Africa
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Middelburg, , South Africa
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Queenswood, , South Africa
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Verulam, , South Africa
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Bucheon-si, , South Korea
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Cheongju-si, , South Korea
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Cheongju-si, , South Korea
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Incheon, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Cherkasy, , Ukraine
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Dnipropetrovsk, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kharkiv, , Ukraine
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Kharkiv, , Ukraine
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Kharkiv, , Ukraine
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Kharkiv, , Ukraine
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Kharkiv, , Ukraine
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Kharkiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Lutsk, , Ukraine
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Lutsk, , Ukraine
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Lviv, , Ukraine
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Odesa, , Ukraine
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Vinnytsia, , Ukraine
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Zaporizhzhya, , Ukraine
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Bath, , United Kingdom
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Coventry, , United Kingdom
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Mortimer Reading, , United Kingdom
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Royal Leamington Spa, , United Kingdom
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Trowbridge, , United Kingdom
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Haiphong, , Vietnam
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Hanoi, , Vietnam
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Ho Chi Minh City, , Vietnam
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Ho Chi Minh City, , Vietnam
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Hochiminh, , Vietnam
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Đông Nãi, , Vietnam
Countries
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References
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FitzGerald JM, O'Byrne PM, Bateman ED, Barnes PJ, Zheng J, Ivanov S, Lamarca R, Larsdotter U, Emerath U, Jansen G, Puu M, Alagappan VKT, Surmont F, Reddel HK. Safety of As-Needed Budesonide-Formoterol in Mild Asthma: Data from the Two Phase III SYGMA Studies. Drug Saf. 2021 Apr;44(4):467-478. doi: 10.1007/s40264-020-01041-z. Epub 2021 Feb 6.
O'Byrne PM, FitzGerald JM, Bateman ED, Barnes PJ, Zheng J, Gustafson P, Lamarca R, Puu M, Keen C, Alagappan VKT, Reddel HK. Effect of a single day of increased as-needed budesonide-formoterol use on short-term risk of severe exacerbations in patients with mild asthma: a post-hoc analysis of the SYGMA 1 study. Lancet Respir Med. 2021 Feb;9(2):149-158. doi: 10.1016/S2213-2600(20)30416-1. Epub 2020 Oct 1.
O'Byrne PM, FitzGerald JM, Bateman ED, Barnes PJ, Zhong N, Keen C, Jorup C, Lamarca R, Ivanov S, Reddel HK. Inhaled Combined Budesonide-Formoterol as Needed in Mild Asthma. N Engl J Med. 2018 May 17;378(20):1865-1876. doi: 10.1056/NEJMoa1715274.
O'Byrne PM, FitzGerald JM, Zhong N, Bateman E, Barnes PJ, Keen C, Almqvist G, Pemberton K, Jorup C, Ivanov S, Reddel HK. The SYGMA programme of phase 3 trials to evaluate the efficacy and safety of budesonide/formoterol given 'as needed' in mild asthma: study protocols for two randomised controlled trials. Trials. 2017 Jan 10;18(1):12. doi: 10.1186/s13063-016-1731-4.
Reddel HK, Busse WW, Pedersen S, Tan WC, Chen YZ, Jorup C, Lythgoe D, O'Byrne PM. Should recommendations about starting inhaled corticosteroid treatment for mild asthma be based on symptom frequency: a post-hoc efficacy analysis of the START study. Lancet. 2017 Jan 14;389(10065):157-166. doi: 10.1016/S0140-6736(16)31399-X. Epub 2016 Nov 30.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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D589SC00001-statistical-analysis-plan-edition-4\_29Sep2017\_pdfa
Other Identifiers
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2013-004474-96
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D589SC00001
Identifier Type: -
Identifier Source: org_study_id
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