A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma
NCT ID: NCT02224157
Last Updated: 2019-11-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
4215 participants
INTERVENTIONAL
2014-11-28
2017-08-16
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
Pulmicort bid + terbutaline "as needed"
Pulmicort 200 μg Turbuhaler bid + terbutaline 0.4 mg Turbuhaler 'as needed'
budesonode 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
budesonode 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
2. Male or Female, ≥12 years of age
3. Documented diagnosis of asthma for at least 6 months prior to Visit 1
4. Patients who are in need of GINA step 2 treatment
5. Patients treated with a short acting inhaled bronchodilator(s) only should have pre-bronchodilator FEV1 ≥ 60 % of predicted normal (PN) and post-bronchodilator FEV1 ≥ 80 % PN
6. Patients treated with low stable dose of ICS or leukotriene antagonists in addition to short acting inhaled bronchodilator(s) should have pre-bronchodilator FEV1 ≥80 % PN
7. Patients should have reversible airway obstruction
8. To be randomized patients must have used Bricanyl Turbuhaler as needed on at least 3 separate days during the last week of the run in period
Exclusion Criteria
2. Patient has had an asthma worsening requiring change in treatment other than short acting inhaled bronchodilator(s) within 30 days prior to Visit 1 and from Visit 1 until randomization
3. Patient has required treatment with oral, rectal or parenteral GCS within 30 days and/or depot parenteral GCS within 12 weeks prior to Visit 1
4. Current or previous smoker with a smoking history of ≥ 10 pack years
5. Pregnancy, breast-feeding or planned pregnancy during the study
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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Carin Jorup, MD
Role: STUDY_DIRECTOR
AstraZeneca Research & Development
Locations
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Sydney, , Australia
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Botucatu, , Brazil
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Florianópolis, , Brazil
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Goiânia, , 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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São Paulo, , Brazil
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Sorocaba, , Brazil
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Blagoevgrad, , Bulgaria
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Pernik, , Bulgaria
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Petrich, , Bulgaria
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Pleven, , Bulgaria
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Razlog, , Bulgaria
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Sliven, , Bulgaria
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Smolyan, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Stara Zagora, , Bulgaria
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Varna, , Bulgaria
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Veliko Tarnovo, , Bulgaria
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Vidin, , Bulgaria
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Yambol, , Bulgaria
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Curicó, , Chile
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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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Talca, , Chile
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Viña del Mar, , Chile
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Barranquilla, , Colombia
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Bogotá, , Colombia
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Bogotá, , Colombia
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Bogotá, , Colombia
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Medellín, , Colombia
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Česká Lípa, , Czechia
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Kladno, , Czechia
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Kralupy nad Vltavou, , Czechia
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Kutná Hora, , Czechia
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Liberec, , Czechia
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Neratovice, , Czechia
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Ostrava, , Czechia
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Ostrava, , Czechia
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Pardubice, , Czechia
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Pilsen, , Czechia
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Pilsen, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Rokycany, , Czechia
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Rudna U Prahy, , Czechia
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Tábor, , Czechia
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Teplice, , Czechia
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Žatec, , Czechia
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Brii-sous-forges, , France
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Colmar, , France
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Joué-lès-Tours, , France
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Nantes, , France
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Nîmes, , France
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Rezé, , France
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Bad Lippspringe, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Cottbus, , Germany
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Frankfurt am Main, , Germany
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Geesthacht, , Germany
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Großhansdorf, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Leipzig, , Germany
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Leipzig, , Germany
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Lübeck, , Germany
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Neu-Isenburg, , Germany
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Oldenburg, , Germany
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Reinfeld, , Germany
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Rüdersdorf, , Germany
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Schleswig, , Germany
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Warendorf, , Germany
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Aszód, , Hungary
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Balassagyarmat, , Hungary
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Berettyóújfalu, , Hungary
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Budapest, , Hungary
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Cegléd, , Hungary
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Gyula, , Hungary
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Létavértes, , Hungary
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Makó, , Hungary
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Pécs, , Hungary
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Newtown, , New Zealand
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Rotorua, , New Zealand
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Tauranga, , New Zealand
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Wellington, , New Zealand
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Chancay, , Peru
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Lima, , Peru
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Miraflores, , Peru
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Santa Beatriz, , Peru
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Lipa City, , 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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Giżycko, , Poland
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Kościan, , Poland
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Krakow, , Poland
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Lublin, , Poland
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Mrągowo, , Poland
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Ostrowiec Świętokrzyski, , Poland
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Ostrów Wielkopolski, , Poland
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Pabianice, , Poland
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Piła, , Poland
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Poznan, , Poland
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Proszowice, , Poland
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Zabrze, , Poland
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Bragadiru, , Romania
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Perm, , Russia
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Ulyanovsk, , Russia
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Vsevolozhsk, , Russia
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Yekaterinburg, , Russia
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Dhahran, , Saudi Arabia
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Jeddah, , Saudi Arabia
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Jeddah, , Saudi Arabia
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Riyadh, , Saudi Arabia
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Riyadh, , Saudi Arabia
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Kežmarok, , Slovakia
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Komárno, , Slovakia
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Košice, , Slovakia
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Košice, , Slovakia
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Levice, , Slovakia
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Liptovský Mikuláš, , Slovakia
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Nitra, , Slovakia
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Nové Zámky, , Slovakia
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Poprad, , Slovakia
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Poprad, , Slovakia
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Rimavská Sobota, , Slovakia
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Skalica, , Slovakia
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Topoľčany, , Slovakia
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Trebišov, , Slovakia
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Zvolen, , Slovakia
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Žilina, , Slovakia
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Bellville, , South Africa
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Verulam, , South Africa
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Busan, , South Korea
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Suwon, , South Korea
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Uijeongbu-si, , South Korea
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Wŏnju, , South Korea
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Alicante, , Spain
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Badalona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Bilbao (Vizcaya), , Spain
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Madrid, , Spain
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Marbella (Málaga), , Spain
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Málaga, , Spain
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Oviedo, , Spain
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Seville, , Spain
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Seville, , Spain
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Terrassa (Barcelona), , Spain
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Valencia, , Spain
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Borås, , Sweden
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Lund, , Sweden
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Malmo, , Sweden
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Stockholm, , Sweden
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Värnamo, , Sweden
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Västra Frölunda, , Sweden
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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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Nonthaburi, , Thailand
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Pathum Thani, , Thailand
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Cherkasy, , Ukraine
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Chernihiv, , Ukraine
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Chernivtsi, , Ukraine
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Dnipro, , Ukraine
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Ivano-Frankivsk, , 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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Kherson, , Ukraine
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Kyiv, , 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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Lviv, , Ukraine
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Odesa, , Ukraine
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Odesa, , Ukraine
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Ternopil, , Ukraine
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Uzhhorod, , Ukraine
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Uzhhorod, , Ukraine
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Uzhhorod, , Ukraine
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Vinnytsia, , Ukraine
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Zaporizhzhya, , Ukraine
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Zaporizhzhya, , Ukraine
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Can Tho, , Vietnam
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Hanoi, , Vietnam
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Hà Nội, , Vietnam
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Ho Chi Minh City, , Vietnam
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Hochiminh, , Vietnam
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Huế, , Vietnam
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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.
Bateman ED, Reddel HK, O'Byrne PM, Barnes PJ, Zhong N, Keen C, Jorup C, Lamarca R, Siwek-Posluszna A, FitzGerald JM. As-Needed Budesonide-Formoterol versus Maintenance Budesonide in Mild Asthma. N Engl J Med. 2018 May 17;378(20):1877-1887. doi: 10.1056/NEJMoa1715275.
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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D589SC00003-revised-csp-edition-4\_12Oct2016\_Redacted\_pdfa
D589SC00003-statistical-analysis-plan-edition-2\_06SEP2017\_pdfa
Other Identifiers
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2013-004473-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D589SC00003
Identifier Type: -
Identifier Source: org_study_id
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