A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma (SYGMA2)
November 6, 2019 updated by: AstraZeneca
A Clinical Study Comparing Symbicort 'as Needed' With Pulmicort Twice Daily Plus Terbutaline 'as Needed' in Adult and Adolescent Patients With Asthma
The purpose of this study is to test if Symbicort (budesonide/formoterol) Turbuhaler is effective in treating asthma when used 'as needed' in patients with milder asthma.
The efficacy of Symbicort 'as needed' will be compared with Pulmicort (budesonide) Turbuhaler twice daily plus terbutaline Turbuhaler 'as needed'
Study Overview
Status
Completed
Conditions
Detailed Description
A 52-week, double-blind, randomised, multi-centre, phase III, parallel-group study in patients 12 years and older with asthma, evaluating the efficacy and safety of Symbicort (budesonide/formoterol) Turbuhaler 160/4.5 μg 'as needed' compared with Pulmicort (budesonide) Turbuhaler 200 μg twice daily plus terbutaline Turbuhaler 0.4 mg 'as needed'
Study Type
Interventional
Enrollment (Actual)
4215
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Sydney, Australia, 2010
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Botucatu, Brazil, 18618-970
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Florianopolis, Brazil, 88040-970
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Goiania, Brazil, 74110 030
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Porto Alegre, Brazil, 90610-000
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Porto Alegre, Brazil, 91350-200
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Porto Alegre, Brazil, 9002-060
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Porto Alegre, Brazil, 90110-270
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Porto Alegre, Brazil, 90020-060
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Salvador, Brazil, 41940-455
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Santo Andre, Brazil, 09080-110
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Sao Paulo, Brazil, 04266-010
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Sao Paulo, Brazil, 04020-060
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Sao Paulo, Brazil, 04101-000
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Sorocaba, Brazil, 18040-425
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São Paulo, Brazil, 02189-000
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São Paulo, Brazil, 05403-900
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Blagoevgrad, Bulgaria, 2700
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Pernik, Bulgaria, 2300
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Petrich, Bulgaria, 2850
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Pleven, Bulgaria, 5800
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Razlog, Bulgaria, 2760
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Sliven, Bulgaria, 8800
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Smolyan, Bulgaria, 4700
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Sofia, Bulgaria
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Sofia, Bulgaria, 1431
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Sofia, Bulgaria, 1407
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Sofia, Bulgaria, 1612
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Sofia, Bulgaria, 1404
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Sofia, Bulgaria, 1618
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Sofia, Bulgaria, 1408
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Stara Zagora, Bulgaria, 6000
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Varna, Bulgaria, 9000
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Veliko Tarnovo, Bulgaria, 5000
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Vidin, Bulgaria, 3700
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Yambol, Bulgaria, 8600
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Curico, Chile, 3341643
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Quillota, Chile, 2260000
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Santiago, Chile, 8320000
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Santiago, Chile, 8207257
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Santiago, Chile, 404366
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Talca, Chile, 3465584
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Viña del Mar, Chile, 2520000
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Barranquilla, Colombia, 80001
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Bogota, Colombia, 111511
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Bogotá, Colombia, 110221
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Bogotá, Colombia, 111211
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Medellin, Colombia, 5001000
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Ceska Lipa, Czechia, 470 01
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Kladno, Czechia, 272 00
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Kralupy nad Vltavou, Czechia, 278 01
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Kutna Hora, Czechia, 284 01
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Liberec 1, Czechia, 460 01
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Neratovice, Czechia, 277 01
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Ostrava, Czechia, 728 80
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Ostrava, Czechia, 709 00
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Pardubice, Czechia, 532 03
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Plzen, Czechia, 301 00
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Plzen, Czechia, 304 60
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Praha, Czechia, 169 00
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Praha 4, Czechia, 142 00
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Praha 5, Czechia, 150 00
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Rokycany, Czechia, 337 22
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Rudna U Prahy, Czechia, 252 19
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Tabor, Czechia, 390 01
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Teplice, Czechia, 415 01
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Zatec, Czechia, 43801
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Brii-sous-forges, France, 91640
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Colmar, France, 68000
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Joue-les-Tours, France, 37300
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Nantes Cedex 2, France, 44277
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Nimes, France, 30000
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Reze, France, 44400
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Bad Lippspringe, Germany, 33175
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Berlin, Germany, 10367
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Berlin, Germany, 10119
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Berlin, Germany, 10629
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Berlin, Germany, 10787
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Berlin, Germany, 13507
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Cottbus, Germany, 03050
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Frankfurt/Main, Germany, 60389
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Geesthacht, Germany, 21502
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Großhansdorf, Germany, 22927
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Hamburg, Germany, 20354
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Hannover, Germany, D-30173
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Leipzig, Germany, 04357
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Leipzig, Germany, 04103
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Leipzig, Germany, 04207
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Lübeck, Germany, 23552
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Neu-Isenburg, Germany, 63263
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Oldenburg, Germany, 23758
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Reinfeld, Germany, 23858
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Rüdersdorf, Germany, 15562
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Schleswig, Germany, 24837
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Warendorf, Germany, 48231
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Aszód, Hungary, 2170
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Balassagyarmat, Hungary, 2660
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Berettyóújfalu, Hungary, 4100
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Budapest, Hungary, 1145
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Budapest, Hungary, 1135
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Budapest, Hungary, 1036
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Budapest, Hungary, 1191
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Cegléd, Hungary, 2700
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Gyula, Hungary, 5700
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Gyula, Hungary, 5703
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Gödöllő, Hungary, 2100
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Hajdúnánás, Hungary, 4080
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Létavértes, Hungary, 4281
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Makó, Hungary, 6900
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Miskolc, Hungary, 3529
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Mórahalom, Hungary, 6782
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Pécs, Hungary, 7635
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Siófok, Hungary, 8600
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Szeged, Hungary, H-6722
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Szombathely, Hungary, 9700
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Vásárosnamény, Hungary, 4800
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Érd, Hungary, 2030
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Busan, Korea, Republic of, 49201
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Cheongju-si, Korea, Republic of, 28644
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Daegu, Korea, Republic of, 42415
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Incheon, Korea, Republic of, 405-760
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Seongnam-si, Korea, Republic of, 13620
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Seoul, Korea, Republic of, 05505
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Seoul, Korea, Republic of, 03080
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Seoul, Korea, Republic of, 135-710
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Seoul, Korea, Republic of, 06591
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Seoul, Korea, Republic of, 03312
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Seoul, Korea, Republic of, 04401
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Seoul, Korea, Republic of, 05030
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Suwon-si, Korea, Republic of, 16247
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Uijeongbu-si, Korea, Republic of, 11765
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Wonju-si, Korea, Republic of, 26426
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Chihuahua, Mexico, 31203
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Guadalajara, Mexico, 44670
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Guadalajara, Mexico, 44100
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Mexico City, Mexico, 6726
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Mérida, Mexico, 97070
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México, Mexico, 06720
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San Juan del Rio, Mexico, 76800
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Tlanepantla, Mexico, 54055
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Villahermosa, Mexico, 86035
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Zapopan, Mexico, 45200
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Auckland, New Zealand, 0626
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Christchurch, New Zealand, 8024
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Christchurch, New Zealand, 8041
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Christchurch Central, New Zealand, 8011
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Grafton, New Zealand, 1010
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Hamilton West, New Zealand, 3204
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Maroubra, New Zealand, 2035
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New Lambton, New Zealand, 2310
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Newtown, New Zealand, 6242
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Rotorua, New Zealand, 3010
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South Brisbane, New Zealand, 4101
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Tauranga, New Zealand, 3143
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Wellington, New Zealand, 6021
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Cercado De Lima, Peru, LIMA 1
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Chancay, Peru, 15131
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Lima, Peru, 15033
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Lima, Peru, LIMA 27
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Lima, Peru, LIMA 01
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Lima, Peru, Lima 32
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Lima, Peru, LIMA 21
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Miraflores, Peru, 15046
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Santa Beatriz, Peru, LIMA 14
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Lipa City, Philippines, 4217
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Manila, Philippines
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Pasig City, Philippines, 1600
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Quezon City, Philippines
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Quezon City, Philippines, 1109
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Białystok, Poland, 15-044
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Białystok, Poland, 15-430
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Giżycko, Poland, 11-500
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Kościan, Poland, 64-000
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Kraków, Poland, 31-559
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Lublin, Poland, 20-709
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Mrągowo, Poland, 11-700
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Ostrowiec Świętokrzyski, Poland, 27-400
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Ostrów Wielkopolski, Poland, 63-400
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Pabianice, Poland, 95-200
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Pila, Poland, 64-920
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Poznań, Poland, 60-685
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Poznań, Poland, 60-693
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Proszowice, Poland, 32-100
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Rzeszów, Poland, 35-205
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Warszawa, Poland, 02-106
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Zabrze, Poland, 41-800
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Bragadiru, Romania, 077025
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Brasov, Romania, 500283
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Brasov, Romania, 500051
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Bucharest, Romania, 030303
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Constanta, Romania
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Constanta, Romania, 900002
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Deva, Romania, 330061
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Iasi, Romania, 700115
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Pitesti, Romania, 110084
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Chelyabinsk, Russian Federation, 454021
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Ekaterinburg, Russian Federation, 620137
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Gatchina, Russian Federation, 188300
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Ivanovo, Russian Federation, 153005
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Izhevsk, Russian Federation, 426035
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Kazan, Russian Federation, 420012
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Kemerovo, Russian Federation, 650066
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Kemerovo, Russian Federation, 650000
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Kemerovo, Russian Federation, 650002
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Moscow, Russian Federation, 123182
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Moscow, Russian Federation, 121309
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Moscow, Russian Federation, 109240
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Moscow, Russian Federation, 117630
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Moscow, Russian Federation, 142160
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Novosibirsk, Russian Federation, 630008
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Novosibirsk, Russian Federation, 630051
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Omsk, Russian Federation, 644043
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Penza, Russian Federation, 440067
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Perm, Russian Federation, 614000
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Pskov, Russian Federation, 180007
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Saint - Petersburg, Russian Federation, 196211
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Saint - Petersburg, Russian Federation, 196657
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Saint Petersburg, Russian Federation, 194044
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Saint Petersburg, Russian Federation, 197342
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Saint Petersburg, Russian Federation, 198260
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Saint Petersburg, Russian Federation, 196240
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Saint Petersburg, Russian Federation, 191144
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Saint Petersburg, Russian Federation, 194100
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Saint-Petersburg, Russian Federation, 194291
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Saint-Petersburg, Russian Federation, 198205
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Saint-Petersburg, Russian Federation, 194354
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Saratov, Russian Federation, 410012
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Saratov, Russian Federation, 410053
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St. Petersburg, Russian Federation, 196247
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St. Petersburg, Russian Federation, 197022
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St. Petersburg, Russian Federation, 193231
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St. Petersburg, Russian Federation, 196211
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St.Petersburg, Russian Federation, 194354
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Tomsk, Russian Federation, 634050
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Tver, Russian Federation, 170642
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Ufa, Russian Federation, 450000
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Ulyanovsk, Russian Federation, 432009
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Vladikavkaz, Russian Federation, 362007
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Volgograd, Russian Federation, 400131
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Vsevolozhsk, Russian Federation, 188640
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Yaroslavl, Russian Federation, 150003
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Dhahran, Saudi Arabia, 131932
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Jeddah, Saudi Arabia, 22252
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Jeddah, Saudi Arabia, 21499
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Riyadh, Saudi Arabia, 12371
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Riyadh, Saudi Arabia, 12713
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Kezmarok, Slovakia, 060 01
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Komarno, Slovakia, 945 01
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Kosice, Slovakia, 040 22
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Kosice, Slovakia, 04022
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Levice, Slovakia, 934 01
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Liptovsky Mikulas, Slovakia, 031 01
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Lucenec, Slovakia, 984 01
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Nitra, Slovakia, 94901
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Nove Zamky, Slovakia, 94001
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Poprad, Slovakia, 05801
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Poprad, Slovakia, 058 01
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Rimavska Sobota, Slovakia, 979 01
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Ruzomberok, Slovakia, 034 26
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Skalica, Slovakia, 90901
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Surany, Slovakia, 94201
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Topolcany, Slovakia, 95501
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Trebisov, Slovakia, 07701
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Zilina, Slovakia, 01008
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Zvolen, Slovakia, 96001
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Bellville, South Africa, 7530
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Boksburg North, South Africa, 1460
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Cape Town, South Africa, 7764
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Cape Town, South Africa, 7570
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Durban, South Africa, 4001
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Durban, South Africa, 4091
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Durban, South Africa, 4092
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Durban, South Africa, 4037
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Johannesburg, South Africa, 2188
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Johannesburg, South Africa, 2001
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Lenasia, South Africa, 1829
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Mowbray, South Africa, 7700
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Panorama, South Africa, 7500
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Phoenix, South Africa, 4068
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Verulam, South Africa, 4345
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Alicante, Spain, 03004
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Badalona, Spain, 08916
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Barcelona, Spain, 08036
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Barcelona, Spain, 08025
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Bilbao (Vizcaya), Spain, 48013
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Madrid, Spain, 28046
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Madrid, Spain, 28040
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Malaga, Spain, 29730
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Marbella (Málaga), Spain, 29603
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Oviedo, Spain, 33011
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Sevilla, Spain, 41013
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Sevilla, Spain, 41071
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Terrassa (Barcelona), Spain, 08227
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Valencia, Spain, 46017
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Borås, Sweden, 506 30
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Lund, Sweden, 222 21
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Malmo, Sweden, 21152
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Stockholm, Sweden, 114 46
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Värnamo, Sweden, 33185
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Västra Frölunda, Sweden, 42144
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Bangkok, Thailand, 10330
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Bangkok, Thailand, 10400
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Bangkok, Thailand, 10700
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Bangkok, Thailand, 10600
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Chonburi, Thailand, 20000
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Hat Yai, Thailand, 90110
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Khon Kaen, Thailand, 40002
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Muang,, Thailand, 55000
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Nonthaburi, Thailand, 11000
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Pathumthani, Thailand, 12120
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Cherkasy, Ukraine, 18009
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Chernihiv, Ukraine, 14034
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Chernivtsi, Ukraine, 58000
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Dnipro, Ukraine, 49074
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Ivano-Frankivsk, Ukraine, 76018
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Ivano-Frankivsk, Ukraine, 76012
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Kharkiv, Ukraine, 61039
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Kharkiv, Ukraine, 61058
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Kharkiv, Ukraine, 61075
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Kharkiv, Ukraine, 61035
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Kherson, Ukraine, 73000
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Kyiv, Ukraine, 04050
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Kyiv, Ukraine, 02091
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Kyiv, Ukraine, 03037
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Kyiv, Ukraine, 03680
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Lutsk, Ukraine, 43000
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Lviv, Ukraine, 79066
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Odesa, Ukraine, 65025
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Odessa, Ukraine, 65114
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Ternopil, Ukraine, 46000
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Uzhgorod, Ukraine, 88000
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Uzhgorod, Ukraine, 88014
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Uzhgorod, Ukraine, 88009
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Vinnytsia, Ukraine, 21001
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Zaporizhzhya, Ukraine, 69068
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Zaporizhzhya, Ukraine, 69063
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Can Tho, Vietnam, 900000
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Ha Noi, Vietnam, 100000
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Hanoi, Vietnam, 100000
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Ho Chi Minh, Vietnam, 700000
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Hochiminh, Vietnam, 700000
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Hue, Vietnam, 530000
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 130 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Provision of informed consent prior to any study specific procedures. For patients under-age, signed informed consent from both the patient and the patient's parent/legal guardian is required
- Male or Female, ≥12 years of age
- Documented diagnosis of asthma for at least 6 months prior to Visit 1
- Patients who are in need of GINA step 2 treatment
- 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
- 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
- Patients should have reversible airway obstruction
- 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:
- Patient has a history of life-threatening asthma including intubation and intensive care unit admission
- 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
- 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
- Current or previous smoker with a smoking history of ≥ 10 pack years
- Pregnancy, breast-feeding or planned pregnancy during the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Symbicort "as needed"+placebo Pulmicort bid
Symbicort (budesonide/formoterol) Turbuhaler 160/4.5 μg 'as needed' + Placebo Pulmicort Turbuhaler 200 μg bid
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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
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Active Comparator: Pulmicort bid + terbutaline "as needed"
Pulmicort 200 μg Turbuhaler bid + terbutaline 0.4 mg Turbuhaler 'as needed'
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Annual Severe Asthma Exacerbation Rate - Non-inferiority Analysis
Time Frame: up to 52 weeks
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Severe asthma exacerbations over the randomised treatment period, negative binomial model for non-inferiority test evaluation
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up to 52 weeks
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Annual Severe Asthma Exacerbation Rate - Superiority Analysis
Time Frame: up to 52 weeks
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Severe asthma exacerbations over the randomised treatment period, negative binomial model for superiority test evaluation
|
up to 52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Experiencing at Least One Severe Asthma Exacerbation
Time Frame: Day 1 up to 52 weeks
|
A severe exacerbation is defined as a deterioration of asthma requiring any of the following: use of systemic glucocorticosteroids (GCS) for at least 3 days, inpatient hospitalization, or emergency room visit due to asthma that required systemic steroids.
|
Day 1 up to 52 weeks
|
|
Average Change From Baseline in Pre-bronchodilator FEV1
Time Frame: Study weeks 0,17, 34, 52
|
The average change from baseline (baseline defined by measurement at week 0, prior to first dose of IP) to the treatment period average assessed over the entire treatment period in pre-bronchodilator FEV1 was derived by computing a contrast for the mean across the post-randomisation visits (week 17, 34, 52) from the MMRM (mixed model repeated measures) analysis.
|
Study weeks 0,17, 34, 52
|
|
Number of Participants With Study Specific Asthma Related Discontinuation
Time Frame: Day 1 up to 52 weeks
|
The following two criteria lead to discontinuation from the IP due to asthma related events: A severe asthma exacerbation with duration for more than 3 weeks, and/or three severe asthma exacerbations during 6 months.
|
Day 1 up to 52 weeks
|
|
Average Change From Baseline in 'as Needed' Use
Time Frame: Week 0 up to 52 weeks
|
'As-needed' use change from baseline over the randomised treatment period.
Baseline was defined as the last 10 days of the run-in period.
'As needed' use was calculated as the cumulative doses of 'as-needed' medication over the randomised treatment period divided by the follow-up time (number of days - 1). ie, average number of inhalations per day.
|
Week 0 up to 52 weeks
|
|
Change From Baseline in Percent of 'as Needed' Free Days
Time Frame: Week 0 up to 52 weeks
|
'As needed' free days (%) change from baseline during randomised treatment period.
An 'as-needed' free day was defined as a day and night with no use of 'as needed' medication.
Variable analysed is the percentage (%) of 'as-needed' free days during the randomised treatment period.
Baseline is defined by the last 10 days of the run-in period.
|
Week 0 up to 52 weeks
|
|
Percentage of Controller Use Days
Time Frame: Week 0 up to 52 weeks
|
ICS controller use days (%) during the randomised treatment period is calculated as the cumulative days when any controller medication (containing ICS) was taken including maintenance (Pulmicort bid group) and 'as needed' medication (Symbicort 'as needed' group) and additional prescribed ICS for asthma (all treatment groups), divided by the number of days in the randomised treatment period.
|
Week 0 up to 52 weeks
|
|
Average Change From Baseline in Asthma Control Questionnaire (5-item Version) - ACQ-5 Score
Time Frame: Study weeks 0, 17, 34, 52
|
ACQ questionnaire contains five questions on patients' symptoms, which are assessed on a 7-point scale from 0 (representing good control) to 6 (representing poor control).
The score is the mean score of all questions for which responses are provided.
The average change from baseline to treatment period average in ACQ-5 was derived by computing a contrast for the mean across all post-randomisation visits (week 17, 34, 52) from the MMRM (mixed model repeated measures) analysis.
|
Study weeks 0, 17, 34, 52
|
|
Average Change From Baseline in Asthma Quality of Life Questionnaire Standardised Version - AQLQ(S) Score
Time Frame: Study weeks 0,17, 34, 52
|
AQLQ(S) consists of 32 questions in 4 domains.
Each question is assessed on a 7-point scale from 1 to 7, with higher values indicating better health-related quality of life.
The overall score is calculated as the mean score of all 32 items.
The average change from baseline to treatment period average in AQLQ(S) overall score was derived by computing a contrast for the mean across all post-randomisation visits (week 17, 34, 52) from the MMRM (mixed model repeated measures) analysis.
|
Study weeks 0,17, 34, 52
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Carin Jorup, MD, AstraZeneca Research & Development
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 28, 2014
Primary Completion (Actual)
August 16, 2017
Study Completion (Actual)
August 16, 2017
Study Registration Dates
First Submitted
August 19, 2014
First Submitted That Met QC Criteria
August 22, 2014
First Posted (Estimate)
August 25, 2014
Study Record Updates
Last Update Posted (Actual)
November 25, 2019
Last Update Submitted That Met QC Criteria
November 6, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
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
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Reproductive Control Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Tocolytic Agents
- Sympathomimetics
- Budesonide
- Formoterol Fumarate
- Terbutaline
Other Study ID Numbers
- D589SC00003
- 2013-004473-28 (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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