A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma
SYGMA2
A Clinical Study Comparing Symbicort 'as Needed' With Pulmicort Twice Daily Plus Terbutaline 'as Needed' in Adult and Adolescent Patients With Asthma
2 other identifiers
interventional
4,215
25 countries
340
Brief Summary
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'
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 asthma
Started Nov 2014
Typical duration for phase_3 asthma
340 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2014
CompletedFirst Posted
Study publicly available on registry
August 25, 2014
CompletedStudy Start
First participant enrolled
November 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 16, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 16, 2017
CompletedResults Posted
Study results publicly available
November 25, 2019
CompletedNovember 25, 2019
November 1, 2019
2.7 years
August 19, 2014
August 16, 2018
November 6, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Annual Severe Asthma Exacerbation Rate - Non-inferiority Analysis
Severe asthma exacerbations over the randomised treatment period, negative binomial model for non-inferiority test evaluation
up to 52 weeks
Annual Severe Asthma Exacerbation Rate - Superiority Analysis
Severe asthma exacerbations over the randomised treatment period, negative binomial model for superiority test evaluation
up to 52 weeks
Secondary Outcomes (8)
Number of Participants Experiencing at Least One Severe Asthma Exacerbation
Day 1 up to 52 weeks
Average Change From Baseline in Pre-bronchodilator FEV1
Study weeks 0,17, 34, 52
Number of Participants With Study Specific Asthma Related Discontinuation
Day 1 up to 52 weeks
Average Change From Baseline in 'as Needed' Use
Week 0 up to 52 weeks
Change From Baseline in Percent of 'as Needed' Free Days
Week 0 up to 52 weeks
- +3 more secondary outcomes
Study Arms (2)
Symbicort "as needed"+placebo Pulmicort bid
EXPERIMENTALSymbicort (budesonide/formoterol) Turbuhaler 160/4.5 μg 'as needed' + Placebo Pulmicort Turbuhaler 200 μg bid
Pulmicort bid + terbutaline "as needed"
ACTIVE COMPARATORPulmicort 200 μg Turbuhaler bid + terbutaline 0.4 mg Turbuhaler 'as needed'
Interventions
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 (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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (340)
Research Site
Sydney, 2010, Australia
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Botucatu, 18618-970, Brazil
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Florianópolis, 88040-970, Brazil
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Goiânia, 74110 030, Brazil
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Porto Alegre, 9002-060, Brazil
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Porto Alegre, 90020-060, Brazil
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Porto Alegre, 90110-270, Brazil
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Porto Alegre, 90610-000, Brazil
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Porto Alegre, 91350-200, Brazil
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Salvador, 41940-455, Brazil
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Santo André, 09080-110, Brazil
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São Paulo, 02189-000, Brazil
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São Paulo, 04020-060, Brazil
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São Paulo, 04101-000, Brazil
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São Paulo, 04266-010, Brazil
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São Paulo, 05403-900, Brazil
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Sorocaba, 18040-425, Brazil
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Blagoevgrad, 2700, Bulgaria
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Pernik, 2300, Bulgaria
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Petrich, 2850, Bulgaria
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Pleven, 5800, Bulgaria
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Razlog, 2760, Bulgaria
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Sliven, 8800, Bulgaria
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Smolyan, 4700, Bulgaria
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Sofia, 1404, Bulgaria
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Sofia, 1407, Bulgaria
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Sofia, 1408, Bulgaria
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Sofia, 1431, Bulgaria
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Sofia, 1612, Bulgaria
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Sofia, 1618, Bulgaria
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Sofia, Bulgaria
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Stara Zagora, 6000, Bulgaria
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Varna, 9000, Bulgaria
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Veliko Tarnovo, 5000, Bulgaria
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Vidin, 3700, Bulgaria
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Yambol, 8600, Bulgaria
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Curicó, 3341643, Chile
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Quillota, 2260000, Chile
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Santiago, 404366, Chile
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Santiago, 8207257, Chile
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Santiago, 8320000, Chile
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Talca, 3465584, Chile
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Viña del Mar, 2520000, Chile
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Barranquilla, 80001, Colombia
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Bogotá, 110221, Colombia
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Bogotá, 111211, Colombia
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Bogotá, 111511, Colombia
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Medellín, 5001000, Colombia
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Česká Lípa, 470 01, Czechia
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Kladno, 272 00, Czechia
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Kralupy nad Vltavou, 278 01, Czechia
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Kutná Hora, 284 01, Czechia
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Liberec, 460 01, Czechia
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Neratovice, 277 01, Czechia
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Ostrava, 709 00, Czechia
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Ostrava, 728 80, Czechia
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Pardubice, 532 03, Czechia
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Pilsen, 301 00, Czechia
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Pilsen, 304 60, Czechia
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Prague, 142 00, Czechia
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Prague, 150 00, Czechia
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Prague, 169 00, Czechia
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Rokycany, 337 22, Czechia
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Rudna U Prahy, 252 19, Czechia
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Tábor, 390 01, Czechia
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Teplice, 415 01, Czechia
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Žatec, 43801, Czechia
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Brii-sous-forges, 91640, France
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Colmar, 68000, France
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Joué-lès-Tours, 37300, France
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Nantes, 44277, France
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Nîmes, 30000, France
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Rezé, 44400, France
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Bad Lippspringe, 33175, Germany
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Berlin, 10119, Germany
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Berlin, 10367, Germany
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Berlin, 10629, Germany
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Berlin, 10787, Germany
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Berlin, 13507, Germany
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Cottbus, 03050, Germany
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Frankfurt am Main, 60389, Germany
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Geesthacht, 21502, Germany
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Großhansdorf, 22927, Germany
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Hamburg, 20354, Germany
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Hanover, D-30173, Germany
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Leipzig, 04103, Germany
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Leipzig, 04207, Germany
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Leipzig, 04357, Germany
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Lübeck, 23552, Germany
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Neu-Isenburg, 63263, Germany
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Oldenburg, 23758, Germany
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Reinfeld, 23858, Germany
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Rüdersdorf, 15562, Germany
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Schleswig, 24837, Germany
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Warendorf, 48231, Germany
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Aszód, 2170, Hungary
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Balassagyarmat, 2660, Hungary
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Berettyóújfalu, 4100, Hungary
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Budapest, 1036, Hungary
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Budapest, 1135, Hungary
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Budapest, 1145, Hungary
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Budapest, 1191, Hungary
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Cegléd, 2700, Hungary
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Érd, 2030, Hungary
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Gödöllő, 2100, Hungary
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Gyula, 5700, Hungary
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Gyula, 5703, Hungary
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Hajdúnánás, 4080, Hungary
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Létavértes, 4281, Hungary
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Makó, 6900, Hungary
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Miskolc, 3529, Hungary
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Mórahalom, 6782, Hungary
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Pécs, 7635, Hungary
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Siófok, 8600, Hungary
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Szeged, H-6722, Hungary
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Szombathely, 9700, Hungary
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Vásárosnamény, 4800, Hungary
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Chihuahua City, 31203, Mexico
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Guadalajara, 44100, Mexico
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Guadalajara, 44670, Mexico
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Mexico City, 6726, Mexico
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Mérida, 97070, Mexico
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México, 06720, Mexico
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San Juan del Río, 76800, Mexico
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Tlanepantla, 54055, Mexico
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Villahermosa, 86035, Mexico
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Zapopan, 45200, Mexico
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Auckland, 0626, New Zealand
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Christchurch, 8024, New Zealand
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Christchurch, 8041, New Zealand
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Christchurch Central, 8011, New Zealand
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Grafton, 1010, New Zealand
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Hamilton West, 3204, New Zealand
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Maroubra, 2035, New Zealand
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New Lambton, 2310, New Zealand
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Newtown, 6242, New Zealand
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Rotorua, 3010, New Zealand
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South Brisbane, 4101, New Zealand
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Tauranga, 3143, New Zealand
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Wellington, 6021, New Zealand
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Chancay, 15131, Peru
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Lima, 15033, Peru
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Lima, LIMA 01, Peru
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Lima, LIMA 21, Peru
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Lima, LIMA 27, Peru
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Lima, LIMA 32, Peru
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Lima Cercado, LIMA 1, Peru
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Miraflores, 15046, Peru
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Santa Beatriz, LIMA 14, Peru
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Lipa City, 4217, Philippines
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Manila, Philippines
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Pasig, 1600, Philippines
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Quezon City, 1109, Philippines
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Quezon City, Philippines
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Bialystok, 15-044, Poland
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Bialystok, 15-430, Poland
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Giżycko, 11-500, Poland
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Kościan, 64-000, Poland
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Krakow, 31-559, Poland
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Lublin, 20-709, Poland
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Mrągowo, 11-700, Poland
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Ostrowiec Świętokrzyski, 27-400, Poland
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Ostrów Wielkopolski, 63-400, Poland
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Pabianice, 95-200, Poland
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Piła, 64-920, Poland
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Poznan, 60-685, Poland
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Poznan, 60-693, Poland
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Proszowice, 32-100, Poland
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Rzeszów, 35-205, Poland
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Warsaw, 02-106, Poland
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Zabrze, 41-800, Poland
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Bragadiru, 077025, Romania
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Brasov, 500051, Romania
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Brasov, 500283, Romania
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Bucharest, 030303, Romania
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Constanța, 900002, Romania
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Constanța, Romania
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Deva, 330061, Romania
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Iași, 700115, Romania
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Piteşti, 110084, Romania
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Chelyabinsk, 454021, Russia
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Gatchina, 188300, Russia
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Ivanovo, 153005, Russia
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Izhevsk, 426035, Russia
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Kazan', 420012, Russia
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Kemerovo, 650000, Russia
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Kemerovo, 650002, Russia
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Kemerovo, 650066, Russia
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Moscow, 109240, Russia
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Moscow, 117630, Russia
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Moscow, 121309, Russia
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Moscow, 123182, Russia
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Moscow, 142160, Russia
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Novosibirsk, 630008, Russia
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Novosibirsk, 630051, Russia
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Omsk, 644043, Russia
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Penza, 440067, Russia
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Perm, 614000, Russia
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Pskov, 180007, Russia
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Saint Petersburg, 191144, Russia
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Saint Petersburg, 193231, Russia
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Saint Petersburg, 194044, Russia
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Saint Petersburg, 194100, Russia
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Saint Petersburg, 194291, Russia
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Saint Petersburg, 194354, Russia
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Saint Petersburg, 196211, Russia
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Saint Petersburg, 196240, Russia
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Saint Petersburg, 196247, Russia
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Saint Petersburg, 196657, Russia
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Saint Petersburg, 197022, Russia
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Saint Petersburg, 197342, Russia
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Saint Petersburg, 198205, Russia
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Saint Petersburg, 198260, Russia
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Saratov, 410012, Russia
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Saratov, 410053, Russia
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Tomsk, 634050, Russia
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Tver', 170642, Russia
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Ufa, 450000, Russia
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Ulyanovsk, 432009, Russia
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Vladikavkaz, 362007, Russia
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Volgograd, 400131, Russia
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Vsevolozhsk, 188640, Russia
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Yaroslavl, 150003, Russia
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Yekaterinburg, 620137, Russia
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Dhahran, 131932, Saudi Arabia
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Jeddah, 21499, Saudi Arabia
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Jeddah, 22252, Saudi Arabia
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Riyadh, 12371, Saudi Arabia
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Riyadh, 12713, Saudi Arabia
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Kežmarok, 060 01, Slovakia
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Komárno, 945 01, Slovakia
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Košice, 040 22, Slovakia
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Košice, 04022, Slovakia
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Levice, 934 01, Slovakia
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Liptovský Mikuláš, 031 01, Slovakia
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Lučenec, 984 01, Slovakia
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Nitra, 94901, Slovakia
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Nové Zámky, 94001, Slovakia
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Poprad, 058 01, Slovakia
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Poprad, 05801, Slovakia
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Rimavská Sobota, 979 01, Slovakia
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Ružomberok, 034 26, Slovakia
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Skalica, 90901, Slovakia
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Šurany, 94201, Slovakia
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Topoľčany, 95501, Slovakia
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Trebišov, 07701, Slovakia
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Zvolen, 96001, Slovakia
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Žilina, 01008, Slovakia
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Bellville, 7530, South Africa
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Boksburg North, 1460, South Africa
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Cape Town, 7570, South Africa
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Cape Town, 7764, South Africa
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Durban, 4001, South Africa
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Durban, 4037, South Africa
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Durban, 4091, South Africa
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Durban, 4092, South Africa
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Johannesburg, 2001, South Africa
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Johannesburg, 2188, South Africa
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Lenasia, 1829, South Africa
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Mowbray, 7700, South Africa
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Panorama, 7500, South Africa
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Phoenix, 4068, South Africa
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Verulam, 4345, South Africa
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Busan, 49201, South Korea
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Cheongju-si, 28644, South Korea
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Daegu, 42415, South Korea
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Incheon, 405-760, South Korea
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Seongnam-si, 13620, South Korea
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Seoul, 03080, South Korea
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Seoul, 03312, South Korea
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Seoul, 04401, South Korea
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Seoul, 05030, South Korea
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Seoul, 05505, South Korea
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Seoul, 06591, South Korea
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Seoul, 135-710, South Korea
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Suwon, 16247, South Korea
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Uijeongbu-si, 11765, South Korea
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Wŏnju, 26426, South Korea
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Alicante, 03004, Spain
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Badalona, 08916, Spain
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Barcelona, 08025, Spain
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Barcelona, 08036, Spain
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Bilbao (Vizcaya), 48013, Spain
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Madrid, 28040, Spain
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Madrid, 28046, Spain
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Marbella (Málaga), 29603, Spain
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Málaga, 29730, Spain
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Oviedo, 33011, Spain
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Seville, 41013, Spain
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Seville, 41071, Spain
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Terrassa (Barcelona), 08227, Spain
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Valencia, 46017, Spain
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Borås, 506 30, Sweden
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Lund, 222 21, Sweden
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Malmo, 21152, Sweden
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Stockholm, 114 46, Sweden
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Värnamo, 33185, Sweden
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Västra Frölunda, 42144, Sweden
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Bangkok, 10330, Thailand
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Bangkok, 10400, Thailand
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Bangkok, 10600, Thailand
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Bangkok, 10700, Thailand
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Chon Buri, 20000, Thailand
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Hat Yai, 90110, Thailand
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Khon Kaen, 40002, Thailand
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Muang,, 55000, Thailand
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Nonthaburi, 11000, Thailand
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Pathum Thani, 12120, Thailand
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Cherkasy, 18009, Ukraine
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Chernihiv, 14034, Ukraine
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Chernivtsi, 58000, Ukraine
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Dnipro, 49074, Ukraine
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Ivano-Frankivsk, 76012, Ukraine
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Ivano-Frankivsk, 76018, Ukraine
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Kharkiv, 61035, Ukraine
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Kharkiv, 61039, Ukraine
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Kharkiv, 61058, Ukraine
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Kharkiv, 61075, Ukraine
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Kherson, 73000, Ukraine
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Kyiv, 02091, Ukraine
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Kyiv, 03037, Ukraine
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Kyiv, 03680, Ukraine
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Kyiv, 04050, Ukraine
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Lutsk, 43000, Ukraine
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Lviv, 79066, Ukraine
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Odesa, 65025, Ukraine
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Odesa, 65114, Ukraine
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Ternopil, 46000, Ukraine
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Uzhhorod, 88000, Ukraine
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Uzhhorod, 88009, Ukraine
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Uzhhorod, 88014, Ukraine
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Vinnytsia, 21001, Ukraine
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Zaporizhzhya, 69063, Ukraine
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Zaporizhzhya, 69068, Ukraine
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Can Tho, 900000, Vietnam
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Hanoi, 100000, Vietnam
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Hà Nội, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Hochiminh, 700000, Vietnam
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Huế, 530000, Vietnam
Related Publications (4)
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.
PMID: 33548020DERIVEDBateman 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.
PMID: 29768147DERIVEDO'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.
PMID: 28069068DERIVEDReddel 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.
PMID: 27912982DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Stefan Ivanov
- Organization
- AstraZeneca AB
Study Officials
- STUDY DIRECTOR
Carin Jorup, MD
AstraZeneca Research & Development
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2014
First Posted
August 25, 2014
Study Start
November 28, 2014
Primary Completion
August 16, 2017
Study Completion
August 16, 2017
Last Updated
November 25, 2019
Results First Posted
November 25, 2019
Record last verified: 2019-11