A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma.
SYGMA1
A Clinical Study Comparing Symbicort® 'as Needed' With Terbutaline 'as Needed' and With Pulmicort® Twice Daily Plus Terbutaline 'as Needed' in Adult and Adolescent Patients With Asthma.
2 other identifiers
interventional
3,850
18 countries
255
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: 1) terbutaline Turbuhaler® 'as needed' and with 2) 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 Jul 2014
Longer than P75 for phase_3 asthma
255 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
May 16, 2014
CompletedFirst Posted
Study publicly available on registry
May 29, 2014
CompletedStudy Start
First participant enrolled
July 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 2, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 2, 2017
CompletedResults Posted
Study results publicly available
September 13, 2019
CompletedNovember 15, 2019
November 1, 2019
3.1 years
May 16, 2014
August 2, 2018
November 4, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
'Well-controlled Asthma Week' - a Derived Binary Variable (Yes/No)
A well-controlled asthma week is defined as the fulfilment of both conditions A) and B) below: A) Two or more of the following criteria are fulfilled: - No more than 2 days with a daily asthma symptom score \>1 - No more than 2 days of 'as needed' medication use, up to a maximum of 4 occasions per week (multiple occasions per day should be regarded as separate occasions) - Morning PEF ≥80% of Predicted Normal every day B) Both of the following criteria are fulfilled: - No nighttime awakenings due to asthma - No additional inhaled and/or systemic glucocorticosteroid treatment due to asthma. The binary variable well-controlled asthma week was derived for each patient and study week. In addition, for each week, the percent of patients with well-controlled asthma week was derived. It is required that the eDiary had to be completed on at least 5 days in a week to be a well-controlled asthma week.
Weekly, up to 52 weeks
Secondary Outcomes (19)
Number of Participants Experiencing at Least One Severe Asthma Exacerbation
Day 1 up to 52 weeks
Number of Participants Experiencing at Least One Moderate or Severe Asthma Exacerbation
Day 1 up to 52 weeks
Average Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1)
Study weeks 0,4,16,28,40,52
Average Change From Baseline in Morning Peak Expiratory Flow (PEF)
up to 52 weeks
Average Change From Baseline in Evening PEF
up to 52 weeks
- +14 more secondary outcomes
Study Arms (3)
Symbicort "as needed"+placebo Pulmicort bid
EXPERIMENTALSymbicort (budesonide/formoterol) Turbuhaler 160/4.5 μg 'as needed' + Placebo Pulmicort Turbuhaler 200 μg bid
terbutaline "as needed"+placebo Pulmicort bid
ACTIVE COMPARATORterbutaline Turbuhaler 0.4 mg 'as needed' + placebo Pulmicort 200 μg Turbuhaler 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
Terbutaline 0.4 mg powder for inhalation 'as needed' plus placebo Pulmicort (budesonide) 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening), 52-week treatment
Pulmicort (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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (255)
Research Site
Bedford Park, 5042, Australia
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Concord, 2139, Australia
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Maroubra, 2035, Australia
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Murdoch, 6150, Australia
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Wollongong, 2522, Australia
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Alphaville, 06454-010, Brazil
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Botucatu, 18618-970, Brazil
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Porto Alegre, 90020-060, Brazil
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Porto Alegre, 90470-340, Brazil
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Porto Alegre, 90610-000, Brazil
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Salvador, 41940-455, Brazil
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Santo André, 09080-110, Brazil
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São Paulo, 04020-060, Brazil
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São Paulo, 04101-000, Brazil
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Sorocaba, 18040-425, Brazil
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Dupnitsa, 2600, Bulgaria
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Gotse Delchev, 2900, Bulgaria
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Kozloduy, 3320, Bulgaria
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Pazardzhik, 4400, Bulgaria
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Plovdiv, 4002, Bulgaria
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Razgrad, 7200, Bulgaria
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Roman, 3130, Bulgaria
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Rousse, 7002, Bulgaria
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Sandanski, 2800, Bulgaria
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Sofia, 1000, Bulgaria
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Sofia, 1152, Bulgaria
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Sofia, 1431, Bulgaria
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Sofia, 1606, Bulgaria
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Sofia, 1618, Bulgaria
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Varna, 9000, Bulgaria
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Velingrad, 4600, Bulgaria
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Vratsa, 3000, Bulgaria
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Edmonton, Alberta, T5A 4L8, Canada
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Sherwood Park, Alberta, T8L 0N2, Canada
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Maple Ridge, British Columbia, V2X 2L5, Canada
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North Vancouver, British Columbia, V7M 2H9, Canada
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Vancouver, British Columbia, V5Z 1M9, Canada
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Mount Pearl, Newfoundland and Labrador, A1N 1W7, Canada
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St. John's, Newfoundland and Labrador, A1A 3R5, Canada
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Ajax, Ontario, L1S 2J5, Canada
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Burlington, Ontario, L7N 3V2, Canada
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Cornwall, Ontario, K6H 4M4, Canada
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Etobicoke, Ontario, M9W 4L6, Canada
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Hamilton, Ontario, L8N 4A6, Canada
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Kanata, Ontario, K2L 3C8, Canada
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London, Ontario, N6H 0G6, Canada
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Mississauga, Ontario, L5A 3V4, Canada
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Newmarket, Ontario, L3Y 5G8, Canada
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North York, Ontario, M3M 3E5, Canada
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Ottawa, Ontario, K2H 8T5, Canada
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Sarnia, Ontario, N7T 4X3, Canada
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Toronto, Ontario, M9C 4Z5, Canada
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Toronto, Ontario, M9V 4B4, Canada
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Windsor, Ontario, N8X 2G1, Canada
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Lévis, Quebec, G6W 0M5, Canada
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Montreal, Quebec, H1M 1B1, Canada
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Montreal, Quebec, H3G 1L5, Canada
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Montreal, Quebec, H4J 1C5, Canada
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Pointe-Claire, Quebec, H9R 4S3, Canada
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Québec, Quebec, G1G 3Y8, Canada
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Québec, Quebec, G1V 4W2, Canada
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Québec, Quebec, G1W 4R4, Canada
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Québec, Quebec, G2J 0C4, Canada
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Saint-Charles-Borromée, Quebec, J6E 2B4, Canada
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Trois-Rivières, Quebec, G8T 7A1, Canada
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Victoriaville, Quebec, G6P 6P6, Canada
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Quillota, 2260000, Chile
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Santiago, 404366, Chile
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Santiago, 7750495, Chile
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Santiago, 7980378, Chile
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Santiago, 8380453, Chile
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Talcahuano, 4270918, Chile
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Beijing, 100043, China
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Beijing, 100050, China
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Changsha, 430033, China
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Chengdu, 610041, China
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Chengdu, 610083, China
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Guangzhou, 510120, China
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Guangzhou, 510515, China
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Haikou, 570311, China
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Hohhot, 010017, China
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Nanchang, 330006, China
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Shanghai, 200000, China
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Shanghai, 200032, China
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Shanghai, 200040, China
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Shanghai, 200120, China
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Shanghai, 200240, China
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Shanghai, 200433, China
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Shenyang, 110015, China
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Wenzhou, 325027, China
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Wuhan, CN-430030, China
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Xi'an, 710004, China
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Xi'an, 710038, China
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Xiamen, 361004, China
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Xuzhou, 221006, China
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Balassagyarmat, 2660, Hungary
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Berettyóújfalu, 4100, Hungary
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Budapest, 1195, Hungary
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Budapest, 1204, Hungary
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Edelény, 3780, Hungary
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Hajdúnánás, 4080, Hungary
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Mátészalka, 4700, Hungary
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Miskolc, 3529, Hungary
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Monor, 2200, Hungary
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Nyírbátor, 4300, Hungary
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Nyíregyháza, 4420, Hungary
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Pécs, 7626, Hungary
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Pécs, 7635, Hungary
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Szeged, H-6722, Hungary
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D.F., 03020, Mexico
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Durango, 43080, Mexico
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México, 04530, Mexico
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México, 06700, Mexico
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México, 06720, Mexico
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Monterrey, 64461, Mexico
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Morelia, 58070, Mexico
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Villahermosa, 86035, Mexico
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Cusco, CUSCO 01, Peru
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Lima, 41, Peru
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Lima, L18, Peru
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Lima, L27, Peru
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Lima, LIMA 1, Peru
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Lima, LIMA 31, Peru
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Lima, LIMA 41, Peru
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Piura, Peru
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Surco, LIMA 33, Peru
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Lipa City, 4217, Philippines
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Manila, 1000, Philippines
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Manila, 1003, Philippines
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Pasig, 1000, Philippines
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Quezon City, 1101, Philippines
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Bialystok, 15-003, Poland
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Bialystok, 15-430, Poland
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Elblag, 82-300, Poland
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Grodzisk Mazowiecki, 05-825, Poland
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Grudziądz, 86-300, Poland
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Kielce, 25-734, Poland
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Krakow, 30-901, Poland
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Krakow, 31-011, Poland
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Krakow, 31-209, Poland
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Krakow, 31-455, Poland
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Lodz, 90-141, Poland
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Lodz, 90-203, Poland
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Lodz, 91-103, Poland
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Poznan, 60-685, Poland
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Poznan, 60-823, Poland
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Rzeszów, 35-051, Poland
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Rzeszów, 35-612, Poland
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Skierniewice, 96-100, Poland
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Strzelce Opolskie, 47-100, Poland
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Szczecin, 70-111, Poland
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Szczecin, 71-124, Poland
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Słupca, 62-400, Poland
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Tarnów, 33-100, Poland
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Trzebnica, 55-100, Poland
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Turek, 62-700, 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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Cluj-Napoca, 400371, Romania
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Constanța, 900002, Romania
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Piteşti, 110084, Romania
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Timișoara, 300310, 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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Kazan', 420012, Russia
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Kemerovo, 650002, Russia
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Kemerovo, 650099, Russia
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Krasnoyarsk, 660022, Russia
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Moscow, 105077, Russia
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Moscow, 109240, Russia
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Moscow, 117630, Russia
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Moscow, 119992, Russia
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Moscow, 123995, Russia
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Moscow, 127018, Russia
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Moscow, 142160, Russia
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Nizhny Novgorod, 603126, Russia
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Novosibirsk, 630008, Russia
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Novosibirsk, 630084, Russia
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Penza, 440067, Russia
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Perm, 614056, Russia
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Perm, 6144090, Russia
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Petrozavodsk, 185019, Russia
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Pyatigorsk, 357538, Russia
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Ryazan, 390026, Russia
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Saint Petersburg, 193312, Russia
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Saint Petersburg, 194100, Russia
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Saint Petersburg, 194354, Russia
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Saint Petersburg, 196084, Russia
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Saint Petersburg, 196211, Russia
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Saint Petersburg, 196657, Russia
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Saint Petersburg, 197022, Russia
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Saratov, 410012, Russia
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Ulyanovsk, 432009, Russia
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Vladikavkaz, 362007, Russia
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Volgograd, 400001, Russia
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Volgograd, 400131, Russia
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Voronezh, 394066, Russia
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Yaroslavl, 150002, Russia
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Yaroslavl, 150003, Russia
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Yekaterinburg, 620039, Russia
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Yekaterinburg, 620109, Russia
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Yekaterinburg, 620219, Russia
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Boksburg North, 1460, South Africa
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Durban, 4001, South Africa
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Durban, 4037, South Africa
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Durban, 4170, South Africa
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Johannesburg, 1818, South Africa
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Johannesburg, 2001, South Africa
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KwaDukuza, 4450, South Africa
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Middelburg, 1055, South Africa
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Queenswood, South Africa
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Verulam, 4345, South Africa
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Bucheon-si, 14584, South Korea
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Cheongju-si, 28644, South Korea
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Cheongju-si, 362-804, South Korea
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Incheon, 21431, South Korea
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Seoul, 03181, South Korea
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Seoul, 03312, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06591, South Korea
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Seoul, 07985, South Korea
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Seoul, 110-744, South Korea
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Cherkasy, 18009, Ukraine
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Dnipropetrovsk, 49074, Ukraine
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Ivano-Frankivsk, 76012, Ukraine
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Kharkiv, 61002, 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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Kharkiv, 61093, Ukraine
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Kyiv, 03049, Ukraine
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Kyiv, 03680, Ukraine
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Kyiv, Ukraine
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Lutsk, 43000, Ukraine
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Lutsk, 43024, Ukraine
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Lviv, 79066, Ukraine
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Odesa, 65025, Ukraine
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Vinnytsia, 21018, Ukraine
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Zaporizhzhya, 69068, Ukraine
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Bath, BA3 2UH, United Kingdom
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Coventry, CV6 4DD, United Kingdom
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Mortimer Reading, RG7 3SQ, United Kingdom
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Royal Leamington Spa, CV32 4RA, United Kingdom
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Trowbridge, BA14 8QA, United Kingdom
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Haiphong, 180000, Vietnam
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Hanoi, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Ho Chi Minh City, Vietnam
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Hochiminh, Vietnam
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Đông Nãi, 810000, Vietnam
Related Publications (5)
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: 33548020DERIVEDO'Byrne PM, FitzGerald JM, Bateman ED, Barnes PJ, Zheng J, Gustafson P, Lamarca R, Puu M, Keen C, Alagappan VKT, Reddel HK. Effect of a single day of increased as-needed budesonide-formoterol use on short-term risk of severe exacerbations in patients with mild asthma: a post-hoc analysis of the SYGMA 1 study. Lancet Respir Med. 2021 Feb;9(2):149-158. doi: 10.1016/S2213-2600(20)30416-1. Epub 2020 Oct 1.
PMID: 33010810DERIVEDO'Byrne PM, FitzGerald JM, Bateman ED, Barnes PJ, Zhong N, Keen C, Jorup C, Lamarca R, Ivanov S, Reddel HK. Inhaled Combined Budesonide-Formoterol as Needed in Mild Asthma. N Engl J Med. 2018 May 17;378(20):1865-1876. doi: 10.1056/NEJMoa1715274.
PMID: 29768149DERIVEDO'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
- PRINCIPAL INVESTIGATOR
Paul M O'Byrne, MB, FRCP(C), FRSC
McMaster University, Hamilton, Canada
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
May 16, 2014
First Posted
May 29, 2014
Study Start
July 7, 2014
Primary Completion
August 2, 2017
Study Completion
August 2, 2017
Last Updated
November 15, 2019
Results First Posted
September 13, 2019
Record last verified: 2019-11