Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02224157




Registration number
NCT02224157
Ethics application status
Date submitted
19/08/2014
Date registered
25/08/2014
Date last updated
25/11/2019

Titles & IDs
Public title
A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma
Scientific title
A Clinical Study Comparing Symbicort 'as Needed' With Pulmicort Twice Daily Plus Terbutaline 'as Needed' in Adult and Adolescent Patients With Asthma
Secondary ID [1] 0 0
2013-004473-28
Secondary ID [2] 0 0
D589SC00003
Universal Trial Number (UTN)
Trial acronym
SYGMA2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - budesonide/formoterol 'as needed' + budesonide placebo bid
Treatment: Drugs - budesonode bid + terbutaline 'as needed'

Experimental: Symbicort "as needed"+placebo Pulmicort bid - Symbicort (budesonide/formoterol) Turbuhaler 160/4.5 µg 'as needed' + Placebo Pulmicort Turbuhaler 200 µg bid

Active comparator: Pulmicort bid + terbutaline "as needed" - Pulmicort 200 µg Turbuhaler bid + terbutaline 0.4 mg Turbuhaler 'as needed'


Treatment: Drugs: budesonide/formoterol 'as needed' + budesonide placebo bid
Symbicort (budesonide/ formoterol) 160/4.5 µg powder for inhalation 'as needed' plus Pulmicort placebo 200 µg powder for inhalation, 1 inhalation twice daily (morning and evening), 52-week treatment

Treatment: Drugs: budesonode bid + terbutaline 'as needed'
Pulmicort (budesonide) 200 µg powder for inhalation, 1 inhalation twice daily (morning and evening) plus terbutaline 0.4 mg powder for inhalation 'as needed', 52-week treatment
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annual Severe Asthma Exacerbation Rate - Non-inferiority Analysis
Timepoint [1] 0 0
up to 52 weeks
Primary outcome [2] 0 0
Annual Severe Asthma Exacerbation Rate - Superiority Analysis
Timepoint [2] 0 0
up to 52 weeks
Secondary outcome [1] 0 0
Number of Participants Experiencing at Least One Severe Asthma Exacerbation
Timepoint [1] 0 0
Day 1 up to 52 weeks
Secondary outcome [2] 0 0
Average Change From Baseline in Pre-bronchodilator FEV1
Timepoint [2] 0 0
Study weeks 0,17, 34, 52
Secondary outcome [3] 0 0
Number of Participants With Study Specific Asthma Related Discontinuation
Timepoint [3] 0 0
Day 1 up to 52 weeks
Secondary outcome [4] 0 0
Average Change From Baseline in 'as Needed' Use
Timepoint [4] 0 0
Week 0 up to 52 weeks
Secondary outcome [5] 0 0
Change From Baseline in Percent of 'as Needed' Free Days
Timepoint [5] 0 0
Week 0 up to 52 weeks
Secondary outcome [6] 0 0
Percentage of Controller Use Days
Timepoint [6] 0 0
Week 0 up to 52 weeks
Secondary outcome [7] 0 0
Average Change From Baseline in Asthma Control Questionnaire (5-item Version) - ACQ-5 Score
Timepoint [7] 0 0
Study weeks 0, 17, 34, 52
Secondary outcome [8] 0 0
Average Change From Baseline in Asthma Quality of Life Questionnaire Standardised Version - AQLQ(S) Score
Timepoint [8] 0 0
Study weeks 0,17, 34, 52

Eligibility
Key inclusion criteria
1. 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
2. Male or Female, =12 years of age
3. Documented diagnosis of asthma for at least 6 months prior to Visit 1
4. Patients who are in need of GINA step 2 treatment
5. Patients treated with a short acting inhaled bronchodilator(s) only should have pre-bronchodilator FEV1 = 60 % of predicted normal (PN) and post-bronchodilator FEV1 = 80 % PN
6. Patients treated with low stable dose of ICS or leukotriene antagonists in addition to short acting inhaled bronchodilator(s) should have pre-bronchodilator FEV1 =80 % PN
7. Patients should have reversible airway obstruction
8. To be randomized patients must have used Bricanyl Turbuhaler as needed on at least 3 separate days during the last week of the run in period
Minimum age
12 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient has a history of life-threatening asthma including intubation and intensive care unit admission
2. Patient has had an asthma worsening requiring change in treatment other than short acting inhaled bronchodilator(s) within 30 days prior to Visit 1 and from Visit 1 until randomization
3. Patient has required treatment with oral, rectal or parenteral GCS within 30 days and/or depot parenteral GCS within 12 weeks prior to Visit 1
4. Current or previous smoker with a smoking history of = 10 pack years
5. Pregnancy, breast-feeding or planned pregnancy during the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/11/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/08/2017
Sample size
Target
Accrual to date
Final
4215
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Botucatu
Country [2] 0 0
Brazil
State/province [2] 0 0
Florianopolis
Country [3] 0 0
Brazil
State/province [3] 0 0
Goiania
Country [4] 0 0
Brazil
State/province [4] 0 0
Porto Alegre
Country [5] 0 0
Brazil
State/province [5] 0 0
Salvador
Country [6] 0 0
Brazil
State/province [6] 0 0
Santo Andre
Country [7] 0 0
Brazil
State/province [7] 0 0
Sao Paulo
Country [8] 0 0
Brazil
State/province [8] 0 0
Sorocaba
Country [9] 0 0
Brazil
State/province [9] 0 0
São Paulo
Country [10] 0 0
Bulgaria
State/province [10] 0 0
Blagoevgrad
Country [11] 0 0
Bulgaria
State/province [11] 0 0
Pernik
Country [12] 0 0
Bulgaria
State/province [12] 0 0
Petrich
Country [13] 0 0
Bulgaria
State/province [13] 0 0
Pleven
Country [14] 0 0
Bulgaria
State/province [14] 0 0
Razlog
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Sliven
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Smolyan
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Sofia
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Stara Zagora
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Varna
Country [20] 0 0
Bulgaria
State/province [20] 0 0
Veliko Tarnovo
Country [21] 0 0
Bulgaria
State/province [21] 0 0
Vidin
Country [22] 0 0
Bulgaria
State/province [22] 0 0
Yambol
Country [23] 0 0
Chile
State/province [23] 0 0
Curico
Country [24] 0 0
Chile
State/province [24] 0 0
Quillota
Country [25] 0 0
Chile
State/province [25] 0 0
Santiago
Country [26] 0 0
Chile
State/province [26] 0 0
Talca
Country [27] 0 0
Chile
State/province [27] 0 0
Viña del Mar
Country [28] 0 0
Colombia
State/province [28] 0 0
Barranquilla
Country [29] 0 0
Colombia
State/province [29] 0 0
Bogota
Country [30] 0 0
Colombia
State/province [30] 0 0
Bogotá
Country [31] 0 0
Colombia
State/province [31] 0 0
Medellin
Country [32] 0 0
Czechia
State/province [32] 0 0
Ceska Lipa
Country [33] 0 0
Czechia
State/province [33] 0 0
Kladno
Country [34] 0 0
Czechia
State/province [34] 0 0
Kralupy nad Vltavou
Country [35] 0 0
Czechia
State/province [35] 0 0
Kutna Hora
Country [36] 0 0
Czechia
State/province [36] 0 0
Liberec 1
Country [37] 0 0
Czechia
State/province [37] 0 0
Neratovice
Country [38] 0 0
Czechia
State/province [38] 0 0
Ostrava
Country [39] 0 0
Czechia
State/province [39] 0 0
Pardubice
Country [40] 0 0
Czechia
State/province [40] 0 0
Plzen
Country [41] 0 0
Czechia
State/province [41] 0 0
Praha 4
Country [42] 0 0
Czechia
State/province [42] 0 0
Praha 5
Country [43] 0 0
Czechia
State/province [43] 0 0
Praha
Country [44] 0 0
Czechia
State/province [44] 0 0
Rokycany
Country [45] 0 0
Czechia
State/province [45] 0 0
Rudna U Prahy
Country [46] 0 0
Czechia
State/province [46] 0 0
Tabor
Country [47] 0 0
Czechia
State/province [47] 0 0
Teplice
Country [48] 0 0
Czechia
State/province [48] 0 0
Zatec
Country [49] 0 0
France
State/province [49] 0 0
Brii-sous-forges
Country [50] 0 0
France
State/province [50] 0 0
Colmar
Country [51] 0 0
France
State/province [51] 0 0
Joue-les-Tours
Country [52] 0 0
France
State/province [52] 0 0
Nantes Cedex 2
Country [53] 0 0
France
State/province [53] 0 0
Nimes
Country [54] 0 0
France
State/province [54] 0 0
Reze
Country [55] 0 0
Germany
State/province [55] 0 0
Bad Lippspringe
Country [56] 0 0
Germany
State/province [56] 0 0
Berlin
Country [57] 0 0
Germany
State/province [57] 0 0
Cottbus
Country [58] 0 0
Germany
State/province [58] 0 0
Frankfurt/Main
Country [59] 0 0
Germany
State/province [59] 0 0
Geesthacht
Country [60] 0 0
Germany
State/province [60] 0 0
Großhansdorf
Country [61] 0 0
Germany
State/province [61] 0 0
Hamburg
Country [62] 0 0
Germany
State/province [62] 0 0
Hannover
Country [63] 0 0
Germany
State/province [63] 0 0
Leipzig
Country [64] 0 0
Germany
State/province [64] 0 0
Lübeck
Country [65] 0 0
Germany
State/province [65] 0 0
Neu-Isenburg
Country [66] 0 0
Germany
State/province [66] 0 0
Oldenburg
Country [67] 0 0
Germany
State/province [67] 0 0
Reinfeld
Country [68] 0 0
Germany
State/province [68] 0 0
Rüdersdorf
Country [69] 0 0
Germany
State/province [69] 0 0
Schleswig
Country [70] 0 0
Germany
State/province [70] 0 0
Warendorf
Country [71] 0 0
Hungary
State/province [71] 0 0
Aszód
Country [72] 0 0
Hungary
State/province [72] 0 0
Balassagyarmat
Country [73] 0 0
Hungary
State/province [73] 0 0
Berettyóújfalu
Country [74] 0 0
Hungary
State/province [74] 0 0
Budapest
Country [75] 0 0
Hungary
State/province [75] 0 0
Cegléd
Country [76] 0 0
Hungary
State/province [76] 0 0
Gyula
Country [77] 0 0
Hungary
State/province [77] 0 0
Gödöllo
Country [78] 0 0
Hungary
State/province [78] 0 0
Hajdúnánás
Country [79] 0 0
Hungary
State/province [79] 0 0
Létavértes
Country [80] 0 0
Hungary
State/province [80] 0 0
Makó
Country [81] 0 0
Hungary
State/province [81] 0 0
Miskolc
Country [82] 0 0
Hungary
State/province [82] 0 0
Mórahalom
Country [83] 0 0
Hungary
State/province [83] 0 0
Pécs
Country [84] 0 0
Hungary
State/province [84] 0 0
Siófok
Country [85] 0 0
Hungary
State/province [85] 0 0
Szeged
Country [86] 0 0
Hungary
State/province [86] 0 0
Szombathely
Country [87] 0 0
Hungary
State/province [87] 0 0
Vásárosnamény
Country [88] 0 0
Hungary
State/province [88] 0 0
Érd
Country [89] 0 0
Korea, Republic of
State/province [89] 0 0
Busan
Country [90] 0 0
Korea, Republic of
State/province [90] 0 0
Cheongju-si
Country [91] 0 0
Korea, Republic of
State/province [91] 0 0
Daegu
Country [92] 0 0
Korea, Republic of
State/province [92] 0 0
Incheon
Country [93] 0 0
Korea, Republic of
State/province [93] 0 0
Seongnam-si
Country [94] 0 0
Korea, Republic of
State/province [94] 0 0
Seoul
Country [95] 0 0
Korea, Republic of
State/province [95] 0 0
Suwon-si
Country [96] 0 0
Korea, Republic of
State/province [96] 0 0
Uijeongbu-si
Country [97] 0 0
Korea, Republic of
State/province [97] 0 0
Wonju-si
Country [98] 0 0
Mexico
State/province [98] 0 0
Chihuahua
Country [99] 0 0
Mexico
State/province [99] 0 0
Guadalajara
Country [100] 0 0
Mexico
State/province [100] 0 0
Mexico City
Country [101] 0 0
Mexico
State/province [101] 0 0
Mérida
Country [102] 0 0
Mexico
State/province [102] 0 0
México
Country [103] 0 0
Mexico
State/province [103] 0 0
San Juan del Rio
Country [104] 0 0
Mexico
State/province [104] 0 0
Tlanepantla
Country [105] 0 0
Mexico
State/province [105] 0 0
Villahermosa
Country [106] 0 0
Mexico
State/province [106] 0 0
Zapopan
Country [107] 0 0
New Zealand
State/province [107] 0 0
Auckland
Country [108] 0 0
New Zealand
State/province [108] 0 0
Christchurch Central
Country [109] 0 0
New Zealand
State/province [109] 0 0
Christchurch
Country [110] 0 0
New Zealand
State/province [110] 0 0
Grafton
Country [111] 0 0
New Zealand
State/province [111] 0 0
Hamilton West
Country [112] 0 0
New Zealand
State/province [112] 0 0
Maroubra
Country [113] 0 0
New Zealand
State/province [113] 0 0
New Lambton
Country [114] 0 0
New Zealand
State/province [114] 0 0
Newtown
Country [115] 0 0
New Zealand
State/province [115] 0 0
Rotorua
Country [116] 0 0
New Zealand
State/province [116] 0 0
South Brisbane
Country [117] 0 0
New Zealand
State/province [117] 0 0
Tauranga
Country [118] 0 0
New Zealand
State/province [118] 0 0
Wellington
Country [119] 0 0
Peru
State/province [119] 0 0
Cercado De Lima
Country [120] 0 0
Peru
State/province [120] 0 0
Chancay
Country [121] 0 0
Peru
State/province [121] 0 0
Lima
Country [122] 0 0
Peru
State/province [122] 0 0
Miraflores
Country [123] 0 0
Peru
State/province [123] 0 0
Santa Beatriz
Country [124] 0 0
Philippines
State/province [124] 0 0
Lipa City
Country [125] 0 0
Philippines
State/province [125] 0 0
Manila
Country [126] 0 0
Philippines
State/province [126] 0 0
Pasig City
Country [127] 0 0
Philippines
State/province [127] 0 0
Quezon City
Country [128] 0 0
Poland
State/province [128] 0 0
Bialystok
Country [129] 0 0
Poland
State/province [129] 0 0
Gizycko
Country [130] 0 0
Poland
State/province [130] 0 0
Koscian
Country [131] 0 0
Poland
State/province [131] 0 0
Kraków
Country [132] 0 0
Poland
State/province [132] 0 0
Lublin
Country [133] 0 0
Poland
State/province [133] 0 0
Mragowo
Country [134] 0 0
Poland
State/province [134] 0 0
Ostrowiec Swietokrzyski
Country [135] 0 0
Poland
State/province [135] 0 0
Ostrów Wielkopolski
Country [136] 0 0
Poland
State/province [136] 0 0
Pabianice
Country [137] 0 0
Poland
State/province [137] 0 0
Pila
Country [138] 0 0
Poland
State/province [138] 0 0
Poznan
Country [139] 0 0
Poland
State/province [139] 0 0
Proszowice
Country [140] 0 0
Poland
State/province [140] 0 0
Rzeszów
Country [141] 0 0
Poland
State/province [141] 0 0
Warszawa
Country [142] 0 0
Poland
State/province [142] 0 0
Zabrze
Country [143] 0 0
Romania
State/province [143] 0 0
Bragadiru
Country [144] 0 0
Romania
State/province [144] 0 0
Brasov
Country [145] 0 0
Romania
State/province [145] 0 0
Bucharest
Country [146] 0 0
Romania
State/province [146] 0 0
Constanta
Country [147] 0 0
Romania
State/province [147] 0 0
Deva
Country [148] 0 0
Romania
State/province [148] 0 0
Iasi
Country [149] 0 0
Romania
State/province [149] 0 0
Pitesti
Country [150] 0 0
Russian Federation
State/province [150] 0 0
Chelyabinsk
Country [151] 0 0
Russian Federation
State/province [151] 0 0
Ekaterinburg
Country [152] 0 0
Russian Federation
State/province [152] 0 0
Gatchina
Country [153] 0 0
Russian Federation
State/province [153] 0 0
Ivanovo
Country [154] 0 0
Russian Federation
State/province [154] 0 0
Izhevsk
Country [155] 0 0
Russian Federation
State/province [155] 0 0
Kazan
Country [156] 0 0
Russian Federation
State/province [156] 0 0
Kemerovo
Country [157] 0 0
Russian Federation
State/province [157] 0 0
Moscow
Country [158] 0 0
Russian Federation
State/province [158] 0 0
Novosibirsk
Country [159] 0 0
Russian Federation
State/province [159] 0 0
Omsk
Country [160] 0 0
Russian Federation
State/province [160] 0 0
Penza
Country [161] 0 0
Russian Federation
State/province [161] 0 0
Perm
Country [162] 0 0
Russian Federation
State/province [162] 0 0
Pskov
Country [163] 0 0
Russian Federation
State/province [163] 0 0
Saint - Petersburg
Country [164] 0 0
Russian Federation
State/province [164] 0 0
Saint Petersburg
Country [165] 0 0
Russian Federation
State/province [165] 0 0
Saint-Petersburg
Country [166] 0 0
Russian Federation
State/province [166] 0 0
Saratov
Country [167] 0 0
Russian Federation
State/province [167] 0 0
St. Petersburg
Country [168] 0 0
Russian Federation
State/province [168] 0 0
St.Petersburg
Country [169] 0 0
Russian Federation
State/province [169] 0 0
Tomsk
Country [170] 0 0
Russian Federation
State/province [170] 0 0
Tver
Country [171] 0 0
Russian Federation
State/province [171] 0 0
Ufa
Country [172] 0 0
Russian Federation
State/province [172] 0 0
Ulyanovsk
Country [173] 0 0
Russian Federation
State/province [173] 0 0
Vladikavkaz
Country [174] 0 0
Russian Federation
State/province [174] 0 0
Volgograd
Country [175] 0 0
Russian Federation
State/province [175] 0 0
Vsevolozhsk
Country [176] 0 0
Russian Federation
State/province [176] 0 0
Yaroslavl
Country [177] 0 0
Saudi Arabia
State/province [177] 0 0
Dhahran
Country [178] 0 0
Saudi Arabia
State/province [178] 0 0
Jeddah
Country [179] 0 0
Saudi Arabia
State/province [179] 0 0
Riyadh
Country [180] 0 0
Slovakia
State/province [180] 0 0
Kezmarok
Country [181] 0 0
Slovakia
State/province [181] 0 0
Komarno
Country [182] 0 0
Slovakia
State/province [182] 0 0
Kosice
Country [183] 0 0
Slovakia
State/province [183] 0 0
Levice
Country [184] 0 0
Slovakia
State/province [184] 0 0
Liptovsky Mikulas
Country [185] 0 0
Slovakia
State/province [185] 0 0
Lucenec
Country [186] 0 0
Slovakia
State/province [186] 0 0
Nitra
Country [187] 0 0
Slovakia
State/province [187] 0 0
Nove Zamky
Country [188] 0 0
Slovakia
State/province [188] 0 0
Poprad
Country [189] 0 0
Slovakia
State/province [189] 0 0
Rimavska Sobota
Country [190] 0 0
Slovakia
State/province [190] 0 0
Ruzomberok
Country [191] 0 0
Slovakia
State/province [191] 0 0
Skalica
Country [192] 0 0
Slovakia
State/province [192] 0 0
Surany
Country [193] 0 0
Slovakia
State/province [193] 0 0
Topolcany
Country [194] 0 0
Slovakia
State/province [194] 0 0
Trebisov
Country [195] 0 0
Slovakia
State/province [195] 0 0
Zilina
Country [196] 0 0
Slovakia
State/province [196] 0 0
Zvolen
Country [197] 0 0
South Africa
State/province [197] 0 0
Bellville
Country [198] 0 0
South Africa
State/province [198] 0 0
Boksburg North
Country [199] 0 0
South Africa
State/province [199] 0 0
Cape Town
Country [200] 0 0
South Africa
State/province [200] 0 0
Durban
Country [201] 0 0
South Africa
State/province [201] 0 0
Johannesburg
Country [202] 0 0
South Africa
State/province [202] 0 0
Lenasia
Country [203] 0 0
South Africa
State/province [203] 0 0
Mowbray
Country [204] 0 0
South Africa
State/province [204] 0 0
Panorama
Country [205] 0 0
South Africa
State/province [205] 0 0
Phoenix
Country [206] 0 0
South Africa
State/province [206] 0 0
Verulam
Country [207] 0 0
Spain
State/province [207] 0 0
Alicante
Country [208] 0 0
Spain
State/province [208] 0 0
Badalona
Country [209] 0 0
Spain
State/province [209] 0 0
Barcelona
Country [210] 0 0
Spain
State/province [210] 0 0
Bilbao (Vizcaya)
Country [211] 0 0
Spain
State/province [211] 0 0
Madrid
Country [212] 0 0
Spain
State/province [212] 0 0
Malaga
Country [213] 0 0
Spain
State/province [213] 0 0
Marbella (Málaga)
Country [214] 0 0
Spain
State/province [214] 0 0
Oviedo
Country [215] 0 0
Spain
State/province [215] 0 0
Sevilla
Country [216] 0 0
Spain
State/province [216] 0 0
Terrassa (Barcelona)
Country [217] 0 0
Spain
State/province [217] 0 0
Valencia
Country [218] 0 0
Sweden
State/province [218] 0 0
Borås
Country [219] 0 0
Sweden
State/province [219] 0 0
Lund
Country [220] 0 0
Sweden
State/province [220] 0 0
Malmo
Country [221] 0 0
Sweden
State/province [221] 0 0
Stockholm
Country [222] 0 0
Sweden
State/province [222] 0 0
Värnamo
Country [223] 0 0
Sweden
State/province [223] 0 0
Västra Frölunda
Country [224] 0 0
Thailand
State/province [224] 0 0
Bangkok
Country [225] 0 0
Thailand
State/province [225] 0 0
Chonburi
Country [226] 0 0
Thailand
State/province [226] 0 0
Hat Yai
Country [227] 0 0
Thailand
State/province [227] 0 0
Khon Kaen
Country [228] 0 0
Thailand
State/province [228] 0 0
Muang,
Country [229] 0 0
Thailand
State/province [229] 0 0
Nonthaburi
Country [230] 0 0
Thailand
State/province [230] 0 0
Pathumthani
Country [231] 0 0
Ukraine
State/province [231] 0 0
Cherkasy
Country [232] 0 0
Ukraine
State/province [232] 0 0
Chernihiv
Country [233] 0 0
Ukraine
State/province [233] 0 0
Chernivtsi
Country [234] 0 0
Ukraine
State/province [234] 0 0
Dnipro
Country [235] 0 0
Ukraine
State/province [235] 0 0
Ivano-Frankivsk
Country [236] 0 0
Ukraine
State/province [236] 0 0
Kharkiv
Country [237] 0 0
Ukraine
State/province [237] 0 0
Kherson
Country [238] 0 0
Ukraine
State/province [238] 0 0
Kyiv
Country [239] 0 0
Ukraine
State/province [239] 0 0
Lutsk
Country [240] 0 0
Ukraine
State/province [240] 0 0
Lviv
Country [241] 0 0
Ukraine
State/province [241] 0 0
Odesa
Country [242] 0 0
Ukraine
State/province [242] 0 0
Odessa
Country [243] 0 0
Ukraine
State/province [243] 0 0
Ternopil
Country [244] 0 0
Ukraine
State/province [244] 0 0
Uzhgorod
Country [245] 0 0
Ukraine
State/province [245] 0 0
Vinnytsia
Country [246] 0 0
Ukraine
State/province [246] 0 0
Zaporizhzhya
Country [247] 0 0
Vietnam
State/province [247] 0 0
Can Tho
Country [248] 0 0
Vietnam
State/province [248] 0 0
Ha Noi
Country [249] 0 0
Vietnam
State/province [249] 0 0
Hanoi
Country [250] 0 0
Vietnam
State/province [250] 0 0
Ho Chi Minh
Country [251] 0 0
Vietnam
State/province [251] 0 0
Hochiminh
Country [252] 0 0
Vietnam
State/province [252] 0 0
Hue

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT02224157
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Carin Jorup, MD
Address 0 0
AstraZeneca Research & Development
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02224157