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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02149199




Registration number
NCT02149199
Ethics application status
Date submitted
16/05/2014
Date registered
29/05/2014
Date last updated
15/11/2019

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 Terbutaline 'as Needed' and With Pulmicort® Twice Daily Plus Terbutaline 'as Needed' in Adult and Adolescent Patients With Asthma.
Secondary ID [1] 0 0
2013-004474-96
Secondary ID [2] 0 0
D589SC00001
Universal Trial Number (UTN)
Trial acronym
SYGMA1
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 - terbutaline 'as needed' + placebo budesonide bid
Treatment: Drugs - budesonide 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: terbutaline "as needed"+placebo Pulmicort bid - terbutaline Turbuhaler 0.4 mg 'as needed' + placebo Pulmicort 200 µg Turbuhaler 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: terbutaline 'as needed' + placebo budesonide bid
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

Treatment: Drugs: budesonide 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
'Well-controlled Asthma Week' - a Derived Binary Variable (Yes/No)
Timepoint [1] 0 0
Weekly, 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
Number of Participants Experiencing at Least One Moderate or Severe Asthma Exacerbation
Timepoint [2] 0 0
Day 1 up to 52 weeks
Secondary outcome [3] 0 0
Average Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1)
Timepoint [3] 0 0
Study weeks 0,4,16,28,40,52
Secondary outcome [4] 0 0
Average Change From Baseline in Morning Peak Expiratory Flow (PEF)
Timepoint [4] 0 0
up to 52 weeks
Secondary outcome [5] 0 0
Average Change From Baseline in Evening PEF
Timepoint [5] 0 0
up to 52 weeks
Secondary outcome [6] 0 0
Average Change From Baseline in Number of Inhalations of 'as Needed' Medication.
Timepoint [6] 0 0
up to 52 weeks
Secondary outcome [7] 0 0
Average Change From Baseline in Asthma Symptom Score
Timepoint [7] 0 0
up to 52 weeks
Secondary outcome [8] 0 0
Change From Baseline in the Percentage of Nighttime Awakenings Due to Asthma
Timepoint [8] 0 0
up to 52 weeks
Secondary outcome [9] 0 0
Change From Baseline in Percentage of Symptom-free Days
Timepoint [9] 0 0
up to 52 weeks
Secondary outcome [10] 0 0
Change From Baseline in Percentage of 'As Needed' Free Days
Timepoint [10] 0 0
up to 52 weeks
Secondary outcome [11] 0 0
Change From Baseline in Percentage of Asthma Control Days
Timepoint [11] 0 0
up to 52 weeks
Secondary outcome [12] 0 0
Number of Patients With Study Specific Asthma Related Discontinuation
Timepoint [12] 0 0
up to 52 weeks
Secondary outcome [13] 0 0
Poorly Controlled Asthma Weeks
Timepoint [13] 0 0
Weekly for up to 52 weeks
Secondary outcome [14] 0 0
Number of Participants Experiencing at Least One Occasion With Additional Steroids for Asthma
Timepoint [14] 0 0
Day 1 up to 52 weeks
Secondary outcome [15] 0 0
Average Change From Baseline in Asthma Control Questionnaire (ACQ-5)
Timepoint [15] 0 0
Study weeks 0,4,16,28,40,52
Secondary outcome [16] 0 0
Average Change From Baseline in Asthma Quality of Life Questionnaire; Standard Version (AQLQ(S))
Timepoint [16] 0 0
Study weeks 0,16,28,40,52
Secondary outcome [17] 0 0
Percentage of Controller Use Days
Timepoint [17] 0 0
up to 52 weeks
Secondary outcome [18] 0 0
Annual Severe Asthma Exacerbation Rate
Timepoint [18] 0 0
up to 52 weeks
Secondary outcome [19] 0 0
Annual Moderate or Severe Asthma Exacerbation Rate
Timepoint [19] 0 0
up to 52 weeks

Eligibility
Key inclusion criteria
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 Step 2 treatment according to Global Initiative for Asthma guidelines 5. Patients treated with 'as needed' inhaled short-acting bronchodilator(s) only should have pre-bronchodilator Forced Expiratory Volume in one second (FEV1) = 60 % of Predicted Normal (PN) and post-bronchodilator FEV1 = 80 % PN 6. Patients treated with low stable dose of inhaled corticosteroid or leukotriene antagonist in addition to 'as needed' use of inhaled short-acting bronchodilator(s) should have pre-bronchodilator FEV1 =80 % PN 7. Patients should have reversible airway obstruction 8. To be randomized patients must have used Bricanyl Turbuhaler 'as needed' on at least 3 separate days during the last week of the run in period. EXCLUSION CRITERIA 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 inhaled short-acting bronchodilator(s) within 30 days prior to Visit 1 or between Visits 1 and 2; or a treatment other than Bricanyl Turbuhaler from Visit 2 until randomization 3. Patient has required treatment with oral, rectal or parenteral glucocorticosteroids (GCS) within 30 days and/or depot parenteral GCS within 12 weeks prior to Visit 1 4. Smoker (current or previous) with a smoking history of = 10 pack years 5. Pregnancy, breast-feeding or planned pregnancy during the study.
Minimum age
12 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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
7/07/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/08/2017
Sample size
Target
Accrual to date
Final
3850
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Bedford Park
Recruitment hospital [2] 0 0
Research Site - Concord
Recruitment hospital [3] 0 0
Research Site - Maroubra
Recruitment hospital [4] 0 0
Research Site - Murdoch
Recruitment hospital [5] 0 0
Research Site - Wollongong
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2035 - Maroubra
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
Recruitment postcode(s) [5] 0 0
2522 - Wollongong
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Alphaville
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Brazil
State/province [2] 0 0
Botucatu
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Brazil
State/province [3] 0 0
Porto Alegre
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Brazil
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Salvador
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Brazil
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Santo Andre
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Brazil
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Sao Paulo
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Brazil
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Sorocaba
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Bulgaria
State/province [8] 0 0
Dupnitsa
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Bulgaria
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Gotse Delchev
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Bulgaria
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Kozloduy
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Bulgaria
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Pazardzhik
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Bulgaria
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Plovdiv
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Bulgaria
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Razgrad
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Bulgaria
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Roman
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Bulgaria
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Ruse
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Bulgaria
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Sandanski
Country [17] 0 0
Bulgaria
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Sofia
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Bulgaria
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Varna
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Bulgaria
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Velingrad
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Bulgaria
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Vratsa
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Newfoundland and Labrador
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Ontario
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Canada
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Quebec
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Chile
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Quillota
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Chile
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Santiago
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Chile
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Talcahuano
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China
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Beijing
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China
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Changsha
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China
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Chengdu
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China
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Guangzhou
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China
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Haikou
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China
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Hohhot
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China
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Nanchang
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China
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Shanghai
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China
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Shenyang
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China
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Wenzhou
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China
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Wuhan
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China
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Xi'an
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China
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Xiamen
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China
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Xuzhou
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Hungary
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Balassagyarmat
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Hungary
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Berettyóújfalu
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Budapest
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Edelény
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Hajdúnánás
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Miskolc
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Monor
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Mátészalka
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Nyíregyháza
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Hungary
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Pécs
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Hungary
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Szeged
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Korea, Republic of
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Bucheon-si
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Cheongju-si
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Cluj-Napoca
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Romania
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Pitesti
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Penza
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Russian Federation
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Perm
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Russian Federation
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Petrozavodsk
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Pyatigorsk
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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South Africa
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Durban
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South Africa
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Johannesburg
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South Africa
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Middelburg
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South Africa
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Queenswood
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South Africa
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Stanger
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South Africa
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Verulam
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Ukraine
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Cherkasy
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Ukraine
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Dnipropetrovsk
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Ukraine
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Ivano-Frankivsk
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
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Lutsk
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Lviv
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Ukraine
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Odesa
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Ukraine
State/province [138] 0 0
Vinnytsia
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Ukraine
State/province [139] 0 0
Zaporizhzhya
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United Kingdom
State/province [140] 0 0
Bath
Country [141] 0 0
United Kingdom
State/province [141] 0 0
Coventry
Country [142] 0 0
United Kingdom
State/province [142] 0 0
Leamington Spa
Country [143] 0 0
United Kingdom
State/province [143] 0 0
Mortimer Reading
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United Kingdom
State/province [144] 0 0
Trowbridge
Country [145] 0 0
Vietnam
State/province [145] 0 0
Dong Nai
Country [146] 0 0
Vietnam
State/province [146] 0 0
Hai Phong
Country [147] 0 0
Vietnam
State/province [147] 0 0
Hanoi
Country [148] 0 0
Vietnam
State/province [148] 0 0
Ho Chi Minh
Country [149] 0 0
Vietnam
State/province [149] 0 0
Hochiminh

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: 1) terbutaline Turbuhaler® 'as needed' and with 2) Pulmicort (budesonide) Turbuhaler® twice daily plus terbutaline Turbuhaler® 'as needed'.
Trial website
https://clinicaltrials.gov/study/NCT02149199
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.
O'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.
O'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.
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
Paul M O'Byrne, MB, FRCP(C), FRSC
Address 0 0
McMaster University, Hamilton, Canada
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/NCT02149199