A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma (SYGMA2)
Primary Purpose
Asthma
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
budesonide/formoterol 'as needed' + budesonide placebo bid
budesonode bid + terbutaline 'as needed'
Sponsored by

About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
Inclusion Criteria:
- Provision of informed consent prior to any study specific procedures. For patients under-age, signed informed consent from both the patient and the patient's parent/legal guardian is required
- Male or Female, ≥12 years of age
- Documented diagnosis of asthma for at least 6 months prior to Visit 1
- Patients who are in need of GINA step 2 treatment
- Patients treated with a short acting inhaled bronchodilator(s) only should have pre-bronchodilator FEV1 ≥ 60 % of predicted normal (PN) and post-bronchodilator FEV1 ≥ 80 % PN
- Patients treated with low stable dose of ICS or leukotriene antagonists in addition to short acting inhaled bronchodilator(s) should have pre-bronchodilator FEV1 ≥80 % PN
- Patients should have reversible airway obstruction
- To be randomized patients must have used Bricanyl Turbuhaler as needed on at least 3 separate days during the last week of the run in period
Exclusion Criteria:
- Patient has a history of life-threatening asthma including intubation and intensive care unit admission
- Patient has had an asthma worsening requiring change in treatment other than short acting inhaled bronchodilator(s) within 30 days prior to Visit 1 and from Visit 1 until randomization
- Patient has required treatment with oral, rectal or parenteral GCS within 30 days and/or depot parenteral GCS within 12 weeks prior to Visit 1
- Current or previous smoker with a smoking history of ≥ 10 pack years
- Pregnancy, breast-feeding or planned pregnancy during the study
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Symbicort "as needed"+placebo Pulmicort bid
Pulmicort bid + terbutaline "as needed"
Arm Description
Symbicort (budesonide/formoterol) Turbuhaler 160/4.5 μg 'as needed' + Placebo Pulmicort Turbuhaler 200 μg bid
Pulmicort 200 μg Turbuhaler bid + terbutaline 0.4 mg Turbuhaler 'as needed'
Outcomes
Primary Outcome Measures
Annual Severe Asthma Exacerbation Rate - Non-inferiority Analysis
Severe asthma exacerbations over the randomised treatment period, negative binomial model for non-inferiority test evaluation
Annual Severe Asthma Exacerbation Rate - Superiority Analysis
Severe asthma exacerbations over the randomised treatment period, negative binomial model for superiority test evaluation
Secondary Outcome Measures
Number of Participants Experiencing at Least One Severe Asthma Exacerbation
A severe exacerbation is defined as a deterioration of asthma requiring any of the following: use of systemic glucocorticosteroids (GCS) for at least 3 days, inpatient hospitalization, or emergency room visit due to asthma that required systemic steroids.
Average Change From Baseline in Pre-bronchodilator FEV1
The average change from baseline (baseline defined by measurement at week 0, prior to first dose of IP) to the treatment period average assessed over the entire treatment period in pre-bronchodilator FEV1 was derived by computing a contrast for the mean across the post-randomisation visits (week 17, 34, 52) from the MMRM (mixed model repeated measures) analysis.
Number of Participants With Study Specific Asthma Related Discontinuation
The following two criteria lead to discontinuation from the IP due to asthma related events: A severe asthma exacerbation with duration for more than 3 weeks, and/or three severe asthma exacerbations during 6 months.
Average Change From Baseline in 'as Needed' Use
'As-needed' use change from baseline over the randomised treatment period. Baseline was defined as the last 10 days of the run-in period. 'As needed' use was calculated as the cumulative doses of 'as-needed' medication over the randomised treatment period divided by the follow-up time (number of days - 1). ie, average number of inhalations per day.
Change From Baseline in Percent of 'as Needed' Free Days
'As needed' free days (%) change from baseline during randomised treatment period. An 'as-needed' free day was defined as a day and night with no use of 'as needed' medication. Variable analysed is the percentage (%) of 'as-needed' free days during the randomised treatment period. Baseline is defined by the last 10 days of the run-in period.
Percentage of Controller Use Days
ICS controller use days (%) during the randomised treatment period is calculated as the cumulative days when any controller medication (containing ICS) was taken including maintenance (Pulmicort bid group) and 'as needed' medication (Symbicort 'as needed' group) and additional prescribed ICS for asthma (all treatment groups), divided by the number of days in the randomised treatment period.
Average Change From Baseline in Asthma Control Questionnaire (5-item Version) - ACQ-5 Score
ACQ questionnaire contains five questions on patients' symptoms, which are assessed on a 7-point scale from 0 (representing good control) to 6 (representing poor control). The score is the mean score of all questions for which responses are provided. The average change from baseline to treatment period average in ACQ-5 was derived by computing a contrast for the mean across all post-randomisation visits (week 17, 34, 52) from the MMRM (mixed model repeated measures) analysis.
Average Change From Baseline in Asthma Quality of Life Questionnaire Standardised Version - AQLQ(S) Score
AQLQ(S) consists of 32 questions in 4 domains. Each question is assessed on a 7-point scale from 1 to 7, with higher values indicating better health-related quality of life. The overall score is calculated as the mean score of all 32 items. The average change from baseline to treatment period average in AQLQ(S) overall score was derived by computing a contrast for the mean across all post-randomisation visits (week 17, 34, 52) from the MMRM (mixed model repeated measures) analysis.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02224157
Brief Title
A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma
Acronym
SYGMA2
Official Title
A Clinical Study Comparing Symbicort 'as Needed' With Pulmicort Twice Daily Plus Terbutaline 'as Needed' in Adult and Adolescent Patients With Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
November 28, 2014 (Actual)
Primary Completion Date
August 16, 2017 (Actual)
Study Completion Date
August 16, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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'
Detailed Description
A 52-week, double-blind, randomised, multi-centre, phase III, parallel-group study in patients 12 years and older with asthma, evaluating the efficacy and safety of Symbicort (budesonide/formoterol) Turbuhaler 160/4.5 μg 'as needed' compared with Pulmicort (budesonide) Turbuhaler 200 μg twice daily plus terbutaline Turbuhaler 0.4 mg 'as needed'
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
4215 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Symbicort "as needed"+placebo Pulmicort bid
Arm Type
Experimental
Arm Description
Symbicort (budesonide/formoterol) Turbuhaler 160/4.5 μg 'as needed' + Placebo Pulmicort Turbuhaler 200 μg bid
Arm Title
Pulmicort bid + terbutaline "as needed"
Arm Type
Active Comparator
Arm Description
Pulmicort 200 μg Turbuhaler bid + terbutaline 0.4 mg Turbuhaler 'as needed'
Intervention Type
Drug
Intervention Name(s)
budesonide/formoterol 'as needed' + budesonide placebo bid
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
budesonode bid + terbutaline 'as needed'
Intervention Description
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
Primary Outcome Measure Information:
Title
Annual Severe Asthma Exacerbation Rate - Non-inferiority Analysis
Description
Severe asthma exacerbations over the randomised treatment period, negative binomial model for non-inferiority test evaluation
Time Frame
up to 52 weeks
Title
Annual Severe Asthma Exacerbation Rate - Superiority Analysis
Description
Severe asthma exacerbations over the randomised treatment period, negative binomial model for superiority test evaluation
Time Frame
up to 52 weeks
Secondary Outcome Measure Information:
Title
Number of Participants Experiencing at Least One Severe Asthma Exacerbation
Description
A severe exacerbation is defined as a deterioration of asthma requiring any of the following: use of systemic glucocorticosteroids (GCS) for at least 3 days, inpatient hospitalization, or emergency room visit due to asthma that required systemic steroids.
Time Frame
Day 1 up to 52 weeks
Title
Average Change From Baseline in Pre-bronchodilator FEV1
Description
The average change from baseline (baseline defined by measurement at week 0, prior to first dose of IP) to the treatment period average assessed over the entire treatment period in pre-bronchodilator FEV1 was derived by computing a contrast for the mean across the post-randomisation visits (week 17, 34, 52) from the MMRM (mixed model repeated measures) analysis.
Time Frame
Study weeks 0,17, 34, 52
Title
Number of Participants With Study Specific Asthma Related Discontinuation
Description
The following two criteria lead to discontinuation from the IP due to asthma related events: A severe asthma exacerbation with duration for more than 3 weeks, and/or three severe asthma exacerbations during 6 months.
Time Frame
Day 1 up to 52 weeks
Title
Average Change From Baseline in 'as Needed' Use
Description
'As-needed' use change from baseline over the randomised treatment period. Baseline was defined as the last 10 days of the run-in period. 'As needed' use was calculated as the cumulative doses of 'as-needed' medication over the randomised treatment period divided by the follow-up time (number of days - 1). ie, average number of inhalations per day.
Time Frame
Week 0 up to 52 weeks
Title
Change From Baseline in Percent of 'as Needed' Free Days
Description
'As needed' free days (%) change from baseline during randomised treatment period. An 'as-needed' free day was defined as a day and night with no use of 'as needed' medication. Variable analysed is the percentage (%) of 'as-needed' free days during the randomised treatment period. Baseline is defined by the last 10 days of the run-in period.
Time Frame
Week 0 up to 52 weeks
Title
Percentage of Controller Use Days
Description
ICS controller use days (%) during the randomised treatment period is calculated as the cumulative days when any controller medication (containing ICS) was taken including maintenance (Pulmicort bid group) and 'as needed' medication (Symbicort 'as needed' group) and additional prescribed ICS for asthma (all treatment groups), divided by the number of days in the randomised treatment period.
Time Frame
Week 0 up to 52 weeks
Title
Average Change From Baseline in Asthma Control Questionnaire (5-item Version) - ACQ-5 Score
Description
ACQ questionnaire contains five questions on patients' symptoms, which are assessed on a 7-point scale from 0 (representing good control) to 6 (representing poor control). The score is the mean score of all questions for which responses are provided. The average change from baseline to treatment period average in ACQ-5 was derived by computing a contrast for the mean across all post-randomisation visits (week 17, 34, 52) from the MMRM (mixed model repeated measures) analysis.
Time Frame
Study weeks 0, 17, 34, 52
Title
Average Change From Baseline in Asthma Quality of Life Questionnaire Standardised Version - AQLQ(S) Score
Description
AQLQ(S) consists of 32 questions in 4 domains. Each question is assessed on a 7-point scale from 1 to 7, with higher values indicating better health-related quality of life. The overall score is calculated as the mean score of all 32 items. The average change from baseline to treatment period average in AQLQ(S) overall score was derived by computing a contrast for the mean across all post-randomisation visits (week 17, 34, 52) from the MMRM (mixed model repeated measures) analysis.
Time Frame
Study weeks 0,17, 34, 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of informed consent prior to any study specific procedures. For patients under-age, signed informed consent from both the patient and the patient's parent/legal guardian is required
Male or Female, ≥12 years of age
Documented diagnosis of asthma for at least 6 months prior to Visit 1
Patients who are in need of GINA step 2 treatment
Patients treated with a short acting inhaled bronchodilator(s) only should have pre-bronchodilator FEV1 ≥ 60 % of predicted normal (PN) and post-bronchodilator FEV1 ≥ 80 % PN
Patients treated with low stable dose of ICS or leukotriene antagonists in addition to short acting inhaled bronchodilator(s) should have pre-bronchodilator FEV1 ≥80 % PN
Patients should have reversible airway obstruction
To be randomized patients must have used Bricanyl Turbuhaler as needed on at least 3 separate days during the last week of the run in period
Exclusion Criteria:
Patient has a history of life-threatening asthma including intubation and intensive care unit admission
Patient has had an asthma worsening requiring change in treatment other than short acting inhaled bronchodilator(s) within 30 days prior to Visit 1 and from Visit 1 until randomization
Patient has required treatment with oral, rectal or parenteral GCS within 30 days and/or depot parenteral GCS within 12 weeks prior to Visit 1
Current or previous smoker with a smoking history of ≥ 10 pack years
Pregnancy, breast-feeding or planned pregnancy during the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carin Jorup, MD
Organizational Affiliation
AstraZeneca Research & Development
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Sydney
ZIP/Postal Code
2010
Country
Australia
Facility Name
Research Site
City
Botucatu
ZIP/Postal Code
18618-970
Country
Brazil
Facility Name
Research Site
City
Florianopolis
ZIP/Postal Code
88040-970
Country
Brazil
Facility Name
Research Site
City
Goiania
ZIP/Postal Code
74110 030
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
9002-060
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90020-060
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90110-270
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Research Site
City
Salvador
ZIP/Postal Code
41940-455
Country
Brazil
Facility Name
Research Site
City
Santo Andre
ZIP/Postal Code
09080-110
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
04020-060
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
04101-000
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
04266-010
Country
Brazil
Facility Name
Research Site
City
Sorocaba
ZIP/Postal Code
18040-425
Country
Brazil
Facility Name
Research Site
City
São Paulo
ZIP/Postal Code
02189-000
Country
Brazil
Facility Name
Research Site
City
São Paulo
ZIP/Postal Code
05403-900
Country
Brazil
Facility Name
Research Site
City
Blagoevgrad
ZIP/Postal Code
2700
Country
Bulgaria
Facility Name
Research Site
City
Pernik
ZIP/Postal Code
2300
Country
Bulgaria
Facility Name
Research Site
City
Petrich
ZIP/Postal Code
2850
Country
Bulgaria
Facility Name
Research Site
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Research Site
City
Razlog
ZIP/Postal Code
2760
Country
Bulgaria
Facility Name
Research Site
City
Sliven
ZIP/Postal Code
8800
Country
Bulgaria
Facility Name
Research Site
City
Smolyan
ZIP/Postal Code
4700
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1404
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1408
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1618
Country
Bulgaria
Facility Name
Research Site
City
Sofia
Country
Bulgaria
Facility Name
Research Site
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
Research Site
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Facility Name
Research Site
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
Research Site
City
Vidin
ZIP/Postal Code
3700
Country
Bulgaria
Facility Name
Research Site
City
Yambol
ZIP/Postal Code
8600
Country
Bulgaria
Facility Name
Research Site
City
Curico
ZIP/Postal Code
3341643
Country
Chile
Facility Name
Research Site
City
Quillota
ZIP/Postal Code
2260000
Country
Chile
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
404366
Country
Chile
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
8207257
Country
Chile
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
8320000
Country
Chile
Facility Name
Research Site
City
Talca
ZIP/Postal Code
3465584
Country
Chile
Facility Name
Research Site
City
Viña del Mar
ZIP/Postal Code
2520000
Country
Chile
Facility Name
Research Site
City
Barranquilla
ZIP/Postal Code
80001
Country
Colombia
Facility Name
Research Site
City
Bogota
ZIP/Postal Code
111511
Country
Colombia
Facility Name
Research Site
City
Bogotá
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Research Site
City
Bogotá
ZIP/Postal Code
111211
Country
Colombia
Facility Name
Research Site
City
Medellin
ZIP/Postal Code
5001000
Country
Colombia
Facility Name
Research Site
City
Ceska Lipa
ZIP/Postal Code
470 01
Country
Czechia
Facility Name
Research Site
City
Kladno
ZIP/Postal Code
272 00
Country
Czechia
Facility Name
Research Site
City
Kralupy nad Vltavou
ZIP/Postal Code
278 01
Country
Czechia
Facility Name
Research Site
City
Kutna Hora
ZIP/Postal Code
284 01
Country
Czechia
Facility Name
Research Site
City
Liberec 1
ZIP/Postal Code
460 01
Country
Czechia
Facility Name
Research Site
City
Neratovice
ZIP/Postal Code
277 01
Country
Czechia
Facility Name
Research Site
City
Ostrava
ZIP/Postal Code
709 00
Country
Czechia
Facility Name
Research Site
City
Ostrava
ZIP/Postal Code
728 80
Country
Czechia
Facility Name
Research Site
City
Pardubice
ZIP/Postal Code
532 03
Country
Czechia
Facility Name
Research Site
City
Plzen
ZIP/Postal Code
301 00
Country
Czechia
Facility Name
Research Site
City
Plzen
ZIP/Postal Code
304 60
Country
Czechia
Facility Name
Research Site
City
Praha 4
ZIP/Postal Code
142 00
Country
Czechia
Facility Name
Research Site
City
Praha 5
ZIP/Postal Code
150 00
Country
Czechia
Facility Name
Research Site
City
Praha
ZIP/Postal Code
169 00
Country
Czechia
Facility Name
Research Site
City
Rokycany
ZIP/Postal Code
337 22
Country
Czechia
Facility Name
Research Site
City
Rudna U Prahy
ZIP/Postal Code
252 19
Country
Czechia
Facility Name
Research Site
City
Tabor
ZIP/Postal Code
390 01
Country
Czechia
Facility Name
Research Site
City
Teplice
ZIP/Postal Code
415 01
Country
Czechia
Facility Name
Research Site
City
Zatec
ZIP/Postal Code
43801
Country
Czechia
Facility Name
Research Site
City
Brii-sous-forges
ZIP/Postal Code
91640
Country
France
Facility Name
Research Site
City
Colmar
ZIP/Postal Code
68000
Country
France
Facility Name
Research Site
City
Joue-les-Tours
ZIP/Postal Code
37300
Country
France
Facility Name
Research Site
City
Nantes Cedex 2
ZIP/Postal Code
44277
Country
France
Facility Name
Research Site
City
Nimes
ZIP/Postal Code
30000
Country
France
Facility Name
Research Site
City
Reze
ZIP/Postal Code
44400
Country
France
Facility Name
Research Site
City
Bad Lippspringe
ZIP/Postal Code
33175
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
10119
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
10367
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
10629
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
10787
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
13507
Country
Germany
Facility Name
Research Site
City
Cottbus
ZIP/Postal Code
03050
Country
Germany
Facility Name
Research Site
City
Frankfurt/Main
ZIP/Postal Code
60389
Country
Germany
Facility Name
Research Site
City
Geesthacht
ZIP/Postal Code
21502
Country
Germany
Facility Name
Research Site
City
Großhansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Research Site
City
Hamburg
ZIP/Postal Code
20354
Country
Germany
Facility Name
Research Site
City
Hannover
ZIP/Postal Code
D-30173
Country
Germany
Facility Name
Research Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Research Site
City
Leipzig
ZIP/Postal Code
04207
Country
Germany
Facility Name
Research Site
City
Leipzig
ZIP/Postal Code
04357
Country
Germany
Facility Name
Research Site
City
Lübeck
ZIP/Postal Code
23552
Country
Germany
Facility Name
Research Site
City
Neu-Isenburg
ZIP/Postal Code
63263
Country
Germany
Facility Name
Research Site
City
Oldenburg
ZIP/Postal Code
23758
Country
Germany
Facility Name
Research Site
City
Reinfeld
ZIP/Postal Code
23858
Country
Germany
Facility Name
Research Site
City
Rüdersdorf
ZIP/Postal Code
15562
Country
Germany
Facility Name
Research Site
City
Schleswig
ZIP/Postal Code
24837
Country
Germany
Facility Name
Research Site
City
Warendorf
ZIP/Postal Code
48231
Country
Germany
Facility Name
Research Site
City
Aszód
ZIP/Postal Code
2170
Country
Hungary
Facility Name
Research Site
City
Balassagyarmat
ZIP/Postal Code
2660
Country
Hungary
Facility Name
Research Site
City
Berettyóújfalu
ZIP/Postal Code
4100
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1191
Country
Hungary
Facility Name
Research Site
City
Cegléd
ZIP/Postal Code
2700
Country
Hungary
Facility Name
Research Site
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Research Site
City
Gyula
ZIP/Postal Code
5703
Country
Hungary
Facility Name
Research Site
City
Gödöllő
ZIP/Postal Code
2100
Country
Hungary
Facility Name
Research Site
City
Hajdúnánás
ZIP/Postal Code
4080
Country
Hungary
Facility Name
Research Site
City
Létavértes
ZIP/Postal Code
4281
Country
Hungary
Facility Name
Research Site
City
Makó
ZIP/Postal Code
6900
Country
Hungary
Facility Name
Research Site
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Research Site
City
Mórahalom
ZIP/Postal Code
6782
Country
Hungary
Facility Name
Research Site
City
Pécs
ZIP/Postal Code
7635
Country
Hungary
Facility Name
Research Site
City
Siófok
ZIP/Postal Code
8600
Country
Hungary
Facility Name
Research Site
City
Szeged
ZIP/Postal Code
H-6722
Country
Hungary
Facility Name
Research Site
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Research Site
City
Vásárosnamény
ZIP/Postal Code
4800
Country
Hungary
Facility Name
Research Site
City
Érd
ZIP/Postal Code
2030
Country
Hungary
Facility Name
Research Site
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
Research Site
City
Cheongju-si
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
Research Site
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Facility Name
Research Site
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
Facility Name
Research Site
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03312
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
04401
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Research Site
City
Suwon-si
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
Research Site
City
Uijeongbu-si
ZIP/Postal Code
11765
Country
Korea, Republic of
Facility Name
Research Site
City
Wonju-si
ZIP/Postal Code
26426
Country
Korea, Republic of
Facility Name
Research Site
City
Chihuahua
ZIP/Postal Code
31203
Country
Mexico
Facility Name
Research Site
City
Guadalajara
ZIP/Postal Code
44100
Country
Mexico
Facility Name
Research Site
City
Guadalajara
ZIP/Postal Code
44670
Country
Mexico
Facility Name
Research Site
City
Mexico City
ZIP/Postal Code
6726
Country
Mexico
Facility Name
Research Site
City
Mérida
ZIP/Postal Code
97070
Country
Mexico
Facility Name
Research Site
City
México
ZIP/Postal Code
06720
Country
Mexico
Facility Name
Research Site
City
San Juan del Rio
ZIP/Postal Code
76800
Country
Mexico
Facility Name
Research Site
City
Tlanepantla
ZIP/Postal Code
54055
Country
Mexico
Facility Name
Research Site
City
Villahermosa
ZIP/Postal Code
86035
Country
Mexico
Facility Name
Research Site
City
Zapopan
ZIP/Postal Code
45200
Country
Mexico
Facility Name
Research Site
City
Auckland
ZIP/Postal Code
0626
Country
New Zealand
Facility Name
Research Site
City
Christchurch Central
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Research Site
City
Christchurch
ZIP/Postal Code
8024
Country
New Zealand
Facility Name
Research Site
City
Christchurch
ZIP/Postal Code
8041
Country
New Zealand
Facility Name
Research Site
City
Grafton
ZIP/Postal Code
1010
Country
New Zealand
Facility Name
Research Site
City
Hamilton West
ZIP/Postal Code
3204
Country
New Zealand
Facility Name
Research Site
City
Maroubra
ZIP/Postal Code
2035
Country
New Zealand
Facility Name
Research Site
City
New Lambton
ZIP/Postal Code
2310
Country
New Zealand
Facility Name
Research Site
City
Newtown
ZIP/Postal Code
6242
Country
New Zealand
Facility Name
Research Site
City
Rotorua
ZIP/Postal Code
3010
Country
New Zealand
Facility Name
Research Site
City
South Brisbane
ZIP/Postal Code
4101
Country
New Zealand
Facility Name
Research Site
City
Tauranga
ZIP/Postal Code
3143
Country
New Zealand
Facility Name
Research Site
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Research Site
City
Cercado De Lima
ZIP/Postal Code
LIMA 1
Country
Peru
Facility Name
Research Site
City
Chancay
ZIP/Postal Code
15131
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
15033
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 01
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 21
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 27
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 32
Country
Peru
Facility Name
Research Site
City
Miraflores
ZIP/Postal Code
15046
Country
Peru
Facility Name
Research Site
City
Santa Beatriz
ZIP/Postal Code
LIMA 14
Country
Peru
Facility Name
Research Site
City
Lipa City
ZIP/Postal Code
4217
Country
Philippines
Facility Name
Research Site
City
Manila
Country
Philippines
Facility Name
Research Site
City
Pasig City
ZIP/Postal Code
1600
Country
Philippines
Facility Name
Research Site
City
Quezon City
ZIP/Postal Code
1109
Country
Philippines
Facility Name
Research Site
City
Quezon City
Country
Philippines
Facility Name
Research Site
City
Białystok
ZIP/Postal Code
15-044
Country
Poland
Facility Name
Research Site
City
Białystok
ZIP/Postal Code
15-430
Country
Poland
Facility Name
Research Site
City
Giżycko
ZIP/Postal Code
11-500
Country
Poland
Facility Name
Research Site
City
Kościan
ZIP/Postal Code
64-000
Country
Poland
Facility Name
Research Site
City
Kraków
ZIP/Postal Code
31-559
Country
Poland
Facility Name
Research Site
City
Lublin
ZIP/Postal Code
20-709
Country
Poland
Facility Name
Research Site
City
Mrągowo
ZIP/Postal Code
11-700
Country
Poland
Facility Name
Research Site
City
Ostrowiec Świętokrzyski
ZIP/Postal Code
27-400
Country
Poland
Facility Name
Research Site
City
Ostrów Wielkopolski
ZIP/Postal Code
63-400
Country
Poland
Facility Name
Research Site
City
Pabianice
ZIP/Postal Code
95-200
Country
Poland
Facility Name
Research Site
City
Pila
ZIP/Postal Code
64-920
Country
Poland
Facility Name
Research Site
City
Poznań
ZIP/Postal Code
60-685
Country
Poland
Facility Name
Research Site
City
Poznań
ZIP/Postal Code
60-693
Country
Poland
Facility Name
Research Site
City
Proszowice
ZIP/Postal Code
32-100
Country
Poland
Facility Name
Research Site
City
Rzeszów
ZIP/Postal Code
35-205
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-106
Country
Poland
Facility Name
Research Site
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
Research Site
City
Bragadiru
ZIP/Postal Code
077025
Country
Romania
Facility Name
Research Site
City
Brasov
ZIP/Postal Code
500051
Country
Romania
Facility Name
Research Site
City
Brasov
ZIP/Postal Code
500283
Country
Romania
Facility Name
Research Site
City
Bucharest
ZIP/Postal Code
030303
Country
Romania
Facility Name
Research Site
City
Constanta
ZIP/Postal Code
900002
Country
Romania
Facility Name
Research Site
City
Constanta
Country
Romania
Facility Name
Research Site
City
Deva
ZIP/Postal Code
330061
Country
Romania
Facility Name
Research Site
City
Iasi
ZIP/Postal Code
700115
Country
Romania
Facility Name
Research Site
City
Pitesti
ZIP/Postal Code
110084
Country
Romania
Facility Name
Research Site
City
Chelyabinsk
ZIP/Postal Code
454021
Country
Russian Federation
Facility Name
Research Site
City
Ekaterinburg
ZIP/Postal Code
620137
Country
Russian Federation
Facility Name
Research Site
City
Gatchina
ZIP/Postal Code
188300
Country
Russian Federation
Facility Name
Research Site
City
Ivanovo
ZIP/Postal Code
153005
Country
Russian Federation
Facility Name
Research Site
City
Izhevsk
ZIP/Postal Code
426035
Country
Russian Federation
Facility Name
Research Site
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Research Site
City
Kemerovo
ZIP/Postal Code
650000
Country
Russian Federation
Facility Name
Research Site
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation
Facility Name
Research Site
City
Kemerovo
ZIP/Postal Code
650066
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
109240
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
117630
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
121309
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
123182
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
142160
Country
Russian Federation
Facility Name
Research Site
City
Novosibirsk
ZIP/Postal Code
630008
Country
Russian Federation
Facility Name
Research Site
City
Novosibirsk
ZIP/Postal Code
630051
Country
Russian Federation
Facility Name
Research Site
City
Omsk
ZIP/Postal Code
644043
Country
Russian Federation
Facility Name
Research Site
City
Penza
ZIP/Postal Code
440067
Country
Russian Federation
Facility Name
Research Site
City
Perm
ZIP/Postal Code
614000
Country
Russian Federation
Facility Name
Research Site
City
Pskov
ZIP/Postal Code
180007
Country
Russian Federation
Facility Name
Research Site
City
Saint - Petersburg
ZIP/Postal Code
196211
Country
Russian Federation
Facility Name
Research Site
City
Saint - Petersburg
ZIP/Postal Code
196657
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
191144
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
194100
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
196240
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
197342
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
198260
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
198205
Country
Russian Federation
Facility Name
Research Site
City
Saratov
ZIP/Postal Code
410012
Country
Russian Federation
Facility Name
Research Site
City
Saratov
ZIP/Postal Code
410053
Country
Russian Federation
Facility Name
Research Site
City
St. Petersburg
ZIP/Postal Code
193231
Country
Russian Federation
Facility Name
Research Site
City
St. Petersburg
ZIP/Postal Code
196211
Country
Russian Federation
Facility Name
Research Site
City
St. Petersburg
ZIP/Postal Code
196247
Country
Russian Federation
Facility Name
Research Site
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Research Site
City
St.Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Research Site
City
Tomsk
ZIP/Postal Code
634050
Country
Russian Federation
Facility Name
Research Site
City
Tver
ZIP/Postal Code
170642
Country
Russian Federation
Facility Name
Research Site
City
Ufa
ZIP/Postal Code
450000
Country
Russian Federation
Facility Name
Research Site
City
Ulyanovsk
ZIP/Postal Code
432009
Country
Russian Federation
Facility Name
Research Site
City
Vladikavkaz
ZIP/Postal Code
362007
Country
Russian Federation
Facility Name
Research Site
City
Volgograd
ZIP/Postal Code
400131
Country
Russian Federation
Facility Name
Research Site
City
Vsevolozhsk
ZIP/Postal Code
188640
Country
Russian Federation
Facility Name
Research Site
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Research Site
City
Dhahran
ZIP/Postal Code
131932
Country
Saudi Arabia
Facility Name
Research Site
City
Jeddah
ZIP/Postal Code
21499
Country
Saudi Arabia
Facility Name
Research Site
City
Jeddah
ZIP/Postal Code
22252
Country
Saudi Arabia
Facility Name
Research Site
City
Riyadh
ZIP/Postal Code
12371
Country
Saudi Arabia
Facility Name
Research Site
City
Riyadh
ZIP/Postal Code
12713
Country
Saudi Arabia
Facility Name
Research Site
City
Kezmarok
ZIP/Postal Code
060 01
Country
Slovakia
Facility Name
Research Site
City
Komarno
ZIP/Postal Code
945 01
Country
Slovakia
Facility Name
Research Site
City
Kosice
ZIP/Postal Code
040 22
Country
Slovakia
Facility Name
Research Site
City
Kosice
ZIP/Postal Code
04022
Country
Slovakia
Facility Name
Research Site
City
Levice
ZIP/Postal Code
934 01
Country
Slovakia
Facility Name
Research Site
City
Liptovsky Mikulas
ZIP/Postal Code
031 01
Country
Slovakia
Facility Name
Research Site
City
Lucenec
ZIP/Postal Code
984 01
Country
Slovakia
Facility Name
Research Site
City
Nitra
ZIP/Postal Code
94901
Country
Slovakia
Facility Name
Research Site
City
Nove Zamky
ZIP/Postal Code
94001
Country
Slovakia
Facility Name
Research Site
City
Poprad
ZIP/Postal Code
058 01
Country
Slovakia
Facility Name
Research Site
City
Poprad
ZIP/Postal Code
05801
Country
Slovakia
Facility Name
Research Site
City
Rimavska Sobota
ZIP/Postal Code
979 01
Country
Slovakia
Facility Name
Research Site
City
Ruzomberok
ZIP/Postal Code
034 26
Country
Slovakia
Facility Name
Research Site
City
Skalica
ZIP/Postal Code
90901
Country
Slovakia
Facility Name
Research Site
City
Surany
ZIP/Postal Code
94201
Country
Slovakia
Facility Name
Research Site
City
Topolcany
ZIP/Postal Code
95501
Country
Slovakia
Facility Name
Research Site
City
Trebisov
ZIP/Postal Code
07701
Country
Slovakia
Facility Name
Research Site
City
Zilina
ZIP/Postal Code
01008
Country
Slovakia
Facility Name
Research Site
City
Zvolen
ZIP/Postal Code
96001
Country
Slovakia
Facility Name
Research Site
City
Bellville
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Research Site
City
Boksburg North
ZIP/Postal Code
1460
Country
South Africa
Facility Name
Research Site
City
Cape Town
ZIP/Postal Code
7570
Country
South Africa
Facility Name
Research Site
City
Cape Town
ZIP/Postal Code
7764
Country
South Africa
Facility Name
Research Site
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Research Site
City
Durban
ZIP/Postal Code
4037
Country
South Africa
Facility Name
Research Site
City
Durban
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Research Site
City
Durban
ZIP/Postal Code
4092
Country
South Africa
Facility Name
Research Site
City
Johannesburg
ZIP/Postal Code
2001
Country
South Africa
Facility Name
Research Site
City
Johannesburg
ZIP/Postal Code
2188
Country
South Africa
Facility Name
Research Site
City
Lenasia
ZIP/Postal Code
1829
Country
South Africa
Facility Name
Research Site
City
Mowbray
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Research Site
City
Panorama
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Research Site
City
Phoenix
ZIP/Postal Code
4068
Country
South Africa
Facility Name
Research Site
City
Verulam
ZIP/Postal Code
4345
Country
South Africa
Facility Name
Research Site
City
Alicante
ZIP/Postal Code
03004
Country
Spain
Facility Name
Research Site
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Research Site
City
Bilbao (Vizcaya)
ZIP/Postal Code
48013
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Research Site
City
Malaga
ZIP/Postal Code
29730
Country
Spain
Facility Name
Research Site
City
Marbella (Málaga)
ZIP/Postal Code
29603
Country
Spain
Facility Name
Research Site
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
Facility Name
Research Site
City
Terrassa (Barcelona)
ZIP/Postal Code
08227
Country
Spain
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Research Site
City
Borås
ZIP/Postal Code
506 30
Country
Sweden
Facility Name
Research Site
City
Lund
ZIP/Postal Code
222 21
Country
Sweden
Facility Name
Research Site
City
Malmo
ZIP/Postal Code
21152
Country
Sweden
Facility Name
Research Site
City
Stockholm
ZIP/Postal Code
114 46
Country
Sweden
Facility Name
Research Site
City
Värnamo
ZIP/Postal Code
33185
Country
Sweden
Facility Name
Research Site
City
Västra Frölunda
ZIP/Postal Code
42144
Country
Sweden
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10600
Country
Thailand
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Research Site
City
Chonburi
ZIP/Postal Code
20000
Country
Thailand
Facility Name
Research Site
City
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Research Site
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Research Site
City
Muang,
ZIP/Postal Code
55000
Country
Thailand
Facility Name
Research Site
City
Nonthaburi
ZIP/Postal Code
11000
Country
Thailand
Facility Name
Research Site
City
Pathumthani
ZIP/Postal Code
12120
Country
Thailand
Facility Name
Research Site
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Research Site
City
Chernihiv
ZIP/Postal Code
14034
Country
Ukraine
Facility Name
Research Site
City
Chernivtsi
ZIP/Postal Code
58000
Country
Ukraine
Facility Name
Research Site
City
Dnipro
ZIP/Postal Code
49074
Country
Ukraine
Facility Name
Research Site
City
Ivano-Frankivsk
ZIP/Postal Code
76012
Country
Ukraine
Facility Name
Research Site
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Research Site
City
Kharkiv
ZIP/Postal Code
61035
Country
Ukraine
Facility Name
Research Site
City
Kharkiv
ZIP/Postal Code
61039
Country
Ukraine
Facility Name
Research Site
City
Kharkiv
ZIP/Postal Code
61058
Country
Ukraine
Facility Name
Research Site
City
Kharkiv
ZIP/Postal Code
61075
Country
Ukraine
Facility Name
Research Site
City
Kherson
ZIP/Postal Code
73000
Country
Ukraine
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
02091
Country
Ukraine
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
03037
Country
Ukraine
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
Research Site
City
Lutsk
ZIP/Postal Code
43000
Country
Ukraine
Facility Name
Research Site
City
Lviv
ZIP/Postal Code
79066
Country
Ukraine
Facility Name
Research Site
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Research Site
City
Odessa
ZIP/Postal Code
65114
Country
Ukraine
Facility Name
Research Site
City
Ternopil
ZIP/Postal Code
46000
Country
Ukraine
Facility Name
Research Site
City
Uzhgorod
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
Research Site
City
Uzhgorod
ZIP/Postal Code
88009
Country
Ukraine
Facility Name
Research Site
City
Uzhgorod
ZIP/Postal Code
88014
Country
Ukraine
Facility Name
Research Site
City
Vinnytsia
ZIP/Postal Code
21001
Country
Ukraine
Facility Name
Research Site
City
Zaporizhzhya
ZIP/Postal Code
69063
Country
Ukraine
Facility Name
Research Site
City
Zaporizhzhya
ZIP/Postal Code
69068
Country
Ukraine
Facility Name
Research Site
City
Can Tho
ZIP/Postal Code
900000
Country
Vietnam
Facility Name
Research Site
City
Ha Noi
ZIP/Postal Code
100000
Country
Vietnam
Facility Name
Research Site
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Facility Name
Research Site
City
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam
Facility Name
Research Site
City
Hochiminh
ZIP/Postal Code
700000
Country
Vietnam
Facility Name
Research Site
City
Hue
ZIP/Postal Code
530000
Country
Vietnam
12. IPD Sharing Statement
Citations:
PubMed Identifier
33548020
Citation
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.
Results Reference
derived
PubMed Identifier
29768147
Citation
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.
Results Reference
derived
PubMed Identifier
28069068
Citation
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.
Results Reference
derived
PubMed Identifier
27912982
Citation
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.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=2649&filename=d589sc00003-revised-csp-edition-4_12Oct2016_Redacted_pdfa.pdf
Description
D589SC00003-revised-csp-edition-4_12Oct2016_Redacted_pdfa
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=2649&filename=D589SC00003-statistical-analysis-plan-edition-2_06SEP2017_pdfa.pdf
Description
D589SC00003-statistical-analysis-plan-edition-2_06SEP2017_pdfa
Learn more about this trial
A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma
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