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A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma. (SYGMA1)

Primary Purpose

Asthma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

budesonide/formoterol 'as needed' + budesonide placebo bid

terbutaline 'as needed' + placebo budesonide bid

budesonide bid + terbutaline 'as needed'

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

12 Years - 130 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Symbicort "as needed"+placebo Pulmicort bid

terbutaline "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

terbutaline Turbuhaler 0.4 mg 'as needed' + placebo Pulmicort 200 μg Turbuhaler bid

Pulmicort 200 μg Turbuhaler bid + terbutaline 0.4 mg Turbuhaler 'as needed'

Outcomes

Primary Outcome Measures

'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.

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

Number of Participants Experiencing at Least One Moderate or Severe Asthma Exacerbation

A moderate exacerbation is defined as a deterioration of asthma requiring a change in treatment, i.e. initiation of prescribed additional ICS treatment to avoid progression of the worsening of asthma to a severe 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-dose Forced Expiratory Volume in 1 Second (FEV1)

Overall estimate of FEV1 (mL) pre-bronchodilator change from baseline. Baseline is the measurement at Visit 3 (prior to first dose of Investigational Product) from MMRM (mixed model repeated measures analysis).

Average Change From Baseline in Morning Peak Expiratory Flow (PEF)

Morning peak expiratory flow (eDiary) change from baseline over the randomised treatment period. Baseline is defined as the mean of all non-missing morning measurements during the last 10 days of the run-in period.

Average Change From Baseline in Evening PEF

Evening peak expiratory flow (eDiary) change from baseline during the randomised treatment period. Baseline is defined as the mean of all non-missing evening measurements during the last 10 days of the run-in period.

Average Change From Baseline in Number of Inhalations of 'as Needed' Medication.

'As needed' inhalations change from baseline over the randomised treatment period. Baseline is 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.

Average Change From Baseline in Asthma Symptom Score

Asthma symptom score (eDiary) change from baseline during the randomised treatment period. Symptom score is entered morning and evening by the patient on a 4-point scale from 0 to 3 with higher values indicating more severe symptoms. Asthma symptom score is then the sum of the day and night scores, which implies a range of scores from 0 - 6, with higher values indicating more severe symptoms. Baseline is defined as the mean of all non-missing measurements during the last 10 days of the run-in period.

Change From Baseline in the Percentage of Nighttime Awakenings Due to Asthma

Night-time awakenings (%) due to asthma change from baseline. Variable analysed is the proportion (%) of nights during the relevant period with night-time awakenings. Baseline refers to the last 10 nights of the run-in period.

Change From Baseline in Percentage of Symptom-free Days

Symptom-free days (%) change from baseline during the randomised treatment period.Variable analysed is the proportion (%) of symptom-free days during the relevant period. Baseline refers to the last 10 days of the run-in period.

Change From Baseline in Percentage of 'As Needed' Free Days

'As needed' free days (%) change from baseline during the randomised treatment period. An 'as needed' free day is defined as a day and night with no use of 'as needed' medication. Variable analysed is the proportion (%) of 'as needed' free days during the relevant period. Baseline refers to the last 10 days of the run-in period.

Change From Baseline in Percentage of Asthma Control Days

Asthma control days (%) change from baseline. An asthma control day is defined as the fulfilment of all of the following criteria; a day and night with no asthma symptoms, a night with no awakenings due to asthma symptoms and a day and night with no use of 'as needed' medication. Variable analysed is the proportion (%) of asthma control days during the randomised treatment period. Baseline refers to the last 10 days of the run-in period.

Number of Patients With Study Specific Asthma Related Discontinuation

Study specific asthma related discontinuation

Poorly Controlled Asthma Weeks

A poorly-controlled asthma week is defined as a week meeting any one of the following conditions: Two or more consecutive days with awakenings due to asthma on both nights; A recorded use of 'as needed' medication for symptom relief of at least 3 occasions per day, for at least 2 consecutive days; Additional systemic GCS treatment required for severe exacerbation. If there were sufficient data within a week available to confirm the week was not poorly-controlled, the week is labelled as 'does not meet criteria for poorly-controlled'.

Number of Participants Experiencing at Least One Occasion With Additional Steroids for Asthma

Additional steroids for asthma includes any additional inhaled and/or systemic glucocorticosteroids treatment due to asthma while in the randomised treatment period.

Average Change From Baseline in Asthma Control Questionnaire (ACQ-5)

Asthma Control Questionnaire 5-item version score change from baseline. 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.

Average Change From Baseline in Asthma Quality of Life Questionnaire; Standard Version (AQLQ(S))

Asthma Quality of Life Questionnaire Standardised Version (AQLQ (S) overall score change from baseline. 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.

Percentage of Controller Use Days

ICS controller use days (%) during the randomised treatment period is calculated as the cumulative number of 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 exacerbations and/or long term poor asthma control (all treatment groups), divided by the number of days in the randomised treatment period.

Annual Severe Asthma Exacerbation Rate

Severe asthma exacerbations over the randomised treatment period.

Annual Moderate or Severe Asthma Exacerbation Rate

Moderate or severe asthma exacerbations during the randomised treatment period.

Full Information

NCT ID

NCT02149199

First Posted

May 16, 2014

Last Updated

November 4, 2019

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT02149199

Brief Title

A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma.

Acronym

SYGMA1

Official 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.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

July 7, 2014 (Actual)

Primary Completion Date

August 2, 2017 (Actual)

Study Completion Date

August 2, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

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: 1) terbutaline Turbuhaler® 'as needed' and with 2) Pulmicort (budesonide) Turbuhaler® twice daily plus terbutaline Turbuhaler® 'as needed'.

Detailed Description

A 52-week, double-blind, randomised, multi-centre, parallel-group, Phase III 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 terbutaline Turbuhaler® 0.4 mg 'as needed' and 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

3850 (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

terbutaline "as needed"+placebo Pulmicort bid

Arm Type

Active Comparator

Arm Description

terbutaline Turbuhaler 0.4 mg 'as needed' + placebo Pulmicort 200 μg Turbuhaler 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)

terbutaline 'as needed' + placebo budesonide bid

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

budesonide 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

'Well-controlled Asthma Week' - a Derived Binary Variable (Yes/No)

Description

Time Frame

Weekly, up to 52 weeks

Secondary Outcome Measure Information:

Title

Number of Participants Experiencing at Least One Severe Asthma Exacerbation

Description

Time Frame

Day 1 up to 52 weeks

Title

Number of Participants Experiencing at Least One Moderate or Severe Asthma Exacerbation

Description

Time Frame

Day 1 up to 52 weeks

Title

Average Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1)

Description

Time Frame

Study weeks 0,4,16,28,40,52

Title

Average Change From Baseline in Morning Peak Expiratory Flow (PEF)

Description

Time Frame

up to 52 weeks

Title

Average Change From Baseline in Evening PEF

Description

Time Frame

up to 52 weeks

Title

Average Change From Baseline in Number of Inhalations of 'as Needed' Medication.

Description

Time Frame

up to 52 weeks

Title

Average Change From Baseline in Asthma Symptom Score

Description

Time Frame

up to 52 weeks

Title

Change From Baseline in the Percentage of Nighttime Awakenings Due to Asthma

Description

Time Frame

up to 52 weeks

Title

Change From Baseline in Percentage of Symptom-free Days

Description

Time Frame

up to 52 weeks

Title

Change From Baseline in Percentage of 'As Needed' Free Days

Description

Time Frame

up to 52 weeks

Title

Change From Baseline in Percentage of Asthma Control Days

Description

Time Frame

up to 52 weeks

Title

Number of Patients With Study Specific Asthma Related Discontinuation

Description

Study specific asthma related discontinuation

Time Frame

up to 52 weeks

Title

Poorly Controlled Asthma Weeks

Description

Time Frame

Weekly for up to 52 weeks

Title

Number of Participants Experiencing at Least One Occasion With Additional Steroids for Asthma

Description

Additional steroids for asthma includes any additional inhaled and/or systemic glucocorticosteroids treatment due to asthma while in the randomised treatment period.

Time Frame

Day 1 up to 52 weeks

Title

Average Change From Baseline in Asthma Control Questionnaire (ACQ-5)

Description

Time Frame

Study weeks 0,4,16,28,40,52

Title

Average Change From Baseline in Asthma Quality of Life Questionnaire; Standard Version (AQLQ(S))

Description

Time Frame

Study weeks 0,16,28,40,52

Title

Percentage of Controller Use Days

Description

Time Frame

up to 52 weeks

Title

Annual Severe Asthma Exacerbation Rate

Description

Severe asthma exacerbations over the randomised treatment period.

Time Frame

up to 52 weeks

Title

Annual Moderate or Severe Asthma Exacerbation Rate

Description

Moderate or severe asthma exacerbations during the randomised treatment period.

Time Frame

up to 52 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

130 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul M O'Byrne, MB, FRCP(C), FRSC

Organizational Affiliation

McMaster University, Hamilton, Canada

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Bedford Park

ZIP/Postal Code

5042

Country

Australia

Facility Name

Research Site

City

Concord

ZIP/Postal Code

2139

Country

Australia

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City

Maroubra

ZIP/Postal Code

2035

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Australia

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Murdoch

ZIP/Postal Code

6150

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Australia

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Wollongong

ZIP/Postal Code

2522

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Australia

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City

Alphaville

ZIP/Postal Code

06454-010

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Brazil

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City

Botucatu

ZIP/Postal Code

18618-970

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Brazil

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Porto Alegre

ZIP/Postal Code

90020-060

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Brazil

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Porto Alegre

ZIP/Postal Code

90470-340

Country

Brazil

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Porto Alegre

ZIP/Postal Code

90610-000

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Brazil

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City

Salvador

ZIP/Postal Code

41940-455

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Brazil

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Santo Andre

ZIP/Postal Code

09080-110

Country

Brazil

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Sao Paulo

ZIP/Postal Code

04020-060

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Brazil

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Sao Paulo

ZIP/Postal Code

04101-000

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Brazil

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City

Sorocaba

ZIP/Postal Code

18040-425

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Brazil

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City

Dupnitsa

ZIP/Postal Code

2600

Country

Bulgaria

Facility Name

Research Site

City

Gotse Delchev

ZIP/Postal Code

2900

Country

Bulgaria

Facility Name

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City

Kozloduy

ZIP/Postal Code

3320

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Bulgaria

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Pazardzhik

ZIP/Postal Code

4400

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Bulgaria

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Plovdiv

ZIP/Postal Code

4002

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Bulgaria

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Razgrad

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7200

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Bulgaria

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Roman

ZIP/Postal Code

3130

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Bulgaria

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Ruse

ZIP/Postal Code

7002

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Bulgaria

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Sandanski

ZIP/Postal Code

2800

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Bulgaria

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Sofia

ZIP/Postal Code

1000

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Bulgaria

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City

Sofia

ZIP/Postal Code

1152

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Bulgaria

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Sofia

ZIP/Postal Code

1431

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Bulgaria

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Sofia

ZIP/Postal Code

1606

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Bulgaria

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Sofia

ZIP/Postal Code

1618

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Bulgaria

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Varna

ZIP/Postal Code

9000

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Bulgaria

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Velingrad

ZIP/Postal Code

4600

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Bulgaria

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Vratsa

ZIP/Postal Code

3000

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Bulgaria

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Edmonton

State/Province

Alberta

ZIP/Postal Code

T5A 4L8

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Canada

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Sherwood Park

State/Province

Alberta

ZIP/Postal Code

T8L 0N2

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Canada

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Maple Ridge

State/Province

British Columbia

ZIP/Postal Code

V2X 2L5

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Canada

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North Vancouver

State/Province

British Columbia

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V7M 2H9

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Canada

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Vancouver

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British Columbia

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V5Z 1M9

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Canada

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Mount Pearl

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Newfoundland and Labrador

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A1N 1W7

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Canada

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St. John's

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Newfoundland and Labrador

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A1A 3R5

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Canada

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Ajax

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Ontario

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L1S 2J5

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Canada

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Burlington

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Ontario

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L7N 3V2

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Canada

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Cornwall

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Ontario

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K6H 4M4

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Canada

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Etobicoke

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Ontario

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M9W 4L6

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Canada

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Hamilton

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Ontario

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L8N 4A6

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Canada

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Kanata

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Ontario

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K2L 3C8

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Canada

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London

State/Province

Ontario

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N6H 0G6

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Canada

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Mississauga

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Ontario

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L5A 3V4

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Canada

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Newmarket

State/Province

Ontario

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L3Y 5G8

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Canada

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North York

State/Province

Ontario

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M3M 3E5

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Canada

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Ottawa

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Ontario

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K2H 8T5

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Canada

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Sarnia

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Ontario

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N7T 4X3

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Canada

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Toronto

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Ontario

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M9C 4Z5

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Canada

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Toronto

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Ontario

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M9V 4B4

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Canada

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Windsor

State/Province

Ontario

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N8X 2G1

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Canada

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Levis

State/Province

Quebec

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G6W 0M5

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Canada

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Montreal

State/Province

Quebec

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H1M 1B1

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Canada

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Montreal

State/Province

Quebec

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H3G 1L5

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Canada

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Montreal

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Quebec

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H4J 1C5

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Canada

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Pointe Claire

State/Province

Quebec

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H9R 4S3

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Canada

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Quebec City

State/Province

Quebec

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G1V 4W2

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Canada

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St Charles Borromee

State/Province

Quebec

ZIP/Postal Code

J6E 2B4

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Canada

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Trois Rivieres

State/Province

Quebec

ZIP/Postal Code

G8T 7A1

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Canada

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Victoriaville

State/Province

Quebec

ZIP/Postal Code

G6P 6P6

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Canada

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City

Quebec

ZIP/Postal Code

G1G 3Y8

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Canada

Facility Name

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City

Quebec

ZIP/Postal Code

G1W 4R4

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Canada

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City

Quebec

ZIP/Postal Code

G2J 0C4

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Canada

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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

7750495

Country

Chile

Facility Name

Research Site

City

Santiago

ZIP/Postal Code

7980378

Country

Chile

Facility Name

Research Site

City

Santiago

ZIP/Postal Code

8380453

Country

Chile

Facility Name

Research Site

City

Talcahuano

ZIP/Postal Code

4270918

Country

Chile

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Research Site

City

Beijing

ZIP/Postal Code

100043

Country

China

Facility Name

Research Site

City

Beijing

ZIP/Postal Code

100050

Country

China

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Research Site

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Changsha

ZIP/Postal Code

430033

Country

China

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Chengdu

ZIP/Postal Code

610041

Country

China

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Chengdu

ZIP/Postal Code

610083

Country

China

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Guangzhou

ZIP/Postal Code

510120

Country

China

Facility Name

Research Site

City

Guangzhou

ZIP/Postal Code

510515

Country

China

Facility Name

Research Site

City

Haikou

ZIP/Postal Code

570311

Country

China

Facility Name

Research Site

City

Hohhot

ZIP/Postal Code

010017

Country

China

Facility Name

Research Site

City

Nanchang

ZIP/Postal Code

330006

Country

China

Facility Name

Research Site

City

Shanghai

ZIP/Postal Code

200000

Country

China

Facility Name

Research Site

City

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Name

Research Site

City

Shanghai

ZIP/Postal Code

200040

Country

China

Facility Name

Research Site

City

Shanghai

ZIP/Postal Code

200120

Country

China

Facility Name

Research Site

City

Shanghai

ZIP/Postal Code

200240

Country

China

Facility Name

Research Site

City

Shanghai

ZIP/Postal Code

200433

Country

China

Facility Name

Research Site

City

Shenyang

ZIP/Postal Code

110015

Country

China

Facility Name

Research Site

City

Wenzhou

ZIP/Postal Code

325027

Country

China

Facility Name

Research Site

City

Wuhan

ZIP/Postal Code

CN-430030

Country

China

Facility Name

Research Site

City

Xi'an

ZIP/Postal Code

710004

Country

China

Facility Name

Research Site

City

Xi'an

ZIP/Postal Code

710038

Country

China

Facility Name

Research Site

City

Xiamen

ZIP/Postal Code

361004

Country

China

Facility Name

Research Site

City

Xuzhou

ZIP/Postal Code

221006

Country

China

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

1195

Country

Hungary

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1204

Country

Hungary

Facility Name

Research Site

City

Edelény

ZIP/Postal Code

3780

Country

Hungary

Facility Name

Research Site

City

Hajdúnánás

ZIP/Postal Code

4080

Country

Hungary

Facility Name

Research Site

City

Miskolc

ZIP/Postal Code

3529

Country

Hungary

Facility Name

Research Site

City

Monor

ZIP/Postal Code

2200

Country

Hungary

Facility Name

Research Site

City

Mátészalka

ZIP/Postal Code

4700

Country

Hungary

Facility Name

Research Site

City

Nyírbátor

ZIP/Postal Code

4300

Country

Hungary

Facility Name

Research Site

City

Nyíregyháza

ZIP/Postal Code

4420

Country

Hungary

Facility Name

Research Site

City

Pécs

ZIP/Postal Code

7626

Country

Hungary

Facility Name

Research Site

City

Pécs

ZIP/Postal Code

7635

Country

Hungary

Facility Name

Research Site

City

Szeged

ZIP/Postal Code

H-6722

Country

Hungary

Facility Name

Research Site

City

Bucheon-si

ZIP/Postal Code

14584

Country

Korea, Republic of

Facility Name

Research Site

City

Cheongju-si

ZIP/Postal Code

28644

Country

Korea, Republic of

Facility Name

Research Site

City

Cheongju-si

ZIP/Postal Code

362-804

Country

Korea, Republic of

Facility Name

Research Site

City

Incheon

ZIP/Postal Code

21431

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

03181

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

03722

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

07985

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Facility Name

Research Site

City

D.f.

ZIP/Postal Code

03020

Country

Mexico

Facility Name

Research Site

City

Durango

ZIP/Postal Code

43080

Country

Mexico

Facility Name

Research Site

City

Mexico

ZIP/Postal Code

06700

Country

Mexico

Facility Name

Research Site

City

Monterrey

ZIP/Postal Code

64461

Country

Mexico

Facility Name

Research Site

City

Morelia

ZIP/Postal Code

58070

Country

Mexico

Facility Name

Research Site

City

México

ZIP/Postal Code

04530

Country

Mexico

Facility Name

Research Site

City

México

ZIP/Postal Code

06720

Country

Mexico

Facility Name

Research Site

City

Villahermosa

ZIP/Postal Code

86035

Country

Mexico

Facility Name

Research Site

City

Cusco

ZIP/Postal Code

CUSCO 01

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

L18

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

L27

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

LIMA 1

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

LIMA 31

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

LIMA 41

Country

Peru

Facility Name

Research Site

City

Piura

Country

Peru

Facility Name

Research Site

City

Surco

ZIP/Postal Code

LIMA 33

Country

Peru

Facility Name

Research Site

City

Lipa City

ZIP/Postal Code

4217

Country

Philippines

Facility Name

Research Site

City

Manila

ZIP/Postal Code

1000

Country

Philippines

Facility Name

Research Site

City

Manila

ZIP/Postal Code

1003

Country

Philippines

Facility Name

Research Site

City

Pasig City

ZIP/Postal Code

1000

Country

Philippines

Facility Name

Research Site

City

Quezon City

ZIP/Postal Code

1101

Country

Philippines

Facility Name

Research Site

City

Białystok

ZIP/Postal Code

15-003

Country

Poland

Facility Name

Research Site

City

Białystok

ZIP/Postal Code

15-430

Country

Poland

Facility Name

Research Site

City

Elbląg

ZIP/Postal Code

82-300

Country

Poland

Facility Name

Research Site

City

Grodzisk Mazowiecki

ZIP/Postal Code

05-825

Country

Poland

Facility Name

Research Site

City

Grudziądz

ZIP/Postal Code

86-300

Country

Poland

Facility Name

Research Site

City

Kielce

ZIP/Postal Code

25-734

Country

Poland

Facility Name

Research Site

City

Kraków

ZIP/Postal Code

30-901

Country

Poland

Facility Name

Research Site

City

Kraków

ZIP/Postal Code

31-011

Country

Poland

Facility Name

Research Site

City

Kraków

ZIP/Postal Code

31-209

Country

Poland

Facility Name

Research Site

City

Kraków

ZIP/Postal Code

31-455

Country

Poland

Facility Name

Research Site

City

Poznań

ZIP/Postal Code

60-685

Country

Poland

Facility Name

Research Site

City

Poznań

ZIP/Postal Code

60-823

Country

Poland

Facility Name

Research Site

City

Rzeszów

ZIP/Postal Code

35-051

Country

Poland

Facility Name

Research Site

City

Rzeszów

ZIP/Postal Code

35-612

Country

Poland

Facility Name

Research Site

City

Skierniewice

ZIP/Postal Code

96-100

Country

Poland

Facility Name

Research Site

City

Strzelce Opolskie

ZIP/Postal Code

47-100

Country

Poland

Facility Name

Research Site

City

Szczecin

ZIP/Postal Code

70-111

Country

Poland

Facility Name

Research Site

City

Szczecin

ZIP/Postal Code

71-124

Country

Poland

Facility Name

Research Site

City

Słupca

ZIP/Postal Code

62-400

Country

Poland

Facility Name

Research Site

City

Tarnów

ZIP/Postal Code

33-100

Country

Poland

Facility Name

Research Site

City

Trzebnica

ZIP/Postal Code

55-100

Country

Poland

Facility Name

Research Site

City

Turek

ZIP/Postal Code

62-700

Country

Poland

Facility Name

Research Site

City

Zabrze

ZIP/Postal Code

41-800

Country

Poland

Facility Name

Research Site

City

Łódź

ZIP/Postal Code

90-141

Country

Poland

Facility Name

Research Site

City

Łódź

ZIP/Postal Code

90-203

Country

Poland

Facility Name

Research Site

City

Łódź

ZIP/Postal Code

91-103

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

Cluj-Napoca

ZIP/Postal Code

400371

Country

Romania

Facility Name

Research Site

City

Constanta

ZIP/Postal Code

900002

Country

Romania

Facility Name

Research Site

City

Pitesti

ZIP/Postal Code

110084

Country

Romania

Facility Name

Research Site

City

Timisoara

ZIP/Postal Code

300310

Country

Romania

Facility Name

Research Site

City

Chelyabinsk

ZIP/Postal Code

454021

Country

Russian Federation

Facility Name

Research Site

City

Ekaterinburg

ZIP/Postal Code

620039

Country

Russian Federation

Facility Name

Research Site

City

Ekaterinburg

ZIP/Postal Code

620109

Country

Russian Federation

Facility Name

Research Site

City

Ekaterinburg

ZIP/Postal Code

620219

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

Kazan

ZIP/Postal Code

420012

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

650099

Country

Russian Federation

Facility Name

Research Site

City

Krasnoyarsk

ZIP/Postal Code

660022

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

105077

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

119992

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

123995

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

127018

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

142160

Country

Russian Federation

Facility Name

Research Site

City

Nizhny Novgorod

ZIP/Postal Code

603126

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

630084

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

614056

Country

Russian Federation

Facility Name

Research Site

City

Perm

ZIP/Postal Code

6144090

Country

Russian Federation

Facility Name

Research Site

City

Petrozavodsk

ZIP/Postal Code

185019

Country

Russian Federation

Facility Name

Research Site

City

Pyatigorsk

ZIP/Postal Code

357538

Country

Russian Federation

Facility Name

Research Site

City

Ryazan

ZIP/Postal Code

390026

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

193312

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

196084

Country

Russian Federation

Facility Name

Research Site

City

Saint-Petersburg

ZIP/Postal Code

196084

Country

Russian Federation

Facility Name

Research Site

City

Saint-Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Research Site

City

Saratov

ZIP/Postal Code

410012

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

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

400001

Country

Russian Federation

Facility Name

Research Site

City

Volgograd

ZIP/Postal Code

400131

Country

Russian Federation

Facility Name

Research Site

City

Voronezh

ZIP/Postal Code

394066

Country

Russian Federation

Facility Name

Research Site

City

Yaroslavl

ZIP/Postal Code

150002

Country

Russian Federation

Facility Name

Research Site

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

Research Site

City

Boksburg North

ZIP/Postal Code

1460

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

4170

Country

South Africa

Facility Name

Research Site

City

Johannesburg

ZIP/Postal Code

1818

Country

South Africa

Facility Name

Research Site

City

Johannesburg

ZIP/Postal Code

2001

Country

South Africa

Facility Name

Research Site

City

Middelburg

ZIP/Postal Code

1055

Country

South Africa

Facility Name

Research Site

City

Queenswood

Country

South Africa

Facility Name

Research Site

City

Stanger

ZIP/Postal Code

4450

Country

South Africa

Facility Name

Research Site

City

Verulam

ZIP/Postal Code

4345

Country

South Africa

Facility Name

Research Site

City

Cherkasy

ZIP/Postal Code

18009

Country

Ukraine

Facility Name

Research Site

City

Dnipropetrovsk

ZIP/Postal Code

49074

Country

Ukraine

Facility Name

Research Site

City

Ivano-Frankivsk

ZIP/Postal Code

76012

Country

Ukraine

Facility Name

Research Site

City

Kharkiv

ZIP/Postal Code

61002

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

Kharkiv

ZIP/Postal Code

61093

Country

Ukraine

Facility Name

Research Site

City

Kyiv

ZIP/Postal Code

03049

Country

Ukraine

Facility Name

Research Site

City

Kyiv

ZIP/Postal Code

03680

Country

Ukraine

Facility Name

Research Site

City

Kyiv

Country

Ukraine

Facility Name

Research Site

City

Lutsk

ZIP/Postal Code

43000

Country

Ukraine

Facility Name

Research Site

City

Lutsk

ZIP/Postal Code

43024

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

Vinnytsia

ZIP/Postal Code

21018

Country

Ukraine

Facility Name

Research Site

City

Zaporizhzhya

ZIP/Postal Code

69068

Country

Ukraine

Facility Name

Research Site

City

Bath

ZIP/Postal Code

BA3 2UH

Country

United Kingdom

Facility Name

Research Site

City

Coventry

ZIP/Postal Code

CV6 4DD

Country

United Kingdom

Facility Name

Research Site

City

Leamington Spa

ZIP/Postal Code

CV32 4RA

Country

United Kingdom

Facility Name

Research Site

City

Mortimer Reading

ZIP/Postal Code

RG7 3SQ

Country

United Kingdom

Facility Name

Research Site

City

Trowbridge

ZIP/Postal Code

BA14 8QA

Country

United Kingdom

Facility Name

Research Site

City

Dong Nai

ZIP/Postal Code

810000

Country

Vietnam

Facility Name

Research Site

City

Hai Phong

ZIP/Postal Code

180000

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

Ho Chi Minh

Country

Vietnam

Facility Name

Research Site

City

Hochiminh

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

33010810

Citation

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.

Results Reference

derived

PubMed Identifier

29768149

Citation

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.

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=2648&filename=D589SC00001-statistical-analysis-plan-edition-4_29Sep2017_pdfa.pdf

Description

D589SC00001-statistical-analysis-plan-edition-4_29Sep2017_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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A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma. (SYGMA1)

Asthma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial