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Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma (NAVIGATOR)

Primary Purpose

Asthma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Experimental: Tezepelumab

Placebo

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Uncontrolled Asthma, Severe Uncontrolled Asthma

Eligibility Criteria

12 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age. 12-80
Documented physician-diagnosed asthma for at least 12 months
Subjects who have received a physician-prescribed asthma controller medication with medium or high dose ICS for at least 12 months.
Documented treatment with a total daily dose of either medium or high dose ICS (≥ 500 µg fluticasone propionate dry powder formulation equivalent total daily dose) for at least 3 months.
At least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at least 3 months.
Morning pre-BD FEV1 <80% predicted normal (<90% for subjects 12-17 yrs)
Evidence of asthma as documented by either: Documented historical reversibility of FEV1 ≥12% and ≥200 mL in the previous 12 months OR Post-BD (albuterol/salbutamol) reversibility of FEV1 ≥12% and ≥200 mL during screening.
Documented history of at least 2 asthma exacerbation events within 12 months.
ACQ-6 score ≥1.5 at screening and on day of randomization

Exclusion Criteria:

Pulmonary disease other than asthma.
History of cancer.
History of a clinically significant infection.
Current smokers or subjects with smoking history ≥10 pack-years and subjects using vaping products, including electronic cigarettes.
History of chronic alcohol or drug abuse within 12 months.
Hepatitis B, C or HIV.
Pregnant or breastfeeding.
History of anaphylaxis following any biologic therapy.
Subject randomized in the current study or previous tezepelumab studies.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tezepelumab

Placebo

Arm Description

Tezepelumab: Tezepelumab subcutaneous injection

Placebo: Placebo subcutaneous injection

Outcomes

Primary Outcome Measures

Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma

The annual exacerbation rate is based on unadjudicated exacerbations reported by the investigator in the eCRF. The analysis is based on the primary population (Full Analysis Set)

Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma in Subjects With Baseline Eosinophils < 300 Cells/uL

The annual exacerbation rate is based on unadjudicated exacerbations reported by the investigator in the eCRF. This analysis is based on subjects with baseline eosinophils < 300 cells/uL

Secondary Outcome Measures

Mean Change From Baseline at Week 52 in Pre-dose/Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) (L) (Key Secondary Endpoint)

Mean change from baseline in FEV1 as compared to placebo at Week 52. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.

Mean Change From Baseline at Week 52 in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score (Key Secondary Endpoint)

Mean change from baseline in AQLQ(S)+12 as compared to placebo at Week 52. The AQLQ(S)+12 is a questionnaire that measures the health-related quality of life experienced by asthma subjects. The total score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment).

Mean Change From Baseline at Week 52 in Asthma Control Questionnaire-6(ACQ-6) (Key Secondary Endpoint)

Change from baseline in ACQ-6 as compared to placebo at Week 52. The ACQ-6 captures asthma symptoms and short-acting β2-agonist use via subject-report. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The ACQ-6 score is the mean of the responses.

Mean Change From Baseline at Week 52 in Asthma Symptom Diary (Key Secondary Endpoint)

Mean change from baseline at Week 52 in Asthma Symptom Diary. The Asthma Symptom Diary comprises of 10 items (5 items in the morning; 5 items in the evening). Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the daily diary. A daily ASD score is the mean of the 10 items. Responses for all 10 items are required to calculate the daily ASD score; otherwise, it is treated as missing. For the 7-day average asthma symptom score, scoring is done with no imputation using the mean of at least 4 of the 7 daily ASD scores as a mean weekly item score. The 7-day average ASD score ranges from 0 to 4, where 0 indicates no asthma symptoms.

Time to First Asthma Exacerbation

Time to first occurrence of asthma exacerbation post-randomisation, presented as number of subjects with at least one asthma exacerbation as reported by the investigator in the eCRF.

Mean Change From Baseline at Week 52 in Clinic Fractional Exhaled Nitric Oxide (FeNO) (Ppb)

Mean change from baseline at Study Week 52 in FeNO (ppb) measured at site

Mean Change From Baseline in Daily Rescue Medication Use (Weekly Means) at Week 52

Daily rescue medication use is defined as: Number of night inhaler puffs + 2 x [number of night nebulizer times] + number of daytime inhaler puffs + 2 x [number of day nebulizer times]. Weekly means are calculated using at least 4 of 7 days of daily rescue medication use.

Mean Change From Baseline in Work Productivity Loss Due to Asthma at Week 52

WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Work productivity loss is derived by sum of percentage of missed work due to asthma and product of percentage of actual working hours times degree of asthma affecting work productivity while working. Percentage of missed work due to asthma is calculated by number of hours missed work due to asthma divided by total number of hours missed work plus number of hours actually worked.

Mean Change From Baseline in Class Productivity Loss Due to Asthma at Week 52

WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Class productivity loss is derived by sum of percentage of missed class hours due to asthma and product of percentage of actual hours in class times degree of asthma affecting productivity while in class. Percentage of missed hours in class due to asthma is calculated by number of hours in class missed due to asthma divided by total number of hours in class missed plus number of hours actually in class.

Activity Impairment at Week 52

WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Activity impairment is the degree health affected regular activities (other than work or class) rated from 0 to 10, with 0 meaning no effect, divided by 10, and then expressed as a percentage.

Pharmacokinetics of Tezepelumab

Mean serum trough PK concentrations taken pre-dose at each visit

Mean Change From Baseline at Week 52 in EQ-5D-5L VAS

Mean change from baseline at Study Week 52 in EQ-5D-5L VAS. EQ-5D-5L visual analogue scale (VAS) allows subjects to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state.

Clinicians Global Impression of Change at Week 52

CGIC (Clinical global impression of change) is an overall evaluation of response to treatment, conducted by investigator using 7-point rating scale, ranging from 1 (very much improved), to 7 (very much worse)

Patients Global Impression of Change at Week 52

PGIC (Patient global impression of change) is an overall evaluation of response to treatment, conducted by the patient using 7-point rating scale, ranging from 1 (very much improved), to 7 (very much worse).

Patients Global Impression of Severity at Week 52

PGI-S (Patient global impression of severity) is an overall evaluation of patient's perception of overall symptom severity using a 6-point rating scale, ranging from 0 = No symptoms, 1=Very mild symptoms, 2=Mild symptoms, 3=Moderate symptoms, 4=Severe symptoms, 5=Very severe symptoms

Mean Change From Baseline at Week 52 in Blood Eosinophils (Cells/uL)

Mean change from baseline at Study Week 52 in blood eosinophils (cells/uL)

Mean Change From Baseline at Week 52 in Total Serum IgE (IU/mL)

Mean change from baseline at Study Week 52 in total serum IgE (IU/mL)

Number of Participants With Asthma Specific Healthcare Utilization Over 52 Weeks

Number of participants with asthma specific healthcare utilizations (e.g. unscheduled physician visits, unscheduled phone calls to physicians, use of other asthma medications) over 52 weeks

Mean Change From Baseline in Home Based Morning Peak Expiratory Flow (PEF) at Week 52 (Weekly Means)

Mean change from baseline in home based morning PEF (L/min) at Study Week 52. Home PEF testing will be performed by the subject in the morning upon awakening and in the evening at bedtime using an electronic, hand-held spirometer. Weekly means are calculated using at least 4 of the 7 days of PEF data.

Mean Change From Baseline in Home Based Evening Peak Expiratory Flow (PEF) at Week 52 (Weekly Means)

Mean change from baseline in home based evening PEF (L/min) at Study Week 52. Home PEF testing will be performed by the subject in the morning upon awakening and in the evening at bedtime using an electronic, hand-held spirometer. Weekly means are calculated using at least 4 of the 7 days of PEF data.

Mean Change From Baseline in Night Time Awakenings (Weekly Means) at Week 52

Mean change from baseline in night time awakenings due to asthma at Study Week 52. Night-time awakenings percentage defined as number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with data and multiplied by 100%. At least 4 out of 7 days of data is required to calculate a weekly mean.

Immunogenecity of Tezepelumab

Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at >=2 post baseline assessments (with >=16 weeks between the first and the last positive) or positive at last post baseline assessment. Transiently positive is defined as having at least one post baseline ADA positive assessment and not fulfilling the conditions of persistently positive. Treatment boosted ADA defined as baseline positive ADA that was boosted to a 4 fold or higher level following treatment. Treatment emergent ADA defined as sum of treatment induced ADA and treatment boosted ADA.

Proportion of Subjects Who Had no Asthma Exacerbations

The proportion of subjects who have no exacerbations is presented as the percentage of subjects with no exacerbations. This is defined as subjects who meet both the following criteria: (1) completed the 52 week treatment period and (2) did not report an exacerbation during this period.

Annual Asthma Exacerbation Rate Resulting in Emergency Room Visit or Hospitalisation

The annualized exacerbation rate is based on exacerbations reported by the investigator that are associated with an emergency room visit, urgent care visit, or a hospitalization (where urgent care visit was captured as an emergency room visit on the eCRF)

Proportion of Subjects With at Least One Asthma Exacerbation Associated With Emergency Room Visit or Hospitalisation

Proportion of subjects with at least one asthma exacerbation associated with emergency room visit or hospitalisation as recorded by the investigator in the CRF. This is presented as percentage of subjects with at least one asthma exacerbation associated with emergency room visit or hospitalisation.

Proportion of Subjects Who Had no Asthma Exacerbations Associated With Emergency Room or Hospitalisation

The proportion of subjects with no exacerbations is presented as percentage of subjects who meet both the following criteria: (1) completed the 52 week treatment period and (2) did not report an exacerbation associated with emergency room or hospitalisation during this period.

Full Information

NCT ID

NCT03347279

First Posted

November 9, 2017

Last Updated

October 29, 2021

Sponsor

AstraZeneca

Collaborators

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT03347279

Brief Title

Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma

Acronym

NAVIGATOR

Official Title

A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents With Severe Uncontrolled Asthma (NAVIGATOR)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

November 23, 2017 (Actual)

Primary Completion Date

September 8, 2020 (Actual)

Study Completion Date

November 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

Collaborators

Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asthma

Detailed Description

This is a multicentre, randomized, double-blind, placebo controlled, parallel group study designed to evaluate the efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma on medium to high-dose ICS and at least one additional asthma controller medication with or without OCS. Approximately 1060 subjects will be randomized globally. Subjects will receive tezepelumab, or placebo, administered via subcutaneous injection at the study site, over a 52-week treatment period. The study also includes a post-treatment follow-up period of 12 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Asthma, Uncontrolled Asthma, Severe Uncontrolled Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Subjects will be randomized in a 1:1 ratio to either tezepelumab or matching placebo both administered subcutaneously.

Masking

ParticipantCare ProviderInvestigator

Masking Description

Double-Blind

Allocation

Randomized

Enrollment

1061 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tezepelumab

Arm Type

Experimental

Arm Description

Tezepelumab: Tezepelumab subcutaneous injection

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo: Placebo subcutaneous injection

Intervention Type

Biological

Intervention Name(s)

Experimental: Tezepelumab

Other Intervention Name(s)

Tezepelumab

Intervention Description

Tezepelumab subcutaneous injection

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo subcutaneous injection

Primary Outcome Measure Information:

Title

Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma

Description

The annual exacerbation rate is based on unadjudicated exacerbations reported by the investigator in the eCRF. The analysis is based on the primary population (Full Analysis Set)

Time Frame

From randomisation to Study Week 52.

Title

Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma in Subjects With Baseline Eosinophils < 300 Cells/uL

Description

The annual exacerbation rate is based on unadjudicated exacerbations reported by the investigator in the eCRF. This analysis is based on subjects with baseline eosinophils < 300 cells/uL

Time Frame

From randomisation to Study Week 52.

Secondary Outcome Measure Information:

Title

Mean Change From Baseline at Week 52 in Pre-dose/Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) (L) (Key Secondary Endpoint)

Description

Mean change from baseline in FEV1 as compared to placebo at Week 52. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.

Time Frame

From randomisation to Study Week 52

Title

Mean Change From Baseline at Week 52 in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score (Key Secondary Endpoint)

Description

Time Frame

From randomisation to Study Week 52

Title

Mean Change From Baseline at Week 52 in Asthma Control Questionnaire-6(ACQ-6) (Key Secondary Endpoint)

Description

Time Frame

From randomisation to Study Week 52

Title

Mean Change From Baseline at Week 52 in Asthma Symptom Diary (Key Secondary Endpoint)

Description

Time Frame

From randomisation to Study Week 52

Title

Time to First Asthma Exacerbation

Description

Time to first occurrence of asthma exacerbation post-randomisation, presented as number of subjects with at least one asthma exacerbation as reported by the investigator in the eCRF.

Time Frame

From randomisation to Study Week 52

Title

Mean Change From Baseline at Week 52 in Clinic Fractional Exhaled Nitric Oxide (FeNO) (Ppb)

Description

Mean change from baseline at Study Week 52 in FeNO (ppb) measured at site

Time Frame

From randomisation to Study Week 52

Title

Mean Change From Baseline in Daily Rescue Medication Use (Weekly Means) at Week 52

Description

Time Frame

From randomisation to Study Week 52

Title

Mean Change From Baseline in Work Productivity Loss Due to Asthma at Week 52

Description

Time Frame

From randomisation to Study Week 52

Title

Mean Change From Baseline in Class Productivity Loss Due to Asthma at Week 52

Description

Time Frame

From randomisation to Study Week 52

Title

Activity Impairment at Week 52

Description

Time Frame

From randomisation to Study Week 52

Title

Pharmacokinetics of Tezepelumab

Description

Mean serum trough PK concentrations taken pre-dose at each visit

Time Frame

Pre-dose samples at Baseline, Week 4, Week 12, Week 24, Week 36, Week 52, Week 64

Title

Mean Change From Baseline at Week 52 in EQ-5D-5L VAS

Description

Time Frame

At Study Week 52

Title

Clinicians Global Impression of Change at Week 52

Description

Time Frame

From randomisation to Study Week 52

Title

Patients Global Impression of Change at Week 52

Description

Time Frame

From randomisation to Study Week 52

Title

Patients Global Impression of Severity at Week 52

Description

Time Frame

At Study Week 52

Title

Mean Change From Baseline at Week 52 in Blood Eosinophils (Cells/uL)

Description

Mean change from baseline at Study Week 52 in blood eosinophils (cells/uL)

Time Frame

From randomisation to Study Week 52

Title

Mean Change From Baseline at Week 52 in Total Serum IgE (IU/mL)

Description

Mean change from baseline at Study Week 52 in total serum IgE (IU/mL)

Time Frame

From randomisation to Study Week 52

Title

Number of Participants With Asthma Specific Healthcare Utilization Over 52 Weeks

Description

Number of participants with asthma specific healthcare utilizations (e.g. unscheduled physician visits, unscheduled phone calls to physicians, use of other asthma medications) over 52 weeks

Time Frame

From randomisation to Study Week 52

Title

Mean Change From Baseline in Home Based Morning Peak Expiratory Flow (PEF) at Week 52 (Weekly Means)

Description

Time Frame

From randomisation to Study Week 52

Title

Mean Change From Baseline in Home Based Evening Peak Expiratory Flow (PEF) at Week 52 (Weekly Means)

Description

Time Frame

From randomisation to Study Week 52

Title

Mean Change From Baseline in Night Time Awakenings (Weekly Means) at Week 52

Description

Time Frame

From randomisation to Study Week 52

Title

Immunogenecity of Tezepelumab

Description

Time Frame

Baseline, and from time of first dose at Week 0 to end of study at Week 64.

Title

Proportion of Subjects Who Had no Asthma Exacerbations

Description

Time Frame

From randomisation to Study Week 52

Title

Annual Asthma Exacerbation Rate Resulting in Emergency Room Visit or Hospitalisation

Description

Time Frame

From randomisation to Study Week 52

Title

Proportion of Subjects With at Least One Asthma Exacerbation Associated With Emergency Room Visit or Hospitalisation

Description

Time Frame

From randomisation to Study Week 52

Title

Proportion of Subjects Who Had no Asthma Exacerbations Associated With Emergency Room or Hospitalisation

Description

Time Frame

From randomisation to Study Week 52

Other Pre-specified Outcome Measures:

Title

Annual Asthma Exacerbation Rate Associated With Hospitalisations

Description

The annualized exacerbation rate is based on exacerbations reported by the investigator that are associated with hospitalization

Time Frame

From randomisation to Study Week 52

Title

Annual Asthma Exacerbation Rate Using Adjudicated Data

Description

The annualized exacerbation rate is based on exacerbations as defined for the primary endpoint, but any hospitalisation and ER visits which are adjudicated to be asthma related are added, and those adjudicated to not be asthma related are removed from analyses.

Time Frame

From randomisation to Study Week 52

Title

Annual Asthma Exacerbation Rate Associated With Emergency Room (ER) Visit or Hospitalisation Using Adjudicated Data

Description

The annualized exacerbation rate is based on exacerbations associated with hospitalisations or ER visits, where hospitalisation and ER visits adjudicated to be asthma related are added, and those adjudicated to not be asthma related are removed from analyses.

Time Frame

From randomisation to Study Week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age. 12-80 Documented physician-diagnosed asthma for at least 12 months Subjects who have received a physician-prescribed asthma controller medication with medium or high dose ICS for at least 12 months. Documented treatment with a total daily dose of either medium or high dose ICS (≥ 500 µg fluticasone propionate dry powder formulation equivalent total daily dose) for at least 3 months. At least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at least 3 months. Morning pre-BD FEV1 <80% predicted normal (<90% for subjects 12-17 yrs) Evidence of asthma as documented by either: Documented historical reversibility of FEV1 ≥12% and ≥200 mL in the previous 12 months OR Post-BD (albuterol/salbutamol) reversibility of FEV1 ≥12% and ≥200 mL during screening. Documented history of at least 2 asthma exacerbation events within 12 months. ACQ-6 score ≥1.5 at screening and on day of randomization Exclusion Criteria: Pulmonary disease other than asthma. History of cancer. History of a clinically significant infection. Current smokers or subjects with smoking history ≥10 pack-years and subjects using vaping products, including electronic cigarettes. History of chronic alcohol or drug abuse within 12 months. Hepatitis B, C or HIV. Pregnant or breastfeeding. History of anaphylaxis following any biologic therapy. Subject randomized in the current study or previous tezepelumab studies.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrew Menzies-Gow, MD

Organizational Affiliation

Royal Brompton Hospital, United Kingdom

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Dothan

State/Province

Alabama

ZIP/Postal Code

36303

Country

United States

Facility Name

Research Site

City

Foley

State/Province

Alabama

ZIP/Postal Code

36535

Country

United States

Facility Name

Research Site

City

Gilbert

State/Province

Arizona

ZIP/Postal Code

85234

Country

United States

Facility Name

Research Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85724

Country

United States

Facility Name

Research Site

City

Bakersfield

State/Province

California

ZIP/Postal Code

93301

Country

United States

Facility Name

Research Site

City

Encinitas

State/Province

California

ZIP/Postal Code

92024

Country

United States

Facility Name

Research Site

City

Huntington Beach

State/Province

California

ZIP/Postal Code

92647

Country

United States

Facility Name

Research Site

City

Long Beach

State/Province

California

ZIP/Postal Code

90808

Country

United States

Facility Name

Research Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90025

Country

United States

Facility Name

Research Site

City

Mission Viejo

State/Province

California

ZIP/Postal Code

92691

Country

United States

Facility Name

Research Site

City

Newport Beach

State/Province

California

ZIP/Postal Code

92663

Country

United States

Facility Name

Research Site

City

Northridge

State/Province

California

ZIP/Postal Code

91324

Country

United States

Facility Name

Research Site

City

Palm Desert

State/Province

California

ZIP/Postal Code

92260

Country

United States

Facility Name

Research Site

City

Rolling Hills Estates

State/Province

California

ZIP/Postal Code

90274

Country

United States

Facility Name

Research Site

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94598

Country

United States

Facility Name

Research Site

City

Westminster

State/Province

California

ZIP/Postal Code

92683

Country

United States

Facility Name

Research Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80206

Country

United States

Facility Name

Research Site

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

Facility Name

Research Site

City

Celebration

State/Province

Florida

ZIP/Postal Code

34747

Country

United States

Facility Name

Research Site

City

Kissimmee

State/Province

Florida

ZIP/Postal Code

34741

Country

United States

Facility Name

Research Site

City

Kissimmee

State/Province

Florida

ZIP/Postal Code

34744

Country

United States

Facility Name

Research Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32803

Country

United States

Facility Name

Research Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32825

Country

United States

Facility Name

Research Site

City

Panama City

State/Province

Florida

ZIP/Postal Code

32405

Country

United States

Facility Name

Research Site

City

Port Charlotte

State/Province

Florida

ZIP/Postal Code

33952

Country

United States

Facility Name

Research Site

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33704

Country

United States

Facility Name

Research Site

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33710

Country

United States

Facility Name

Research Site

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33713

Country

United States

Facility Name

Research Site

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34239

Country

United States

Facility Name

Research Site

City

Sebring

State/Province

Florida

ZIP/Postal Code

33870

Country

United States

Facility Name

Research Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33607

Country

United States

Facility Name

Research Site

City

Winter Park

State/Province

Florida

ZIP/Postal Code

32789

Country

United States

Facility Name

Research Site

City

Fayetteville

State/Province

Georgia

ZIP/Postal Code

30214

Country

United States

Facility Name

Research Site

City

Gainesville

State/Province

Georgia

ZIP/Postal Code

30501

Country

United States

Facility Name

Research Site

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31406

Country

United States

Facility Name

Research Site

City

Stockbridge

State/Province

Georgia

ZIP/Postal Code

30281

Country

United States

Facility Name

Research Site

City

Boise

State/Province

Idaho

ZIP/Postal Code

83706

Country

United States

Facility Name

Research Site

City

Michigan City

State/Province

Indiana

ZIP/Postal Code

46360

Country

United States

Facility Name

Research Site

City

Fort Mitchell

State/Province

Kentucky

ZIP/Postal Code

41017

Country

United States

Facility Name

Research Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40215

Country

United States

Facility Name

Research Site

City

Lake Charles

State/Province

Louisiana

ZIP/Postal Code

70601

Country

United States

Facility Name

Research Site

City

Zachary

State/Province

Louisiana

ZIP/Postal Code

70791

Country

United States

Facility Name

Research Site

City

White Marsh

State/Province

Maryland

ZIP/Postal Code

21162

Country

United States

Facility Name

Research Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Research Site

City

Fall River

State/Province

Massachusetts

ZIP/Postal Code

02721

Country

United States

Facility Name

Research Site

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Research Site

City

Flint

State/Province

Michigan

ZIP/Postal Code

48504

Country

United States

Facility Name

Research Site

City

Novi

State/Province

Michigan

ZIP/Postal Code

48375

Country

United States

Facility Name

Research Site

City

Port Huron

State/Province

Michigan

ZIP/Postal Code

48060

Country

United States

Facility Name

Research Site

City

Troy

State/Province

Michigan

ZIP/Postal Code

48085

Country

United States

Facility Name

Research Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63108

Country

United States

Facility Name

Research Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Research Site

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68505

Country

United States

Facility Name

Research Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89106

Country

United States

Facility Name

Research Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89119

Country

United States

Facility Name

Research Site

City

Northfield

State/Province

New Jersey

ZIP/Postal Code

08225

Country

United States

Facility Name

Research Site

City

Toms River

State/Province

New Jersey

ZIP/Postal Code

08755

Country

United States

Facility Name

Research Site

City

Bronx

State/Province

New York

ZIP/Postal Code

10459

Country

United States

Facility Name

Research Site

City

Bronx

State/Province

New York

ZIP/Postal Code

10465

Country

United States

Facility Name

Research Site

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11235

Country

United States

Facility Name

Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10022

Country

United States

Facility Name

Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Research Site

City

Valhalla

State/Province

New York

ZIP/Postal Code

10595

Country

United States

Facility Name

Research Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28277

Country

United States

Facility Name

Research Site

City

Gastonia

State/Province

North Carolina

ZIP/Postal Code

28054

Country

United States

Facility Name

Research Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27104

Country

United States

Facility Name

Research Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

Facility Name

Research Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45231

Country

United States

Facility Name

Research Site

City

Mayfield Heights

State/Province

Ohio

ZIP/Postal Code

44124

Country

United States

Facility Name

Research Site

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43608

Country

United States

Facility Name

Research Site

City

Edmond

State/Province

Oklahoma

ZIP/Postal Code

73034

Country

United States

Facility Name

Research Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73120

Country

United States

Facility Name

Research Site

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74136

Country

United States

Facility Name

Research Site

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504

Country

United States

Facility Name

Research Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15243

Country

United States

Facility Name

Research Site

City

Warwick

State/Province

Rhode Island

ZIP/Postal Code

02886

Country

United States

Facility Name

Research Site

City

Anderson

State/Province

South Carolina

ZIP/Postal Code

29621

Country

United States

Facility Name

Research Site

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29204

Country

United States

Facility Name

Research Site

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29607

Country

United States

Facility Name

Research Site

City

Allen

State/Province

Texas

ZIP/Postal Code

75013

Country

United States

Facility Name

Research Site

City

Amarillo

State/Province

Texas

ZIP/Postal Code

79106

Country

United States

Facility Name

Research Site

City

Boerne

State/Province

Texas

ZIP/Postal Code

78006

Country

United States

Facility Name

Research Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75225

Country

United States

Facility Name

Research Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Research Site

City

Lampasas

State/Province

Texas

ZIP/Postal Code

76550

Country

United States

Facility Name

Research Site

City

McAllen

State/Province

Texas

ZIP/Postal Code

78504

Country

United States

Facility Name

Research Site

City

Plano

State/Province

Texas

ZIP/Postal Code

75093

Country

United States

Facility Name

Research Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78251

Country

United States

Facility Name

Research Site

City

Manassas

State/Province

Virginia

ZIP/Postal Code

20110

Country

United States

Facility Name

Research Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23220

Country

United States

Facility Name

Research Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23235

Country

United States

Facility Name

Research Site

City

Cudahy

State/Province

Wisconsin

ZIP/Postal Code

53110

Country

United States

Facility Name

Research Site

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

Facility Name

Research Site

City

Buenos Aires

ZIP/Postal Code

C1414AIF

Country

Argentina

Facility Name

Research Site

City

Caba

ZIP/Postal Code

C1056ABJ

Country

Argentina

Facility Name

Research Site

City

Caba

ZIP/Postal Code

C1425BEN

Country

Argentina

Facility Name

Research Site

City

Ciudad de Buenos Aires

ZIP/Postal Code

1425

Country

Argentina

Facility Name

Research Site

City

Córdoba

ZIP/Postal Code

X5003DCE

Country

Argentina

Facility Name

Research Site

City

Mendoza

ZIP/Postal Code

5500

Country

Argentina

Facility Name

Research Site

City

Nueve de julio

ZIP/Postal Code

B6500EZL

Country

Argentina

Facility Name

Research Site

City

Quilmes

ZIP/Postal Code

B1878FNR

Country

Argentina

Facility Name

Research Site

City

Campbelltown

ZIP/Postal Code

2560

Country

Australia

Facility Name

Research Site

City

Kent Town

ZIP/Postal Code

5067

Country

Australia

Facility Name

Research Site

City

Melbourne

ZIP/Postal Code

3004

Country

Australia

Facility Name

Research Site

City

Nedlands

ZIP/Postal Code

6009

Country

Australia

Facility Name

Research Site

City

New Lambton

ZIP/Postal Code

2310

Country

Australia

Facility Name

Research Site

City

Spearwood

ZIP/Postal Code

6163

Country

Australia

Facility Name

Research Site

City

Westmead

ZIP/Postal Code

2145

Country

Australia

Facility Name

Research Site

City

Woolloongabba

ZIP/Postal Code

4102

Country

Australia

Facility Name

Research Site

City

Klagenfurt

ZIP/Postal Code

9020

Country

Austria

Facility Name

Research Site

City

Linz

ZIP/Postal Code

4020

Country

Austria

Facility Name

Research Site

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Research Site

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Research Site

City

Wien

ZIP/Postal Code

1130

Country

Austria

Facility Name

Research Site

City

Blumenau

ZIP/Postal Code

89030-101

Country

Brazil

Facility Name

Research Site

City

Botucatu

ZIP/Postal Code

18618-970

Country

Brazil

Facility Name

Research Site

City

Curitiba

ZIP/Postal Code

80060-900

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

90035-074

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

90619-900

Country

Brazil

Facility Name

Research Site

City

Porto Alegre

ZIP/Postal Code

91350-200

Country

Brazil

Facility Name

Research Site

City

Recife

ZIP/Postal Code

50070-550

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 Bernardo do Campo

ZIP/Postal Code

09750-420

Country

Brazil

Facility Name

Research Site

City

Sorocaba

ZIP/Postal Code

18040-425

Country

Brazil

Facility Name

Research Site

City

Vitória

ZIP/Postal Code

29055-450

Country

Brazil

Facility Name

Research Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4Z6

Country

Canada

Facility Name

Research Site

City

Sherwood Park

State/Province

Alberta

ZIP/Postal Code

T8L 0N2

Country

Canada

Facility Name

Research Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1M9

Country

Canada

Facility Name

Research Site

City

Ajax

State/Province

Ontario

ZIP/Postal Code

L1S 2J5

Country

Canada

Facility Name

Research Site

City

Burlington

State/Province

Ontario

ZIP/Postal Code

L7N 3V2

Country

Canada

Facility Name

Research Site

City

Mississauga

State/Province

Ontario

ZIP/Postal Code

L5A 3V4

Country

Canada

Facility Name

Research Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1G 6C6

Country

Canada

Facility Name

Research Site

City

Windsor

State/Province

Ontario

ZIP/Postal Code

N8X 1T3

Country

Canada

Facility Name

Research Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4J 1C5

Country

Canada

Facility Name

Research Site

City

St Charles Borromee

State/Province

Quebec

ZIP/Postal Code

J6E 2B4

Country

Canada

Facility Name

Research Site

City

Trois-Rivières

State/Province

Quebec

ZIP/Postal Code

G8T 7A1

Country

Canada

Facility Name

Research Site

City

Quebec

ZIP/Postal Code

G1G 3Y8

Country

Canada

Facility Name

Research Site

City

Brest Cedex

ZIP/Postal Code

29609

Country

France

Facility Name

Research Site

City

GRENOBLE Cedex 9

ZIP/Postal Code

38043

Country

France

Facility Name

Research Site

City

Le Kremlin Bicêtre

ZIP/Postal Code

94275

Country

France

Facility Name

Research Site

City

Lille Cedex

ZIP/Postal Code

59037

Country

France

Facility Name

Research Site

City

Lyon Cedex 04

ZIP/Postal Code

69317

Country

France

Facility Name

Research Site

City

MARSEILLE Cedex 20

ZIP/Postal Code

13015

Country

France

Facility Name

Research Site

City

Montpellier Cedex 5

ZIP/Postal Code

34295

Country

France

Facility Name

Research Site

City

Nantes Cedex 1

ZIP/Postal Code

44093

Country

France

Facility Name

Research Site

City

PARIS Cedex 12

ZIP/Postal Code

75571

Country

France

Facility Name

Research Site

City

Paris Cedex 18

ZIP/Postal Code

75877

Country

France

Facility Name

Research Site

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

Research Site

City

Pessac

ZIP/Postal Code

33604

Country

France

Facility Name

Research Site

City

Strasbourg Cedex

ZIP/Postal Code

67091

Country

France

Facility Name

Research Site

City

Toulouse CEDEX 09

ZIP/Postal Code

31059

Country

France

Facility Name

Research Site

City

Bamberg

ZIP/Postal Code

96049

Country

Germany

Facility Name

Research Site

City

Berlin

ZIP/Postal Code

10367

Country

Germany

Facility Name

Research Site

City

Berlin

ZIP/Postal Code

10717

Country

Germany

Facility Name

Research Site

City

Frankfurt am Main

ZIP/Postal Code

60596

Country

Germany

Facility Name

Research Site

City

Frankfurt

ZIP/Postal Code

60596

Country

Germany

Facility Name

Research Site

City

Hamburg

ZIP/Postal Code

20354

Country

Germany

Facility Name

Research Site

City

Hamburg

ZIP/Postal Code

22299

Country

Germany

Facility Name

Research Site

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Research Site

City

Hannover

ZIP/Postal Code

D-30173

Country

Germany

Facility Name

Research Site

City

Landsberg

ZIP/Postal Code

86899

Country

Germany

Facility Name

Research Site

City

Leipzig

ZIP/Postal Code

04103

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

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Research Site

City

Ashkelon

ZIP/Postal Code

7830604

Country

Israel

Facility Name

Research Site

City

Haifa

ZIP/Postal Code

34362

Country

Israel

Facility Name

Research Site

City

Jerusalem

ZIP/Postal Code

91031

Country

Israel

Facility Name

Research Site

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Research Site

City

Kfar Saba

ZIP/Postal Code

49281

Country

Israel

Facility Name

Research Site

City

Rehovot

ZIP/Postal Code

7661041

Country

Israel

Facility Name

Research Site

City

Bunkyo-ku

ZIP/Postal Code

113-8431

Country

Japan

Facility Name

Research Site

City

Chuo-ku

ZIP/Postal Code

103-0022

Country

Japan

Facility Name

Research Site

City

Chuo-ku

ZIP/Postal Code

103-0028

Country

Japan

Facility Name

Research Site

City

Chuo-ku

ZIP/Postal Code

104-0031

Country

Japan

Facility Name

Research Site

City

Edogawa-ku

ZIP/Postal Code

134-0083

Country

Japan

Facility Name

Research Site

City

Fujieda-shi

ZIP/Postal Code

426-8677

Country

Japan

Facility Name

Research Site

City

Fukuoka-shi

ZIP/Postal Code

810-0001

Country

Japan

Facility Name

Research Site

City

Fukuoka-shi

ZIP/Postal Code

811-1394

Country

Japan

Facility Name

Research Site

City

Fukuoka-shi

ZIP/Postal Code

815-8588

Country

Japan

Facility Name

Research Site

City

Habikino-shi

ZIP/Postal Code

583-8588

Country

Japan

Facility Name

Research Site

City

Hamamatsu-shi

ZIP/Postal Code

431-3192

Country

Japan

Facility Name

Research Site

City

Higashiibaraki-gun

ZIP/Postal Code

311-3193

Country

Japan

Facility Name

Research Site

City

Himeji-shi

ZIP/Postal Code

672-8064

Country

Japan

Facility Name

Research Site

City

Hitachi-shi

ZIP/Postal Code

317-0077

Country

Japan

Facility Name

Research Site

City

Itabashi-ku

ZIP/Postal Code

173-0003

Country

Japan

Facility Name

Research Site

City

Itabashi-ku

ZIP/Postal Code

173-8610

Country

Japan

Facility Name

Research Site

City

Kagoshima-shi

ZIP/Postal Code

890-0073

Country

Japan

Facility Name

Research Site

City

Kagoshima-shi

ZIP/Postal Code

890-8520

Country

Japan

Facility Name

Research Site

City

Kanazawa-shi

ZIP/Postal Code

920-8530

Country

Japan

Facility Name

Research Site

City

Kanazawa-shi

ZIP/Postal Code

920-8641

Country

Japan

Facility Name

Research Site

City

Kasuga-shi

ZIP/Postal Code

816-0813

Country

Japan

Facility Name

Research Site

City

Kishiwada-shi

ZIP/Postal Code

596-8501

Country

Japan

Facility Name

Research Site

City

Kitakyusyu

ZIP/Postal Code

802-0052

Country

Japan

Facility Name

Research Site

City

Koga-shi

ZIP/Postal Code

811-3195

Country

Japan

Facility Name

Research Site

City

Matsusaka-shi

ZIP/Postal Code

515-8544

Country

Japan

Facility Name

Research Site

City

Meguro-ku

ZIP/Postal Code

152-0021

Country

Japan

Facility Name

Research Site

City

Meguro-ku

ZIP/Postal Code

152-8621

Country

Japan

Facility Name

Research Site

City

Minato-ku

ZIP/Postal Code

105-0003

Country

Japan

Facility Name

Research Site

City

Minato-ku

ZIP/Postal Code

105-0004

Country

Japan

Facility Name

Research Site

City

Minato-ku

ZIP/Postal Code

108-0014

Country

Japan

Facility Name

Research Site

City

Mizunami-shi

ZIP/Postal Code

509-6134

Country

Japan

Facility Name

Research Site

City

Nagaoka-shi

ZIP/Postal Code

940-2085

Country

Japan

Facility Name

Research Site

City

Niigata-shi

ZIP/Postal Code

951-8520

Country

Japan

Facility Name

Research Site

City

Ogaki-shi

ZIP/Postal Code

503-8502

Country

Japan

Facility Name

Research Site

City

Ohota-ku

ZIP/Postal Code

145-0063

Country

Japan

Facility Name

Research Site

City

Omuta-shi

ZIP/Postal Code

837-0911

Country

Japan

Facility Name

Research Site

City

Sagamihara-shi

ZIP/Postal Code

228-0815

Country

Japan

Facility Name

Research Site

City

Sapporo-shi

ZIP/Postal Code

001-0901

Country

Japan

Facility Name

Research Site

City

Sapporo-shi

ZIP/Postal Code

064-0804

Country

Japan

Facility Name

Research Site

City

Setagaya-ku

ZIP/Postal Code

157-0072

Country

Japan

Facility Name

Research Site

City

Shibuya-ku

ZIP/Postal Code

150-0013

Country

Japan

Facility Name

Research Site

City

Shinagawa-ku

ZIP/Postal Code

140-8522

Country

Japan

Facility Name

Research Site

City

Shinagawa-ku

ZIP/Postal Code

142-8666

Country

Japan

Facility Name

Research Site

City

Shinjuku-ku

ZIP/Postal Code

162-8655

Country

Japan

Facility Name

Research Site

City

Shinjuku-ku

ZIP/Postal Code

162-8666

Country

Japan

Facility Name

Research Site

City

Sumida-ku

ZIP/Postal Code

130-0015

Country

Japan

Facility Name

Research Site

City

Takamatsu-shi

ZIP/Postal Code

761-8073

Country

Japan

Facility Name

Research Site

City

Toshima-ku

ZIP/Postal Code

170-0003

Country

Japan

Facility Name

Research Site

City

Toshima-ku

ZIP/Postal Code

171-0014

Country

Japan

Facility Name

Research Site

City

Ube

ZIP/Postal Code

755-8505

Country

Japan

Facility Name

Research Site

City

Yokkaichi-shi

ZIP/Postal Code

510-8567

Country

Japan

Facility Name

Research Site

City

Yokohama-shi

ZIP/Postal Code

223-0059

Country

Japan

Facility Name

Research Site

City

Yokohama-shi

ZIP/Postal Code

236-0004

Country

Japan

Facility Name

Research Site

City

Yokohama-shi

ZIP/Postal Code

236-0024

Country

Japan

Facility Name

Research Site

City

Yoshida-gun

ZIP/Postal Code

910-1193

Country

Japan

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

Daegu

ZIP/Postal Code

41404

Country

Korea, Republic of

Facility Name

Research Site

City

Daegu

ZIP/Postal Code

42415

Country

Korea, Republic of

Facility Name

Research Site

City

Jeju-si

ZIP/Postal Code

690-767

Country

Korea, Republic of

Facility Name

Research Site

City

Jeonju-si

ZIP/Postal Code

54907

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

02447

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

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

06351

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

08308

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

150-713

Country

Korea, Republic of

Facility Name

Research Site

City

Suwon-si

ZIP/Postal Code

16499

Country

Korea, Republic of

Facility Name

Research Site

City

Izhevsk

ZIP/Postal Code

426035

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

115093

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

115522

Country

Russian Federation

Facility Name

Research Site

City

St-Petersburg

ZIP/Postal Code

193231

Country

Russian Federation

Facility Name

Research Site

City

Jeddah

ZIP/Postal Code

21423

Country

Saudi Arabia

Facility Name

Research Site

City

Jeddah

ZIP/Postal Code

22252

Country

Saudi Arabia

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

4091

Country

South Africa

Facility Name

Research Site

City

Durban

ZIP/Postal Code

4092

Country

South Africa

Facility Name

Research Site

City

Durban

ZIP/Postal Code

4450

Country

South Africa

Facility Name

Research Site

City

Johannesburg

ZIP/Postal Code

1724

Country

South Africa

Facility Name

Research Site

City

Johannesburg

ZIP/Postal Code

1829

Country

South Africa

Facility Name

Research Site

City

Johannesburg

ZIP/Postal Code

2113

Country

South Africa

Facility Name

Research Site

City

Lenasia Ext8

ZIP/Postal Code

1820

Country

South Africa

Facility Name

Research Site

City

Middelburg

ZIP/Postal Code

1055

Country

South Africa

Facility Name

Research Site

City

Mowbray

ZIP/Postal Code

7700

Country

South Africa

Facility Name

Research Site

City

Parow

ZIP/Postal Code

7505

Country

South Africa

Facility Name

Research Site

City

Pretoria

ZIP/Postal Code

0157

Country

South Africa

Facility Name

Research Site

City

Umkomaas

ZIP/Postal Code

4170

Country

South Africa

Facility Name

Research Site

City

Witbank

ZIP/Postal Code

1035

Country

South Africa

Facility Name

Research Site

City

Hsinchu

ZIP/Postal Code

300

Country

Taiwan

Facility Name

Research Site

City

Kaohsiung City

ZIP/Postal Code

82445

Country

Taiwan

Facility Name

Research Site

City

Kaohsiung Hsien

ZIP/Postal Code

TAIWAN

Country

Taiwan

Facility Name

Research Site

City

Kaohsiung

ZIP/Postal Code

80756

Country

Taiwan

Facility Name

Research Site

City

Taichung

ZIP/Postal Code

40443

Country

Taiwan

Facility Name

Research Site

City

Tainan City

ZIP/Postal Code

70403

Country

Taiwan

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

220216

Country

Taiwan

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

235

Country

Taiwan

Facility Name

Research Site

City

Yilan

ZIP/Postal Code

260

Country

Taiwan

Facility Name

Research Site

City

Ivano-Frankivsk

ZIP/Postal Code

76018

Country

Ukraine

Facility Name

Research Site

City

Kharkiv Region

ZIP/Postal Code

61075

Country

Ukraine

Facility Name

Research Site

City

London

ZIP/Postal Code

SW3 6NP

Country

United Kingdom

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

Hanoi

ZIP/Postal Code

10000

Country

Vietnam

Facility Name

Research Site

City

Ho Chi Minh

ZIP/Postal Code

70000

Country

Vietnam

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing URL

https://astrazenecagroup-dt.pharmacm.com/DT/Home

Citations:

PubMed Identifier

33979488

Citation

Menzies-Gow A, Corren J, Bourdin A, Chupp G, Israel E, Wechsler ME, Brightling CE, Griffiths JM, Hellqvist A, Bowen K, Kaur P, Almqvist G, Ponnarambil S, Colice G. Tezepelumab in Adults and Adolescents with Severe, Uncontrolled Asthma. N Engl J Med. 2021 May 13;384(19):1800-1809. doi: 10.1056/NEJMoa2034975.

Results Reference

derived

PubMed Identifier

33050934

Citation

Menzies-Gow A, Colice G, Griffiths JM, Almqvist G, Ponnarambil S, Kaur P, Ruberto G, Bowen K, Hellqvist A, Mo M, Garcia Gil E. NAVIGATOR: a phase 3 multicentre, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma. Respir Res. 2020 Oct 13;21(1):266. doi: 10.1186/s12931-020-01526-6.

Results Reference

derived

Links:

URL

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5180C00007&attachmentIdentifier=103f6433-96f8-44c4-b837-d7315e83136d&fileName=d5180c00007-csp-v5-14.May.2020_Redacted.pdf&versionIdentifier=

Description

Related Info

URL

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5180C00007&attachmentIdentifier=3d32e500-6365-408d-bdb5-c145f83f1d2b&fileName=d5180c00007-sap-ed-4_22.Oct.2020_Redacted.pdf&versionIdentifier=

Description

Related Info

Learn more about this trial

Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma

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Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma (NAVIGATOR)

Asthma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

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