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Randomised Clinical Trial to Investigate Efficacy and Safety of Benralizumab 30 mg SC as an add-on Therapy in Uncontrolled Eosinophilic Asthma Patients Treated With Medium-dose ICS-LABA Compared to Conventional Escalation to High-dose ICS-LABA Treatment

NCT ID: NCT06750289

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-28

Study Completion Date

2027-11-02

Brief Summary

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This study evaluates the efficacy and safety of benralizumab as an add-on therapy in uncontrolled eosinophilic asthma participants treated with medium-dose ICS-LABA compared to the conventional treatment step of escalation of inhaled therapy to high-dose ICS-LABA.

Detailed Description

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This is a randomized, double-blind, active-controlled, parallel group global study designed to investigate the efficacy and safety of adding fixed-dose benralizumab (30 mg), administered subcutaneously (SC) every 4 weeks for the first 3 doses and then every 8 weeks for participants with a history of eosinophilic asthma, who remain uncontrolled on medium-dose Inhaled corticosteroid-Long-acting β2-agonists (ICS-LABA) with or without other asthma controller(s) (with the exception of oral corticosteroids), compared to the conventional treatment step of escalation of inhaled therapy to high-dose ICS-LABA plus placebo (benralizumab).

Conditions

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Eosinophilic Asthma

Keywords

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FASENRA, Eosinophilic Asthma; Benralizumab, Medium-Dose Inhaled Corticosteroid, Long-acting β2-Agonist

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomised 1:1 to one of the following arms:

* Medium-dose ICS-LABA + benralizumab
* High-dose ICS-LABA + placebo (benralizumab)
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Benralizumab and placebo will be supplied in identical Accessorised pre-filled syringe (APFS). Medium and high dose ICS-LABA will be supplied in identical inhalers, as appropriate for US and ex-US markets, and the maximum daily dose is the same for the 2 Investigational products (IPs) (2 doses/day).

Participants are not aware of the dose levels to which they are assigned. The Interactive Response Technology / Randomisation and Trial Supply Management (IRT/RTSM) will provide to the investigator(s) or pharmacist(s) the kit identification number to be allocated to the participant at the dispensing visit.

Routines for this will be described in the IRT/RTSM user manual that will be provided to each centre.

Study Groups

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Medium-dose ICS-LABA + benralizumab

Participants will be randomised 1:1 to one of the 2 study arms. Participants will receive up to 7 SC injections during study, with the first 3 doses administered every 4 weeks and then subsequent doses every 8 weeks.

Group Type ACTIVE_COMPARATOR

ICS-LABA

Intervention Type COMBINATION_PRODUCT

ICS-LABA inhalation

benralizumab

Intervention Type COMBINATION_PRODUCT

Benralizumab. SC injection.

High-dose ICS-LABA + placebo

Participants will be randomised 1:1 to one of the 2 study arms. Participants will receive up to 7 SC injections during study, with the first 3 doses administered every 4 weeks and then subsequent doses every 8 weeks.

Group Type ACTIVE_COMPARATOR

ICS-LABA

Intervention Type COMBINATION_PRODUCT

ICS-LABA inhalation

Placebo for Benralizumab

Intervention Type COMBINATION_PRODUCT

Placebo for Benralizumab (aka, "placebo"). SC injection.

Interventions

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ICS-LABA

ICS-LABA inhalation

Intervention Type COMBINATION_PRODUCT

benralizumab

Benralizumab. SC injection.

Intervention Type COMBINATION_PRODUCT

Placebo for Benralizumab

Placebo for Benralizumab (aka, "placebo"). SC injection.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

* Written informed consent
* Participant must be 12 to 75 years of age
* Documented history of physician-diagnosed asthma requiring treatment with at least medium-dose ICS (\> 250 μg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit (V) 1.
* Documented treatment with medium-dose ICS and LABA for at least 3 months prior to Visit 1 with or without additional asthma controllers (excluding oral corticosteroids).
* Weight of ≥ 35 kg.
* Pre-Bronchodilator (BD) Forced expiratory volume in 1 second (FEV1) of ≤ 90% predicted
* Documented at least 2 asthma exacerbations in the 12 months prior to the date of informed consent.
* ACQ-6 score ≥ 1.5 at Visit 1, plus at least once in the run-in period (from V2 to V3) and at V3.
* Evidence of asthma as documented by excessive variability in lung function, as defined in the protocol.
* Peripheral blood eosinophil count of ≥ 150 cells/μL, as defined in the protocol.
* At least 70% compliance with usual asthma controller ICS-LABA during run-in period (from Visit 2 to Visit 3) based on asthma daily diary.

Exclusion Criteria

* Important pulmonary disease other than asthma at the discretion of the investigator, or ever been diagnosed with pulmonary or systemic disease, other than asthma, which are associated with elevated peripheral eosinophil counts.
* Asthma exacerbation requiring use of Systemic corticosteroids (SCS), or acute upper/lower respiratory infection that requires antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period
* Any unstable disorder that in the opinion of the investigator could affect the study according to the study protocol.
* Clinically significant chronic or ongoing active infections requiring systemic treatment (at investigator's discretion)
* Concurrent participation in another clinical study with an IP or a post-authorisation safety study.
* History of alcohol or drug abuse within 12 months prior to the date informed consent is obtained.
* Current smokers or former smokers with a smoking history ≥ 10 pack-years. Former smokers must have stopped for at least 6 months prior to Visit 1 to be eligible.
Minimum Eligible Age

12 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Chandler, Arizona, United States

Site Status WITHDRAWN

Research Site

Sun City, Arizona, United States

Site Status NOT_YET_RECRUITING

Research Site

Tucson, Arizona, United States

Site Status RECRUITING

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Bakersfield, California, United States

Site Status NOT_YET_RECRUITING

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Inglewood, California, United States

Site Status RECRUITING

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Newport Beach, California, United States

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Pasadena, California, United States

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Denver, Colorado, United States

Site Status NOT_YET_RECRUITING

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Cape Coral, Florida, United States

Site Status RECRUITING

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Lauderdale Lakes, Florida, United States

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Leesburg, Florida, United States

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Miami, Florida, United States

Site Status NOT_YET_RECRUITING

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Miami, Florida, United States

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Orlando, Florida, United States

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Tampa, Florida, United States

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Winter Park, Florida, United States

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Ann Arbor, Michigan, United States

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Henderson, Nevada, United States

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Northfield, New Jersey, United States

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New Hyde Park, New York, United States

Site Status RECRUITING

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The Bronx, New York, United States

Site Status NOT_YET_RECRUITING

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Oklahoma City, Oklahoma, United States

Site Status WITHDRAWN

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Oklahoma City, Oklahoma, United States

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DuBois, Pennsylvania, United States

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Research Site

Warwick, Rhode Island, United States

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Greenville, South Carolina, United States

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McKinney, Texas, United States

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San Antonio, Texas, United States

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Plovdiv, , Bulgaria

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Rousse, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Stara Zagora, , Bulgaria

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Edmonton, Alberta, Canada

Site Status WITHDRAWN

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Kamloops, British Columbia, Canada

Site Status RECRUITING

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Vancouver, British Columbia, Canada

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Ajax, Ontario, Canada

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Toronto, Ontario, Canada

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Windsor, Ontario, Canada

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Québec, Quebec, Canada

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Sainte-Foy, Quebec, Canada

Site Status RECRUITING

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Beijing, , China

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Beijing, , China

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Beijing, , China

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Changsha, , China

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Chongqing, , China

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Fuzhou, , China

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Fuzhou, , China

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Fuzhou, , China

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Guangzhou, , China

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Guangzhou, , China

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Hangzhou, , China

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Hangzhou, , China

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Hefei, , China

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Huizhou, , China

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Jinan, , China

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Qinhuangdao, , China

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Shanghai, , China

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Shanghai, , China

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Wenzhou, , China

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Wuhan, , China

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Xuzhou, , China

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Yinchuan, , China

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Zhengzhou, , China

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Bayonne, , France

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Créteil, , France

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La Tronche, , France

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Lyon, , France

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Montpellier, , France

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Pessac, , France

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Suresnes, , France

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Toulouse, , France

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Villeurbanne, , France

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Berlin, , Germany

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Berlin, , Germany

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Bonn, , Germany

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Cottbus, , Germany

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Delitzsch, , Germany

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Research Site

Geesthacht, , Germany

Site Status RECRUITING

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Landsberg, , Germany

Site Status NOT_YET_RECRUITING

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Lübeck, , Germany

Site Status RECRUITING

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Mönchengladbach, , Germany

Site Status NOT_YET_RECRUITING

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München, , Germany

Site Status NOT_YET_RECRUITING

Research Site

München-Pasing, , Germany

Site Status NOT_YET_RECRUITING

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Neu-Isenburg, , Germany

Site Status NOT_YET_RECRUITING

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Wiesbaden, , Germany

Site Status RECRUITING

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Witten, , Germany

Site Status NOT_YET_RECRUITING

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Hong Kong, , Hong Kong

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Research Site

Pok Fu Lam, , Hong Kong

Site Status RECRUITING

Research Site

Shatin, , Hong Kong

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Ballinasloe, , Ireland

Site Status RECRUITING

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Cork, , Ireland

Site Status NOT_YET_RECRUITING

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Dublin, , Ireland

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Moneymore, , Ireland

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Bari, , Italy

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Bergamo, , Italy

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Brescia, , Italy

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Cagliari, , Italy

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Catanzaro, , Italy

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Genoa, , Italy

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Milan, , Italy

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Modena, , Italy

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Montebelluna, , Italy

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Napoli, , Italy

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Roma, , Italy

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Roma, , Italy

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Rozzano, , Italy

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Verona, , Italy

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Lørenskog, , Norway

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Alcorcón, , Spain

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Alzira (Valencia), , Spain

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Badalona, , Spain

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Barakaldo, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Burgos, , Spain

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Cáceres, , Spain

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Granada, , Spain

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Jerez de la Frontera, , Spain

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Lugo, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Marbella, , Spain

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Marbella, , Spain

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Málaga, , Spain

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Mérida, , Spain

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Palma de Mallorca, , Spain

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Santander, , Spain

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Research Site

Aarau, , Switzerland

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Basel, , Switzerland

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Lausanne, , Switzerland

Site Status RECRUITING

Research Site

Sankt Gallen, , Switzerland

Site Status RECRUITING

Research Site

Sion, , Switzerland

Site Status RECRUITING

Research Site

Belfast, , United Kingdom

Site Status NOT_YET_RECRUITING

Research Site

Birmingham, , United Kingdom

Site Status RECRUITING

Research Site

Bradford, , United Kingdom

Site Status RECRUITING

Research Site

Bristol, , United Kingdom

Site Status RECRUITING

Research Site

Chorley, , United Kingdom

Site Status NOT_YET_RECRUITING

Research Site

Leeds, , United Kingdom

Site Status RECRUITING

Research Site

Nottingham, , United Kingdom

Site Status WITHDRAWN

Research Site

Portsmouth, , United Kingdom

Site Status WITHDRAWN

Countries

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United States Bulgaria Canada China France Germany Hong Kong Ireland Italy Norway Spain Switzerland United Kingdom

Central Contacts

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AstraZeneca Clinical Study Information Center

Role: CONTACT

Phone: 1-877-240-9479

Email: [email protected]

Other Identifiers

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D3250C00101

Identifier Type: -

Identifier Source: org_study_id