A Study to Investigate the Effect on Lung Function of BDA Formulated With a Next Generation Propellant Compared With an Approved Asthma Treatment (BDA With HFA Propellant) in Participants With Asthma

NCT06502366 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: D6933C00002
• Study Type: interventional
• Target: 422
• Locations: 6 countries
• Sites: 128

Brief Summary

The purpose of this study is to assess the PD equivalence of the approved asthma combination therapy, BDA, delivered using the proposed replacement propellant HFO compared with BDA delivered using the currently approved propellant HFA in participants with asthma.

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

• Change from baseline in peak FEV1 in 0-60 minutes after dosing at Day 29

  To assess the equivalence of BDA MDI HFO relative to BDA MDI HFA on lung function in participants with asthma.

  Change from baseline at Day 29

• Change from baseline in peak FEV1 in 0-60 minutes after dosing at Day 29

  To demonstrate assay sensitivity via superiority of BDA MDI HFA relative to placebo MDI HFA on lung function in participants with asthma

  Change from baseline at Day 29

Secondary Outcomes (2)

• Change from baseline in morning pre-dose trough FEV1

  Change from baseline at Day 29

• Change from baseline in morning pre-dose trough FEV1

  Change from baseline at Day 29

Study Arms (3)

BDA MDI HFO

ACTIVE COMPARATOR

160/180 µg Budesonide/albuterol pressurized inhalation suspension, HFO

Drug: BDA MDI HFO 160/180 μg

BDA MDI HFA

ACTIVE COMPARATOR

160/180 µg Budesonide/albuterol pressurized inhalation suspension, HFA

Drug: BDA MDI HFA 160/180 μg

Placebo MDI HFA

PLACEBO COMPARATOR

Placebo pressurized inhalation suspension, HFA

Drug: Placebo MDI HFA

Interventions

Placebo MDI HFA DRUG

Placebo pressurized inhalation suspension, HFA

Placebo MDI HFA

BDA MDI HFO 160/180 μg DRUG

Budesonide/albuterol pressurized inhalation suspension, HFO

BDA MDI HFO

BDA MDI HFA 160/180 μg DRUG

Budesonide/albuterol pressurized inhalation suspension, HFA

BDA MDI HFA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be ≥ 18 years of age at the time of signing the ICF.
• Participants who have physician diagnosed asthma as defined by GINA for at least 12 months prior to Visit 1.
• Eligible participants are on either a) no daily inhaled maintenance therapy or b) daily inhaled maintenance therapy with low-dose ICS or low-dose ICS-LABA. Participants who are on low-dose ICS maintenance therapy are required to be stable on therapy for a minimum of 3 months prior to Visit 1; participants using low-dose ICSLABA maintenance regimens are required to be stable on therapy for a minimum of 6 months prior to Visit 1.
• Participants with a pre-bronchodilator FEV1 of ≥ 60% and \< 90% predicted normal at Visit 1 or Visit 1a.
• Participants with a pre-dose FEV1 of ≥ 60% and \< 90% predicted normal at Visit 2 that is within ± 20% of their Visit 1 pre-bronchodilator FEV1.
• Participants who demonstrate bronchodilator responsiveness defined as a \> 12% and \> 200 mL increase in FEV1 relative to baseline following administration of study provided SABA at Visit 1 or Visit 1a.
• Participants able to demonstrate acceptable spirometry performance as defined by the acceptability and repeatability criteria in the ATS/ERS Standardization of Spirometry 2019 update
• Participants who are willing and, in the opinion of the investigator, able to adjust current asthma therapy, as required by the protocol.
• Participants with a body mass index \< 40 kg/m2.
• Females must not be of childbearing potential or, if of childbearing potential, using a form of birth control

You may not qualify if:

• Confirmed or suspected diagnosis of COPD or clinically significant non-asthma airway/lung disease.
• Systemic corticosteroid use (eg, prednisone for 3 or more days or a single depo-injectable dose of corticosteroids) for any respiratory, immune, or allergy-attributed disease within 6 months prior to Visit 1.
• An upper respiratory infection requiring antibiotic treatment that is not resolved within 7 days prior to Visit 1.
• A lower respiratory infection in the 4 weeks prior to Visit 1.
• Life-threatening asthma defined as any history of significant asthma episode(s) requiring admission to an intensive care unit, positive pressure ventilation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s) within 5 years of Visit 1.
• Hospitalization due to asthma within 12 months or systemic corticosteroid usage (eg, prednisone for 3 or more days or a single depo-injectable dose of corticosteroids) for asthma within 6 months prior to Visit 1.
• A severe asthma exacerbation during the run-in period
• An ePRO device alert during the run-in period with investigator-confirmed worsening asthma symptoms
• Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular (eg, congestive heart failure, known aortic aneurysm, clinically significant cardiac arrhythmia, coronary heart disease), hepatic, renal, hematological, neuropsychological, endocrine (eg, uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison's disease, Cushing's syndrome), or gastrointestinal (eg, poorly controlled peptic ulcer, gastroesophageal reflux disease) disorders. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the participant at risk through study participation or that could affect the efficacy or safety analyses if the disease/condition exacerbated during the study.
• Unresectable cancer that has not been in complete remission for at least 5 years prior to Visit 1
• Hospitalization for psychiatric disorder or attempted suicide within 1 year of Visit 1.
• Known history of drug or alcohol abuse within 12 months of Visit 1 or known abuse at any time during the study.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (128)

Research Site

Mobile, Alabama, 36608, United States

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Sheffield, Alabama, 35660, United States

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Phoenix, Arizona, 85018, United States

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Little Rock, Arkansas, 72205, United States

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Encinitas, California, 92024, United States

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Fullerton, California, 92835, United States

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Gardena, California, 90247, United States

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Huntington Beach, California, 92647, United States

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La Mesa, California, 91942, United States

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Los Angeles, California, 90025, United States

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Los Angeles, California, 90048, United States

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Sacramento, California, 95821, United States

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San Bernardino, California, 92408, United States

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San Diego, California, 92123, United States

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San Jose, California, 95117, United States

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Santa Ana, California, 92704, United States

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Stockton, California, 95207, United States

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Westminster, California, 92683, United States

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Englewood, Colorado, 80110, United States

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Wheat Ridge, Colorado, 80033, United States

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Washington D.C., District of Columbia, 20016, United States

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Boynton Beach, Florida, 33435, United States

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Miami, Florida, 33175, United States

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Tallahassee, Florida, 32308, United States

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Tampa, Florida, 33607, United States

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Atlanta, Georgia, 30328, United States

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Rincon, Georgia, 31326, United States

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Savannah, Georgia, 31406, United States

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Meridian, Idaho, 83646, United States

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River Forest, Illinois, 60305, United States

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Evansville, Indiana, 47715, United States

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Valparaiso, Indiana, 46383, United States

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Sioux City, Iowa, 51106, United States

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Louisville, Kentucky, 40217, United States

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Lafayette, Louisiana, 70508, United States

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New Orleans, Louisiana, 70119, United States

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White Marsh, Maryland, 21162, United States

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Flint, Michigan, 48504, United States

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Columbia, Missouri, 65203, United States

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St Louis, Missouri, 63141, United States

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Omaha, Nebraska, 68134, United States

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Monticello, New York, 12701, United States

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New York, New York, 10036, United States

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Watertown, New York, 13601, United States

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Charlotte, North Carolina, 28273, United States

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Raleigh, North Carolina, 27607, United States

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Cincinnati, Ohio, 45236, United States

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Oklahoma City, Oklahoma, 73120, United States

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Tulsa, Oklahoma, 74136, United States

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Medford, Oregon, 97504, United States

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Portland, Oregon, 97202, United States

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Pottstown, Pennsylvania, 19464, United States

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Scottdale, Pennsylvania, 15683, United States

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Greenville, South Carolina, 29615, United States

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North Charleston, South Carolina, 29420, United States

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Boerne, Texas, 78006, United States

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Dallas, Texas, 75231, United States

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DeSoto, Texas, 75115, United States

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El Paso, Texas, 79924, United States

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Kingwood, Texas, 77339, United States

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McKinney, Texas, 75069, United States

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Pearland, Texas, 77584, United States

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San Antonio, Texas, 78258, United States

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Victoria, Texas, 77901, United States

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West Jordan, Utah, 84088, United States

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Burke, Virginia, 22015, United States

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Portsmouth, Virginia, 23703, United States

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Spokane, Washington, 99218, United States

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Morgantown, West Virginia, 26505, United States

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Milwaukee, Wisconsin, 53228, United States

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Baotou, 014010, China

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Changsha, 410015, China

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Chengdu, 610072, China

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Chizhou, 247099, China

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Chongqing, 401320, China

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Guangzhou, 510150, China

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Guangzhou, 510163, China

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Haikou, 570208, China

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Hangzhou, 310005, China

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Hefei, 230061, China

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Hohhot, 010017, China

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Huizhou, 516001, China

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Jinan, 250001, China

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Jinhua, China

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Lanzhou, 730000, China

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Linhai, 317000, China

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Nanchang, 330006, China

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Pingxiang, 337055, China

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Qingdao, 266011, China

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Shanghai, 200080, China

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Shanghai, 201199, China

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Shanghai, 310000, China

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Shenyang, 110004, China

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Shenzhen, 518020, China

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Shijiazhuang, 50051, China

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Taiyuan, 030001, China

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Taiyuan, 030032, China

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Wenzhou, 325027, China

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Wuhan, 430030, China

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Xuzhou, 221000, China

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Xuzhou, 221009, China

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Yangzhou, 225003, China

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Yinchuan, 750001, China

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Zhengzhou, 450003, China

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Zhuji, 311899, China

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Cheras, 56000, Malaysia

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Petaling Jaya, 47500, Malaysia

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Chihuahua City, 31200, Mexico

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Cuernavaca, 62290, Mexico

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Culiacán, 80100, Mexico

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Durango, 34000, Mexico

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Guadalajara, 44130, Mexico

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Guadalajara, 44200, Mexico

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Mazatlán, 82000, Mexico

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Monterrey, 64060, Mexico

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Monterrey, 64465, Mexico

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San Juan del Río, 76800, Mexico

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Tijuana, 22010, Mexico

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Veracruz, 91900, Mexico

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Zapopan, 45138, Mexico

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Bangkoknoi, 10700, Thailand

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Khon Kaen, 40002, Thailand

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Mueang, 50200, Thailand

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Ratchathewi, 10400, Thailand

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Can Tho, 900000, Vietnam

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Haiphong, 180000, Vietnam

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Hanoi, 100000, Vietnam

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Ho Chi Minh City, 700000, Vietnam

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MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a Randomized, Placebo-controlled, Double-blind, Multicenter, 12-Week, 3-Way, Partial-replicate Crossover Pharmacodynamic Study to Assess the Equivalence of BDA MDI HFO Compared with BDA MDI HFA in Participants with Asthma.

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 16, 2024
• Study Start: July 22, 2024
• Primary Completion: March 3, 2026
• Study Completion: March 3, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

ME (13); CN (35); MY (2); TH (4); VN (4); US (70)