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
NCT ID: NCT06502366
Last Updated: 2025-12-15
Study Results
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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RECRUITING
PHASE3
398 participants
INTERVENTIONAL
2024-07-22
2026-03-03
Brief Summary
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Detailed Description
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The study duration for each participant will be approximately 14 to 15 weeks and will consist of:
1. A screening and placebo run-in period of approximately 2 weeks prior to the first dose of study intervention
2. 3 treatment periods of 4 weeks each
3. A final safety follow-up visit via telephone contact approximately 5 days after the final dose of study intervention
Participants will attend in-clinic visits 2 weeks apart during the screening/run-in period (Visits 1 and 2) and then every 4 weeks during the treatment period (Visits 3, 4, and 5).
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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BDA MDI HFO
160/180 µg Budesonide/albuterol pressurized inhalation suspension, HFO
BDA MDI HFO 160/180 μg
Budesonide/albuterol pressurized inhalation suspension, HFO
BDA MDI HFA
160/180 µg Budesonide/albuterol pressurized inhalation suspension, HFA
BDA MDI HFA 160/180 μg
Budesonide/albuterol pressurized inhalation suspension, HFA
Placebo MDI HFA
Placebo pressurized inhalation suspension, HFA
Placebo MDI HFA
Placebo pressurized inhalation suspension, HFA
Interventions
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BDA MDI HFO 160/180 μg
Budesonide/albuterol pressurized inhalation suspension, HFO
BDA MDI HFA 160/180 μg
Budesonide/albuterol pressurized inhalation suspension, HFA
Placebo MDI HFA
Placebo pressurized inhalation suspension, HFA
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Mobile, Alabama, United States
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Sheffield, Alabama, United States
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Phoenix, Arizona, United States
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Little Rock, Arkansas, United States
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Encinitas, California, United States
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Fullerton, California, United States
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Gardena, California, United States
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Huntington Beach, California, United States
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La Mesa, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Sacramento, California, United States
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San Bernardino, California, United States
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San Diego, California, United States
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San Jose, California, United States
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Santa Ana, California, United States
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Stockton, California, United States
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Van Nuys, California, United States
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Westminster, California, United States
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Englewood, Colorado, United States
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Wheat Ridge, Colorado, United States
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Washington D.C., District of Columbia, United States
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Boynton Beach, Florida, United States
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Miami, Florida, United States
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Tallahassee, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Rincon, Georgia, United States
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Savannah, Georgia, United States
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Boise, Idaho, United States
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Meridian, Idaho, United States
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River Forest, Illinois, United States
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Evansville, Indiana, United States
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Valparaiso, Indiana, United States
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Sioux City, Iowa, United States
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Louisville, Kentucky, United States
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Lafayette, Louisiana, United States
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New Orleans, Louisiana, United States
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White Marsh, Maryland, United States
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Flint, Michigan, United States
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Columbia, Missouri, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Monticello, New York, United States
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New York, New York, United States
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Watertown, New York, United States
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Charlotte, North Carolina, United States
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Raleigh, North Carolina, United States
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Cincinnati, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Pottstown, Pennsylvania, United States
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Scottdale, Pennsylvania, United States
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Charleston, South Carolina, United States
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Greenville, South Carolina, United States
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North Charleston, South Carolina, United States
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Spartanburg, South Carolina, United States
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Boerne, Texas, United States
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Dallas, Texas, United States
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DeSoto, Texas, United States
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El Paso, Texas, United States
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Kingwood, Texas, United States
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McKinney, Texas, United States
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Pearland, Texas, United States
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San Antonio, Texas, United States
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Victoria, Texas, United States
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West Jordan, Utah, United States
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Burke, Virginia, United States
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Portsmouth, Virginia, United States
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Spokane, Washington, United States
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Morgantown, West Virginia, United States
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Milwaukee, Wisconsin, United States
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Baotou, , China
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Changsha, , China
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Chengdu, , China
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Chizhou, , China
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Chongqing, , China
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Guangzhou, , China
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Guangzhou, , China
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Haikou, , China
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Hangzhou, , China
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Hefei, , China
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Hohhot, , China
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Huizhou, , China
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Jinan, , China
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Jinhua, , China
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Lanzhou, , China
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Linhai, , China
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Nanchang, , China
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Pingxiang, , China
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Qingdao, , China
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Shanghai, , China
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Shanghai, , China
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Shanghai, , China
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Shenyang, , China
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Shenzhen, , China
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Shijiazhuang, , China
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Taiyuan, , China
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Taiyuan, , China
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Wenzhou, , China
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Wuhan, , China
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Xi'an, , China
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Xuzhou, , China
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Xuzhou, , China
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Yangzhou, , China
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Yinchuan, , China
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Zhengzhou, , China
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Zhuji, , China
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Alor Star, , Malaysia
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Ampang, , Malaysia
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Cheras, , Malaysia
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Petaling Jaya, , Malaysia
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Rawang, , Malaysia
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Sandakan, , Malaysia
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Chihuahua City, , Mexico
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Cuernavaca, , Mexico
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Culiacán, , Mexico
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Durango, , Mexico
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Guadalajara, , Mexico
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Guadalajara, , Mexico
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Mazatlán, , Mexico
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Mexico City, , Mexico
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Mérida, , Mexico
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Monterrey, , Mexico
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Monterrey, , Mexico
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San Juan del Río, , Mexico
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Tijuana, , Mexico
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Veracruz, , Mexico
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Zapopan, , Mexico
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Bangkoknoi, , Thailand
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Khon Kaen, , Thailand
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Mueang, , Thailand
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Ratchathewi, , Thailand
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Abu Dhabi, , United Arab Emirates
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Ashton-under-Lyne, , United Kingdom
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Glasgow, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Can Tho, , Vietnam
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Haiphong, , Vietnam
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Hanoi, , Vietnam
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Ho Chi Minh City, , Vietnam
Countries
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Central Contacts
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Other Identifiers
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D6933C00002
Identifier Type: -
Identifier Source: org_study_id
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