Phase
Condition
Asthma
Treatment
BDA MDI HFO 160/180 μg
Placebo MDI HFA
BDA MDI HFA 160/180 μg
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 12months 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 stableon therapy for a minimum of 3 months prior to Visit 1; participants using low-doseICSLABA maintenance regimens are required to be stable on therapy for a minimum of 6months prior to Visit 1.
Participants with a pre-bronchodilator FEV1 of ≥ 60% and < 90% predicted normal atVisit 1 or Visit 1a.
Participants with a pre-dose FEV1 of ≥ 60% and < 90% predicted normal at Visit 2that 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 studyprovided SABA at Visit 1 or Visit 1a.
Participants able to demonstrate acceptable spirometry performance as defined by theacceptability and repeatability criteria in the ATS/ERS Standardization ofSpirometry 2019 update
Participants who are willing and, in the opinion of the investigator, able to adjustcurrent 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
Exclusion Criteria:
Confirmed or suspected diagnosis of COPD or clinically significant non-asthmaairway/lung disease.
Systemic corticosteroid use (eg, prednisone for 3 or more days or a singledepo-injectable dose of corticosteroids) for any respiratory, immune, orallergy-attributed disease within 6 months prior to Visit 1.
An upper respiratory infection requiring antibiotic treatment that is not resolvedwithin 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 ventilationassociated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-relatedsyncopal 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 worseningasthma symptoms
Historical or current evidence of a clinically significant disease including, butnot 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), orgastrointestinal (eg, poorly controlled peptic ulcer, gastroesophageal refluxdisease) disorders. Significant is defined as any disease that, in the opinion ofthe investigator, would put the safety of the participant at risk through studyparticipation or that could affect the efficacy or safety analyses if thedisease/condition exacerbated during the study.
Unresectable cancer that has not been in complete remission for at least 5 yearsprior to Visit 1
Hospitalization for psychiatric disorder or attempted suicide within 1 year of Visit
- Known history of drug or alcohol abuse within 12 months of Visit 1 or known abuse atany time during the study.
Study Design
Study Description
Connect with a study center
Research Site
Anhui, 230061
ChinaSite Not Available
Research Site
Baotou, 014010
ChinaSite Not Available
Research Site
Changsha, 410015
ChinaActive - Recruiting
Research Site
Chengdu, 610072
ChinaActive - Recruiting
Research Site
Chongqing, 401320
ChinaActive - Recruiting
Research Site
Guangzhou, 510163
ChinaSite Not Available
Research Site
Haikou, 570208
ChinaActive - Recruiting
Research Site
Hangzhou, 310005
ChinaActive - Recruiting
Research Site
Hefei, 230061
ChinaActive - Recruiting
Research Site
Hohhot, 010017
ChinaSite Not Available
Research Site
Huizhou, 516001
ChinaActive - Recruiting
Research Site
Jinan, 250001
ChinaSite Not Available
Research Site
Jinhua,
ChinaActive - Recruiting
Research Site
Lanzhou, 730000
ChinaActive - Recruiting
Research Site
Linhai, 317000
ChinaActive - Recruiting
Research Site
Nanchang, 330006
ChinaActive - Recruiting
Research Site
Pingxiang, 337055
ChinaActive - Recruiting
Research Site
Qingdao, 266011
ChinaSite Not Available
Research Site
Shanghai, 201199
ChinaActive - Recruiting
Research Site
Shenyang, 110004
ChinaSite Not Available
Research Site
Shenzhen, 518020
ChinaSite Not Available
Research Site
Shijiazhuang, 50051
ChinaActive - Recruiting
Research Site
Taiyuan, 030001
ChinaActive - Recruiting
Research Site
Wenzhou, 325027
ChinaActive - Recruiting
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Wuhan, 430030
ChinaSite Not Available
Research Site
Xi'an, 710006
ChinaSite Not Available
Research Site
Xuzhou, 221000
ChinaActive - Recruiting
Research Site
Yangzhou, 225003
ChinaSite Not Available
Research Site
Yinchuan, 750001
ChinaActive - Recruiting
Research Site
Zhejiang, 311800
ChinaSite Not Available
Research Site
Zhengzhou, 450003
ChinaActive - Recruiting
Research Site
Zhuji, 311899
ChinaActive - Recruiting
Research Site
Alor Setar, 05400
MalaysiaSite Not Available
Research Site
Ampang, 68000
MalaysiaSite Not Available
Research Site
Cheras, 56000
MalaysiaSite Not Available
Research Site
Petaling Jaya, 47500
MalaysiaActive - Recruiting
Research Site
Rawang, 48050
MalaysiaSite Not Available
Research Site
Sandakan, 90000
MalaysiaSite Not Available
Research Site
Chihuahua, 31200
MexicoSite Not Available
Research Site
Cuernavaca, 62290
MexicoSite Not Available
Research Site
Culiacan, 80100
MexicoSite Not Available
Research Site
Durango, 34000
MexicoSite Not Available
Research Site
Guadalajara, 44130
MexicoSite Not Available
Research Site
Mazatlán, 82000
MexicoSite Not Available
Research Site
Mexico City, 3103
MexicoSite Not Available
Research Site
Monterrey, 64060
MexicoSite Not Available
Research Site
Mérida, 97070
MexicoSite Not Available
Research Site
San Juan del Rio, 76800
MexicoSite Not Available
Research Site
Tijuana, 22010
MexicoSite Not Available
Research Site
Veracruz, 91900
MexicoSite Not Available
Research Site
Zapopan, 45138
MexicoSite Not Available
Research Site
Bangkoknoi, 10700
ThailandActive - Recruiting
Research Site
Khon Kaen, 40002
ThailandActive - Recruiting
Research Site
Mueang, 50200
ThailandActive - Recruiting
Research Site
Ratchathewi, 10400
ThailandActive - Recruiting
Research Site
Abu Dhabi,
United Arab EmiratesSite Not Available
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Ashton-under-Lyne, OL6 6EW
United KingdomSite Not Available
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Glasgow, G20 7BE
United KingdomSite Not Available
Research Site
Newcastle, NE6 1SG
United KingdomSite Not Available
Research Site
Newcastle-Upon-Tyne, NE6 1SG
United KingdomSite Not Available
Research Site
Mobile, Alabama 36608
United StatesActive - Recruiting
Research Site
Sheffield, Alabama 35660
United StatesActive - Recruiting
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Phoenix, Arizona 85018
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Little Rock, Arkansas 72205
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Banning, California 92220
United StatesSite Not Available
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Encinitas, California 92024
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Fullerton, California 92835
United StatesActive - Recruiting
Research Site
Gardena, California 90247
United StatesActive - Recruiting
Research Site
Huntington Beach, California 92647
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Research Site
La Mesa, California 91942
United StatesActive - Recruiting
Research Site
Los Angeles, California 90048
United StatesActive - Recruiting
Research Site
Panorama City, California 91402
United StatesSite Not Available
Research Site
Sacramento, California 95821
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San Bernardino, California 92408
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San Diego, California 92123
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Research Site
San Jose, California 95117
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Santa Ana, California 92704
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Research Site
Stockton, California 95207
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Research Site
Van Nuys, California 91405
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Research Site
Westminster, California 92683
United StatesSuspended
Research Site
Englewood, Colorado 80110
United StatesActive - Recruiting
Research Site
Wheat Ridge, Colorado 80033
United StatesActive - Recruiting
Research Site
Washington, District of Columbia 20016
United StatesActive - Recruiting
Research Site
Boynton Beach, Florida 33435
United StatesActive - Recruiting
Research Site
Tallahassee, Florida 32308
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Research Site
Atlanta, Georgia 30328
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Rincon, Georgia 31326
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Savannah, Georgia 31406
United StatesActive - Recruiting
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Boise, Idaho 83706
United StatesSite Not Available
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Meridian, Idaho 83646
United StatesActive - Recruiting
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River Forest, Illinois 60305
United StatesActive - Recruiting
Research Site
Evansville, Indiana 47715
United StatesActive - Recruiting
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Valparaiso, Indiana 46383
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Research Site
Sioux City, Iowa 51106
United StatesActive - Recruiting
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Lexington, Kentucky 40509
United StatesSite Not Available
Research Site
Louisville, Kentucky 40217
United StatesActive - Recruiting
Research Site
Lafayette, Louisiana 70508
United StatesActive - Recruiting
Research Site
Metairie, Louisiana 70006
United StatesSite Not Available
Research Site
New Orleans, Louisiana 70119
United StatesActive - Recruiting
Research Site
White Marsh, Maryland 21162
United StatesActive - Recruiting
Research Site
Flint, Michigan 48504
United StatesActive - Recruiting
Research Site
Columbia, Missouri 65203
United StatesActive - Recruiting
Research Site
Saint Louis, Missouri 63141
United StatesActive - Recruiting
Research Site
Bellevue, Nebraska 68123
United StatesSite Not Available
Research Site
Omaha, Nebraska 68134
United StatesActive - Recruiting
Research Site
Middletown, New York 10940
United StatesSite Not Available
Research Site
Monticello, New York 12701
United StatesActive - Recruiting
Research Site
New York, New York 10036
United StatesActive - Recruiting
Research Site
Watertown, New York 13601
United StatesActive - Recruiting
Research Site
Charlotte, North Carolina 28273
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Research Site
Raleigh, North Carolina 27607
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Research Site
Cincinnati, Ohio 45236
United StatesActive - Recruiting
Research Site
Medford, Oregon 97504
United StatesActive - Recruiting
Research Site
Portland, Oregon 97202
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Research Site
DuBois, Pennsylvania 15801
United StatesSite Not Available
Research Site
Pottstown, Pennsylvania 19464
United StatesActive - Recruiting
Research Site
Scottdale, Pennsylvania 15683
United StatesActive - Recruiting
Research Site
Charleston, South Carolina 29414
United StatesSite Not Available
Research Site
Greenville, South Carolina 29615
United StatesActive - Recruiting
Research Site
North Charleston, South Carolina 29420
United StatesActive - Recruiting
Research Site
Spartanburg, South Carolina 29303
United StatesSite Not Available
Research Site
Boerne, Texas 78006
United StatesActive - Recruiting
Research Site
Dallas, Texas 75231
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Research Site
DeSoto, Texas 75115
United StatesActive - Recruiting
Research Site
Kingwood, Texas 77339
United StatesActive - Recruiting
Research Site
San Antonio, Texas 78258
United StatesActive - Recruiting
Research Site
Victoria, Texas 77901
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Research Site
West Jordan, Utah 84088
United StatesActive - Recruiting
Research Site
Burke, Virginia 22015
United StatesActive - Recruiting
Research Site
Portsmouth, Virginia 23703
United StatesActive - Recruiting
Research Site
Spokane, Washington 99218
United StatesActive - Recruiting
Research Site
Morgantown, West Virginia 26505
United StatesActive - Recruiting
Research Site
Milwaukee, Wisconsin 53228
United StatesActive - Recruiting
Research Site
Hai Phong, 180000
VietnamActive - Recruiting
Research Site
Hanoi, 100000
VietnamActive - Recruiting
Research Site
Ho Chi Minh, 700000
VietnamActive - Recruiting
Research Site
Ho Chi Minh City, 700000
VietnamSite Not Available
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