A Study to Investigate the Effect on Lung Function of BDA Formulated With a New Propellant (HFO) Compared With an Approved Asthma Treatment (BDA With HFA Propellant) in Participants With Asthma
NCT Number: NCT06502366
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Asthma
Interventions: DRUG: BDA MDI HFO 160/180 μg|DRUG: BDA MDI HFA 160/180 μg|DRUG: Placebo MDI HFA
Sponsor: AstraZeneca
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 398
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-22
Completion Date: 2026-02-24
Locations: Research Site, Mobile, Alabama, 36608, United States|Research Site, Sheffield, Alabama, 35660, United States|Research Site, Phoenix, Arizona, 85018, United States|Research Site, Little Rock, Arkansas, 72205, United States|Research Site, Banning, California, 92220, United States|Research Site, Encinitas, California, 92024, United States|Research Site, Fullerton, California, 92835, United States|Research Site, Gardena, California, 90247, United States|Research Site, Huntington Beach, California, 92647, United States|Research Site, La Mesa, California, 91942, United States|Research Site, Los Angeles, California, 90025, United States|Research Site, Los Angeles, California, 90048, United States|Research Site, Panorama City, California, 91402, United States|Research Site, Sacramento, California, 95821, United States|Research Site, San Diego, California, 92123, United States|Research Site, San Jose, California, 95117, United States|Research Site, Santa Ana, California, 92704, United States|Research Site, Stockton, California, 95207, United States|Research Site, Westminster, California, 92683, United States|Research Site, Englewood, Colorado, 80110, United States|Research Site, Wheat Ridge, Colorado, 80033, United States|Research Site, Washington, District of Columbia, 20016, United States|Research Site, Boynton Beach, Florida, 33435, United States|Research Site, Tallahassee, Florida, 32308, United States|Research Site, Atlanta, Georgia, 30328, United States|Research Site, Rincon, Georgia, 31326, United States|Research Site, Savannah, Georgia, 31406, United States|Research Site, Boise, Idaho, 83706, United States|Research Site, Meridian, Idaho, 83646, United States|Research Site, River Forest, Illinois, 60305, United States|Research Site, Evansville, Indiana, 47715, United States|Research Site, Valparaiso, Indiana, 46383, United States|Research Site, Sioux City, Iowa, 51106, United States|Research Site, Lexington, Kentucky, 40509, United States|Research Site, Louisville, Kentucky, 40217, United States|Research Site, Lafayette, Louisiana, 70508, United States|Research Site, Metairie, Louisiana, 70006, United States|Research Site, White Marsh, Maryland, 21162, United States|Research Site, Flint, Michigan, 48504, United States|Research Site, Columbia, Missouri, 65203, United States|Research Site, Saint Louis, Missouri, 63141, United States|Research Site, Omaha, Nebraska, 68134, United States|Research Site, Middletown, New York, 10940, United States|Research Site, New York, New York, 10036, United States|Research Site, Watertown, New York, 13601, United States|Research Site, Charlotte, North Carolina, 28273, United States|Research Site, Raleigh, North Carolina, 27607, United States|Research Site, Cincinnati, Ohio, 45236, United States|Research Site, Medford, Oregon, 97504, United States|Research Site, Portland, Oregon, 97202, United States|Research Site, DuBois, Pennsylvania, 15801, United States|Research Site, Pottstown, Pennsylvania, 19464, United States|Research Site, Scottdale, Pennsylvania, 15683, United States|Research Site, Charleston, South Carolina, 29414, United States|Research Site, Greenville, South Carolina, 29615, United States|Research Site, North Charleston, South Carolina, 29420, United States|Research Site, Spartanburg, South Carolina, 29303, United States|Research Site, Boerne, Texas, 78006, United States|Research Site, Dallas, Texas, 75231, United States|Research Site, Dallas, Texas, 75231, United States|Research Site, DeSoto, Texas, 75115, United States|Research Site, Kingwood, Texas, 77339, United States|Research Site, San Antonio, Texas, 78258, United States|Research Site, Victoria, Texas, 77901, United States|Research Site, West Jordan, Utah, 84088, United States|Research Site, Burke, Virginia, 22015, United States|Research Site, Portsmouth, Virginia, 23703, United States|Research Site, Spokane, Washington, 99218, United States|Research Site, Morgantown, West Virginia, 26505, United States|Research Site, Milwaukee, Wisconsin, 53228, United States|Research Site, Anhui, 230061, China|Research Site, Baotou, 014010, China|Research Site, Changsha, 410015, China|Research Site, Chengdu, 610072, China|Research Site, Guangzhou, 510150, China|Research Site, Guangzhou, 510163, China|Research Site, Haikou, 570208, China|Research Site, Hangzhou, 310005, China|Research Site, Hohhot, 010017, China|Research Site, Huizhou, 516001, China|Research Site, Jinan, 250001, China|Research Site, Jinhua, China|Research Site, Lanzhou, 730000, China|Research Site, Linhai, 318000, China|Research Site, Nanchang, 330006, China|Research Site, Pingxiang, 337055, China|Research Site, Qingdao, 266011, China|Research Site, Shanghai, 200080, China|Research Site, Shanghai, 201199, China|Research Site, Shanghai, 310000, China|Research Site, Shenyang, 110004, China|Research Site, Shijiazhuang, 50051, China|Research Site, Taiyuan, 030001, China|Research Site, Taiyuan, 030032, China|Research Site, Wenzhou, 325027, China|Research Site, Xi'an, 710006, China|Research Site, Xuzhou, 221000, China|Research Site, Xuzhou, 221009, China|Research Site, Yangzhou, 225003, China|Research Site, Yinchuan, 750001, China|Research Site, Zhejiang, 311800, China|Research Site, Zhengzhou, 450003, China|Research Site, Cheras, 56000, Malaysia|Research Site, Petaling Jaya, 47500, Malaysia|Research Site, Sandakan, 90000, Malaysia|Research Site, Chihuahua, 31200, Mexico|Research Site, Cuernavaca, 62290, Mexico|Research Site, Culiacan, 80100, Mexico|Research Site, Durango, 34000, Mexico|Research Site, Guadalajara, 44130, Mexico|Research Site, Guadalajara, 44200, Mexico|Research Site, Mazatlán, 82000, Mexico|Research Site, Mexico City, 3103, Mexico|Research Site, Monterrey, 64060, Mexico|Research Site, Monterrey, 64465, Mexico|Research Site, Mérida, 97070, Mexico|Research Site, San Juan del Rio, 76800, Mexico|Research Site, Tijuana, 22010, Mexico|Research Site, Veracruz, 91900, Mexico|Research Site, Zapopan, 45138, Mexico|Research Site, Bangkoknoi, 10700, Thailand|Research Site, Khon Kaen, 40002, Thailand|Research Site, Mueang, 50200, Thailand|Research Site, Ratchathewi, 10400, Thailand|Research Site, Abu Dhabi, United Arab Emirates|Research Site, Ashton-under-Lyne, OL6 6EW, United Kingdom|Research Site, Glasgow, G20 7BE, United Kingdom|Research Site, Newcastle, NE6 1SG, United Kingdom|Research Site, Hai Phong, 180000, Vietnam|Research Site, Hanoi, 100000, Vietnam|Research Site, Ho Chi Minh City, 700000, Vietnam|Research Site, Ho Chi Minh, 700000, Vietnam

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.

Primary Outcome Measures: 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 Outcome Measures: Change from baseline in morning pre-dose trough FEV1, 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 morning pre-dose trough FEV1, 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