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

Last updated: March 25, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

3

Condition

Asthma

Treatment

BDA MDI HFO 160/180 μg

Placebo MDI HFA

BDA MDI HFA 160/180 μg

Clinical Study ID

NCT06502366
D6933C00002
  • Ages > 18
  • All Genders

Study 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.

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

Total Participants: 398
Treatment Group(s): 3
Primary Treatment: BDA MDI HFO 160/180 μg
Phase: 3
Study Start date:
July 22, 2024
Estimated Completion Date:
March 03, 2026

Study Description

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.

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).

Connect with a study center

  • Research Site

    Anhui, 230061
    China

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    Baotou, 014010
    China

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  • Research Site

    Changsha, 410015
    China

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    Chengdu, 610072
    China

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    Chongqing, 401320
    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,
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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, 201199
    China

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    Shenyang, 110004
    China

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    Shenzhen, 518020
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    Shijiazhuang, 50051
    China

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    Taiyuan, 030001
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    Wenzhou, 325027
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    Wuhan, 430030
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    Xi'an, 710006
    China

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    Xuzhou, 221000
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    Yangzhou, 225003
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    Yinchuan, 750001
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    Zhejiang, 311800
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    Zhengzhou, 450003
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    Zhuji, 311899
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    Alor Setar, 05400
    Malaysia

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    Ampang, 68000
    Malaysia

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    Cheras, 56000
    Malaysia

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    Petaling Jaya, 47500
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    Rawang, 48050
    Malaysia

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    Sandakan, 90000
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    Chihuahua, 31200
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    Cuernavaca, 62290
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    Culiacan, 80100
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    Durango, 34000
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    Guadalajara, 44130
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    Mazatlán, 82000
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    Mexico City, 3103
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    Monterrey, 64060
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    Mérida, 97070
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    San Juan del Rio, 76800
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    Tijuana, 22010
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    Veracruz, 91900
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    Zapopan, 45138
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    Bangkoknoi, 10700
    Thailand

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    Khon Kaen, 40002
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    Mueang, 50200
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    Ratchathewi, 10400
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    Abu Dhabi,
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    Ashton-under-Lyne, OL6 6EW
    United Kingdom

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    Glasgow, G20 7BE
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    Newcastle, NE6 1SG
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    Newcastle-Upon-Tyne, NE6 1SG
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    Mobile, Alabama 36608
    United States

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    Sheffield, Alabama 35660
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    Phoenix, Arizona 85018
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    Little Rock, Arkansas 72205
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    Banning, California 92220
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    Encinitas, California 92024
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    Fullerton, California 92835
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    Gardena, California 90247
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    Huntington Beach, California 92647
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    La Mesa, California 91942
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    Los Angeles, California 90048
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    Panorama City, California 91402
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    Sacramento, California 95821
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    San Bernardino, California 92408
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    San Diego, California 92123
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    San Jose, California 95117
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    Santa Ana, California 92704
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    Stockton, California 95207
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    Westminster, California 92683
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    Washington, District of Columbia 20016
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    Tallahassee, Florida 32308
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    Atlanta, Georgia 30328
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    Rincon, Georgia 31326
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    River Forest, Illinois 60305
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    Evansville, Indiana 47715
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    Valparaiso, Indiana 46383
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    Sioux City, Iowa 51106
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    Lexington, Kentucky 40509
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    Louisville, Kentucky 40217
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    Lafayette, Louisiana 70508
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    Metairie, Louisiana 70006
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    New Orleans, Louisiana 70119
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    White Marsh, Maryland 21162
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    Flint, Michigan 48504
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    Columbia, Missouri 65203
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    Saint Louis, Missouri 63141
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    Bellevue, Nebraska 68123
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    Omaha, Nebraska 68134
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    Middletown, New York 10940
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    Monticello, New York 12701
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    New York, New York 10036
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    Watertown, New York 13601
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    Charlotte, North Carolina 28273
    United States

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    Raleigh, North Carolina 27607
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    Cincinnati, Ohio 45236
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    Medford, Oregon 97504
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    Portland, Oregon 97202
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    DuBois, Pennsylvania 15801
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    Pottstown, Pennsylvania 19464
    United States

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    Scottdale, Pennsylvania 15683
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    Charleston, South Carolina 29414
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    Greenville, South Carolina 29615
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    North Charleston, South Carolina 29420
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    Spartanburg, South Carolina 29303
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    Boerne, Texas 78006
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    Dallas, Texas 75231
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    DeSoto, Texas 75115
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    Kingwood, Texas 77339
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    San Antonio, Texas 78258
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    Victoria, Texas 77901
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    West Jordan, Utah 84088
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    Burke, Virginia 22015
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    Portsmouth, Virginia 23703
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    Spokane, Washington 99218
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    Morgantown, West Virginia 26505
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    Milwaukee, Wisconsin 53228
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    Hai Phong, 180000
    Vietnam

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    Hanoi, 100000
    Vietnam

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    Ho Chi Minh, 700000
    Vietnam

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  • Research Site

    Ho Chi Minh City, 700000
    Vietnam

    Site Not Available

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