AsthmaPhase 3NCT06502366
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
A Phase 3 study testing BDA MDI HFO 160/180 μg and BDA MDI HFA 160/180 μg in people with Asthma, run by AstraZeneca at 128 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- BDA MDI HFO 160/180 μg and BDA MDI HFA 160/180 μg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 424 participants
- Where
- 128 sitesin 6 countries
- Study dates
- 22 Jul 2024to 17 Apr 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
128 sites in 6 countries.
128 sites in 6 countries
United States70 sites
Research Site
Atlanta, Georgia, 30328
Research Site
Boerne, Texas, 78006
Research Site
Boynton Beach, Florida, 33435
Research Site
Burke, Virginia, 22015
Research Site
Charlotte, North Carolina, 28273
Research Site
Cincinnati, Ohio, 45236
Research Site
Columbia, Missouri, 65203
Research Site
Dallas, Texas, 75231
Research Site
DeSoto, Texas, 75115
Research Site
El Paso, Texas, 79924
Research Site
Encinitas, California, 92024
Research Site
Englewood, Colorado, 80110
Research Site
Evansville, Indiana, 47715
Research Site
Flint, Michigan, 48504
Research Site
Fullerton, California, 92835
Research Site
Gardena, California, 90247
Research Site
Greenville, South Carolina, 29615
Research Site
Huntington Beach, California, 92647
Research Site
Kingwood, Texas, 77339
Research Site
La Mesa, California, 91942
Research Site
Lafayette, Louisiana, 70508
Research Site
Little Rock, Arkansas, 72205
Research Site
Los Angeles, California, 90025
Research Site
Los Angeles, California, 90048
Research Site
Louisville, Kentucky, 40217
Research Site
McKinney, Texas, 75069
Research Site
Medford, Oregon, 97504
Research Site
Meridian, Idaho, 83646
Research Site
Miami, Florida, 33175
Research Site
Milwaukee, Wisconsin, 53228
Research Site
Mobile, Alabama, 36608
Research Site
Monticello, New York, 12701
Research Site
Morgantown, West Virginia, 26505
Research Site
New Orleans, Louisiana, 70119
Research Site
New York, New York, 10036
Research Site
North Charleston, South Carolina, 29420
Research Site
Oklahoma City, Oklahoma, 73120
Research Site
Omaha, Nebraska, 68134
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Pearland, Texas, 77584
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Phoenix, Arizona, 85018
Research Site
Portland, Oregon, 97202
Research Site
Portsmouth, Virginia, 23703
Research Site
Pottstown, Pennsylvania, 19464
Research Site
Raleigh, North Carolina, 27607
Research Site
Rincon, Georgia, 31326
Research Site
River Forest, Illinois, 60305
Research Site
Sacramento, California, 95821
Research Site
San Antonio, Texas, 78258
Research Site
San Bernardino, California, 92408
Research Site
San Diego, California, 92123
Research Site
San Jose, California, 95117
Research Site
Santa Ana, California, 92704
Research Site
Savannah, Georgia, 31406
Research Site
Scottdale, Pennsylvania, 15683
Research Site
Sheffield, Alabama, 35660
Research Site
Sioux City, Iowa, 51106
Research Site
Spokane, Washington, 99218
Research Site
St Louis, Missouri, 63141
Research Site
Stockton, California, 95207
Research Site
Tallahassee, Florida, 32308
Research Site
Tampa, Florida, 33607
Research Site
Tulsa, Oklahoma, 74136
Research Site
Valparaiso, Indiana, 46383
Research Site
Victoria, Texas, 77901
Research Site
Washington D.C., District of Columbia, 20016
Research Site
Watertown, New York, 13601
Research Site
West Jordan, Utah, 84088
Research Site
Westminster, California, 92683
Research Site
Wheat Ridge, Colorado, 80033
Research Site
White Marsh, Maryland, 21162
China35 sites
Research Site
Baotou, 014010
Research Site
Changsha, 410015
Research Site
Chengdu, 610072
Research Site
Chizhou, 247099
Research Site
Chongqing, 401320
Research Site
Guangzhou, 510150
Research Site
Guangzhou, 510163
Research Site
Haikou, 570208
Research Site
Hangzhou, 310005
Research Site
Hefei, 230061
Research Site
Hohhot, 010017
Research Site
Huizhou, 516001
Research Site
Jinan, 250001
Research Site
Jinhua
Research Site
Lanzhou, 730000
Research Site
Linhai, 317000
Research Site
Nanchang, 330006
Research Site
Pingxiang, 337055
Research Site
Qingdao, 266011
Research Site
Shanghai, 200080
Research Site
Shanghai, 201199
Research Site
Shanghai, 310000
Research Site
Shenyang, 110004
Research Site
Shenzhen, 518020
Research Site
Shijiazhuang, 50051
Research Site
Taiyuan, 030001
Research Site
Taiyuan, 030032
Research Site
Wenzhou, 325027
Research Site
Wuhan, 430030
Research Site
Xuzhou, 221000
Research Site
Xuzhou, 221009
Research Site
Yangzhou, 225003
Research Site
Yinchuan, 750001
Research Site
Zhengzhou, 450003
Research Site
Zhuji, 311899
Mexico13 sites
Research Site
Chihuahua City, 31200
Research Site
Cuernavaca, 62290
Research Site
Culiacán, 80100
Research Site
Durango, 34000
Research Site
Guadalajara, 44130
Research Site
Guadalajara, 44200
Research Site
Mazatlán, 82000
Research Site
Monterrey, 64060
Research Site
Monterrey, 64465
Research Site
San Juan del Río, 76800
Research Site
Tijuana, 22010
Research Site
Veracruz, 91900
Research Site
Zapopan, 45138
Thailand4 sites
Research Site
Bangkoknoi, 10700
Research Site
Khon Kaen, 40002
Research Site
Mueang, 50200
Research Site
Ratchathewi, 10400
Vietnam4 sites
Research Site
Can Tho, 900000
Research Site
Haiphong, 180000
Research Site
Hanoi, 100000
Research Site
Ho Chi Minh City, 700000
Malaysia2 sites
Research Site
Cheras, 56000
Research Site
Petaling Jaya, 47500
About this study
Official title: A Randomized, Placebo-controlled, Double-blind, Multicenter, 12-Week, 3-Way, Partial-replicate Crossover Pharmacodynamic Study to Assess the Equivalence of Budesonide and Albuterol (BDA) Delivered by MDI HFO Compared With BDA Delivered by MDI HFA in Participants With Asthma
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.
Read the detailed 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:
- A screening and placebo run-in period of approximately 2 weeks prior to the first dose of study intervention
- 3 treatment periods of 4 weeks each
- 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
- Asthma
- Being tested
- BDA MDI HFO 160/180 μg, BDA MDI HFA 160/180 μg, Placebo MDI HFA
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BDA MDI HFO 160/180 μgDrug
Budesonide/albuterol pressurized inhalation suspension, HFO
BDA MDI HFA 160/180 μgDrug
Budesonide/albuterol pressurized inhalation suspension, HFA
Placebo MDI HFADrug
Placebo pressurized inhalation suspension, HFA
| Study group | Role | What they receive |
|---|---|---|
| BDA MDI HFO | Active comparator | 160/180 µg Budesonide/albuterol pressurized inhalation suspension, HFO Receives: Drug: BDA MDI HFO 160/180 μg |
| BDA MDI HFA | Active comparator | 160/180 µg Budesonide/albuterol pressurized inhalation suspension, HFA Receives: Drug: BDA MDI HFA 160/180 μg |
| Placebo MDI HFA | Placebo comparator | Placebo pressurized inhalation suspension, HFA Receives: Drug: Placebo MDI HFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Change from baseline at Day 29
Secondary outcomes (2)
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.
Measured: 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
Measured: Change from baseline at Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start22 Jul 2024
- Primary completion17 Apr 2026
- Study completion17 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 424 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502366
- Sponsor's protocol ID
- D6933C00002
- Status last verified
- May 2026
- First submitted
- 9 Jul 2024
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blind, Multicenter, 12-Week, 3-Way, Partial-replicate Crossover Pharmacodynamic Study to Assess the Equivalence of Budesonide and Albuterol (BDA) Delivered by MDI HFO Compared With BDA Delivered by MDI HFA in Participants With Asthma
- ClinicalTrials.gov ID
- NCT06502366
- Acronym / sponsor ID
- D6933C00002
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 424 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 17 Apr 2026 (actual)
- Study completion
- 17 Apr 2026 (actual)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- A screening and placebo run-in period of approximately 2 weeks prior to the first dose of study intervention
- 3 treatment periods of 4 weeks each
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| BDA MDI HFO | Active comparator | Drug: BDA MDI HFO 160/180 μg160/180 µg Budesonide/albuterol pressurized inhalation suspension, HFO |
| BDA MDI HFA | Active comparator | Drug: BDA MDI HFA 160/180 μg160/180 µg Budesonide/albuterol pressurized inhalation suspension, HFA |
| Placebo MDI HFA | Placebo comparator | Drug: Placebo MDI HFAPlacebo pressurized inhalation suspension, HFA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BDA MDI HFO 160/180 μgBudesonide/albuterol pressurized inhalation suspension, HFO | Drug | BDA MDI HFO |
| BDA MDI HFA 160/180 μgBudesonide/albuterol pressurized inhalation suspension, HFA | Drug | BDA MDI HFA |
| Placebo MDI HFAPlacebo pressurized inhalation suspension, HFA | Drug | Placebo MDI HFA |
Primary outcome
Change from baseline in peak FEV1 in 0-60 minutes after dosing at Day 29
Time frame: Change from baseline 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 in peak FEV1 in 0-60 minutes after dosing at Day 29
Time frame: Change from baseline 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
2 secondary outcomes
Change from baseline in morning pre-dose trough FEV1
Time frame: Change from baseline at Day 29
Change from baseline in morning pre-dose trough FEV1
Time frame: Change from baseline at Day 29
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
128 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BDA MDI HFO 160/180 μg and BDA MDI HFA 160/180 μg in people with Asthma, run by AstraZeneca at 128 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 128 sites in United States, China, Mexico, Thailand, Vietnam and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in peak FEV1 in 0-60 minutes after dosing at Day 29 (time frame: Change from baseline at Day 29). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.