A Phase 3 interventional study of BDA MDI and AS MDI in Asthma, sponsored by Bond Avillion 2 Development LP. Completed at 61 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2025-08-03.
Sponsored by Bond Avillion 2 Development LP · Phase 3, Interventional, and Treatment
This is a US study comparing the efficacy and safety of BDA MDI [Budesonide/Albuterol Sulfate (BDA) metered dose inhaler (MDI)] with AS [Albuterol Sulfate] MDI, both are administered as needed for up to 12 months.
This is a phase IIIb, multicenter, randomized, double-blind, parallel-group, event-driven, variable-length, decentralized study.
Participants from around 40 to 50 centers located in the US will be screened and randomized 1:1 to receive one of the following two treatments to be used as needed: BDA MDI (160/180 μg) and AS MDI (180 μg). Participants 12 years of age and older with asthma will be recruited with all visits conducted virtually.
Eligible participants must be using as-needed SABA (Short -acting β2agonist) alone, or as-needed SABA on a background of either low-dose ICS (Inhaled corticosteroid) or a LTRA (Leukotriene receptor agonist), for the treatment of asthma.
Participants will be stratified by pre-study asthma medication (SABA only, low-dose ICS + SABA and LTRA + SABA) and number of prior severe exacerbations (0, ≥1) in the 12 months prior to the Screening visit.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 2,516 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Bond Avillion 2 Development LP is the lead sponsor of 6 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive Budesonide and Albuterol Sulfate Pressurised Inhalation Suspension 160/180 μg up to a maximum of 12 inhalations to max dose.
Drug: BDA MDI
Participants will receive Albuterol Sulfate Pressurised Inhalation Suspension 180 μg up to a maximum of 12 inhalations to max dose.
Drug: AS MDI
Participants will receive Budesonide and Albuterol Sulfate MDI 80/90 μg per Actuation 1 to 6 doses (2 inhalations/dose) per day as needed via Oral inhalation route.
Participants will receive Albuterol Sulfate MDI 90 μg per Actuation 1 to 6 doses (2 inhalations/dose) per day as needed via Oral inhalation route.
Time to First Severe Asthma Exacerbation, While on Treatment Strategy, Interim Analysis Data Cut-off (Participants Aged >=12 Years)
The time to first severe asthma exacerbation was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the length in days from treatment initiation until the date of the first severe asthma exacerbation event. Participants were censored at treatment discontinuation, a step-up in maintenance therapy, or interim analysis DCO. An asthma exacerbation was considered severe if it resulted in at least one of the following: use of systemic steroids for at least 3 days, inpatient hospitalization due to asthma or emergency room visit that required systemic steroids, or death due to asthma. The primary outcome measure was analyzed at the interim analysis (22 April 2024). Since the primary objective was met at the interim analysis, it was not re-tested at final database lock. Since fewer than 50% of participants had an exacerbation event, the median survival time could not be calculated and instead the number of participants with an event is reported.
Time frame: From treatment initiation until the earliest occurrence of study completion, treatment discontinuation, step-up in maintenance therapy, or interim analysis DCO, up to one year following treatment initiation.
Time to First Severe Asthma Exacerbation, Treatment Policy Strategy, Interim Analysis Data Cut-off (Participants Aged >=12 Years)
The time to first severe asthma exacerbation was analyzed under the Treatment Policy strategy in the Full analysis set (FAS) and was defined as the length in days from treatment initiation until the date of first severe asthma exacerbation occurred. Participants were censored at study completion or withdrawal, or the interim analysis DCO. An asthma exacerbation was considered severe if it resulted in at least one of the following: use of systemic steroids for at least 3 days, inpatient hospitalization due to asthma or emergency room visit that required systemic steroids, or death due to asthma. The key secondary outcome measure was analyzed at the interim analysis (22 April 2024). Since the key secondary objective was met at the interim analysis, it was not re-tested at final database lock. Since fewer than 50% of participants had an exacerbation event, the median survival time could not be calculated and instead the number of participants with an event is reported.
Time frame: From treatment initiation until the earliest occurrence of study completion or withdrawal only, regardless of treatment discontinuation, a step-up in maintenance therapy or interim analysis DCO, up to one year following treatment initiation.
Time to First Severe Asthma Exacerbation, While on Treatment Strategy (Participants Aged >=18 Years)
The time to first severe asthma exacerbation was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the length in days from treatment initiation until the date of first severe asthma exacerbation event, including all events that occurred up to the final DCO (20 September 2024). Participants were censored at treatment discontinuation or a step-up in maintenance therapy. An asthma exacerbation was considered severe if it results in at least one of the following: use of systemic steroids for at least 3 days, inpatient hospitalization due to asthma or emergency room visit that required systemic steroids, or death due to asthma. Since fewer than 50% of participants had an exacerbation event, the median survival time could not be calculated and instead the number of participants with an event is reported.
Time frame: From treatment initiation until the earliest occurrence of study completion, treatment discontinuation or a step-up in maintenance therapy, up to one year following treatment initiation.
Time to First Severe Asthma Exacerbation, Treatment Policy Strategy (Participants Aged >=18 Years)
The time to first severe asthma exacerbation was analyzed under the Treatment Policy strategy in the Full analysis set (FAS) and was defined as the length in days from treatment initiation until the date of first severe asthma exacerbation event, including all events that occurred up to the Final DCO (20 September 2024). Participants were censored at study completion or withdrawal. An asthma exacerbation was considered severe if it resulted in at least one of the following: use of systemic steroids for at least 3 days, inpatient hospitalization due to asthma or emergency room visit that required systemic steroids, or death due to asthma. Since fewer than 50% of participants had an exacerbation event, the median survival time could not be calculated and instead the number of participants with an event is reported.
Time frame: From treatment initiation until the earliest occurrence of study completion or withdrawal only, regardless of treatment discontinuation or a step-up in maintenance therapy, up to one year following treatment initiation.
Annualized Severe Asthma Exacerbation Rate, While on Treatment Strategy (Participants Aged >=12 Years)
The annualized exacerbation rate was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the length in days from treatment initiation until the date of first severe asthma exacerbation event, including all events that occurred up to the final DCO (20 September 2024). Time at risk was defined as the cumulative number of days in the randomized treatment period across all participants in the treatment group, excluding the days during a severe exacerbation event and the 7 days following it resolving. An asthma exacerbation was considered severe if it resulted in at least one of the following: use of systemic steroids for at least 3 days, inpatient hospitalization due to asthma or emergency room visit that required systemic steroids, or death due to asthma.
Time frame: From treatment initiation until the earliest occurrence of study completion, treatment discontinuation or a step-up in maintenance therapy, up to one year following treatment initiation.
Annualized Severe Asthma Exacerbation Rate, While on Treatment Strategy (Participants Aged >=18 Years)
The annualized exacerbation rate was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the length in days from treatment initiation until the date of first severe asthma exacerbation event, including all events that occurred up to the final DCO (20 September 2024). Time at risk was defined as the cumulative number of days in the randomized treatment period across all participants in the treatment group, excluding the days during a severe exacerbation event and the 7 days following it resolving. An asthma exacerbation was considered severe if it resulted in at least one of the following: use of systemic steroids for at least 3 days, inpatient hospitalization due to asthma or emergency room visit that required systemic steroids, or death due to asthma.
Time frame: From treatment initiation until the earliest occurrence of study completion, treatment discontinuation or a step-up in maintenance therapy, up to one year following treatment initiation.
Total Systemic Glucocorticoid Exposure, While on Treatment Strategy (Participants Aged >=12 Years)
The total systemic glucocorticoid exposure was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the cumulative dose of SCS following a severe exacerbation from treatment initiation until study completion, treatment discontinuation or a step-up in maintenance therapy. SCS were normalized to prednisone equivalents when calculating total dose, patients whose total dose could not be normalized are excluded from analysis.
Time frame: From treatment initiation until the earliest occurrence of study completion, treatment discontinuation or a step-up in maintenance therapy, up to one year following treatment initiation.
Total Systemic Glucocorticoid Exposure, While on Treatment Strategy (Participants Aged >=18 Years)
The total systemic glucocorticoid exposure was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the cumulative dose of SCS following a severe exacerbation from treatment initiation until study completion, treatment discontinuation or a step-up in maintenance therapy. SCS were normalized to prednisone equivalents when calculating total dose, patients whose total dose could not be normalized are excluded from analysis.
Time frame: From treatment initiation until the earliest occurrence of study completion, treatment discontinuation or a step-up in maintenance therapy, up to one year following treatment initiation.
Total Duration of Systemic Glucocorticoid Exposure, While on Treatment Strategy (Participants Aged >=12 Years)
The total duration of systemic glucocorticoid exposure was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the cumulative days of SCS use following a severe exacerbation from treatment initiation until study completion, treatment discontinuation or a step-up in maintenance therapy. SCS were normalized to prednisone equivalents when calculating total dose, patients whose total dose could not be normalized are excluded from analysis.
Time frame: From treatment initiation until the earliest occurrence of study completion, treatment discontinuation or a step-up in maintenance therapy, up to one year following treatment initiation.
Total Duration of Systemic Glucocorticoid Exposure, While on Treatment Strategy (Participants Aged >=18 Years)
The total duration of systemic glucocorticoid exposure was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the cumulative days of SCS use following a severe exacerbation from treatment initiation until study completion, treatment discontinuation or a step-up in maintenance therapy. SCS were normalized to prednisone equivalents when calculating total dose, patients whose total dose could not be normalized are excluded from analysis.
Time frame: From treatment initiation until the earliest occurrence of study completion, treatment discontinuation or a step-up in maintenance therapy, up to one year following treatment initiation.
The first participant was screened on 2 September 2022. Participants were enrolled at 54 sites in the United States. Primary and first secondary objectives were tested at the interim analysis, on data collected up to 22 April 2024. Following the decision to stop the study early for overwhelming efficacy, participants were instructed to attend their end of study visits. The last participant last visit occurred on 22 August 2024 and final database lock was achieved on 20 September 2024.
| Milestone | BDA MDI (PT027) 160/180 μg | AS MDI (PT007) 180 µg |
|---|---|---|
| Started | 1257 | 1259 |
| Full analysis set; >=12 years | 1209 | 1212 |
| Full analysis set; >=18 years | 1180 | 1173 |
| Completed | 903 | 894 |
| Not completed | 354 | 365 |
| Withdrew: Withdrawal by subject | 51 | 64 |
| Withdrew: Adverse event | 6 | 20 |
| Withdrew: Protocol violation | 8 | 15 |
| Withdrew: Lack of therapeutic response | 0 | 1 |
| Withdrew: Lost to follow-up | 247 | 237 |
| Withdrew: Physician decision | 22 | 13 |
| Withdrew: Death | 2 | 1 |
| Withdrew: Withdrawal by parent/guardian | 0 | 1 |
| Withdrew: Pregnancy | 1 | 0 |
| Withdrew: Other | 17 | 13 |
The time to first severe asthma exacerbation was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the length in days from treatment initiation until the date of the first severe asthma exacerbation event. Participants were censored at treatment discontinuation, a step-up in maintenance therapy, or interim analysis DCO. An asthma exacerbation was considered severe if it resulted in at least one of the following: use of systemic steroids for at least 3 days, inpatient hospitalization due to asthma or emergency room visit that required systemic steroids, or death due to asthma. The primary outcome measure was analyzed at the interim analysis (22 April 2024). Since the primary objective was met at the interim analysis, it was not re-tested at final database lock. Since fewer than 50% of participants had an exacerbation event, the median survival time could not be calculated and instead the number of participants with an event is reported.
| Participants | BDA MDI (PT027) 160/180 μg | AS MDI (PT007) 180 µg |
|---|---|---|
| Time to First Severe Asthma Exacerbation, While on Treatment Strategy, Interim Analysis Data Cut-off (Participants Aged >=12 Years) | 62 | 110 |
The time to first severe asthma exacerbation was analyzed under the Treatment Policy strategy in the Full analysis set (FAS) and was defined as the length in days from treatment initiation until the date of first severe asthma exacerbation occurred. Participants were censored at study completion or withdrawal, or the interim analysis DCO. An asthma exacerbation was considered severe if it resulted in at least one of the following: use of systemic steroids for at least 3 days, inpatient hospitalization due to asthma or emergency room visit that required systemic steroids, or death due to asthma. The key secondary outcome measure was analyzed at the interim analysis (22 April 2024). Since the key secondary objective was met at the interim analysis, it was not re-tested at final database lock. Since fewer than 50% of participants had an exacerbation event, the median survival time could not be calculated and instead the number of participants with an event is reported.
| Participants | BDA MDI (PT027) 160/180 μg | AS MDI (PT007) 180 µg |
|---|---|---|
| Time to First Severe Asthma Exacerbation, Treatment Policy Strategy, Interim Analysis Data Cut-off (Participants Aged >=12 Years) | 64 | 114 |
The time to first severe asthma exacerbation was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the length in days from treatment initiation until the date of first severe asthma exacerbation event, including all events that occurred up to the final DCO (20 September 2024). Participants were censored at treatment discontinuation or a step-up in maintenance therapy. An asthma exacerbation was considered severe if it results in at least one of the following: use of systemic steroids for at least 3 days, inpatient hospitalization due to asthma or emergency room visit that required systemic steroids, or death due to asthma. Since fewer than 50% of participants had an exacerbation event, the median survival time could not be calculated and instead the number of participants with an event is reported.
| Participants | BDA MDI (PT027) 160/180 μg | AS MDI (PT007) 180 µg |
|---|---|---|
| Time to First Severe Asthma Exacerbation, While on Treatment Strategy (Participants Aged >=18 Years) | 71 | 126 |
The time to first severe asthma exacerbation was analyzed under the Treatment Policy strategy in the Full analysis set (FAS) and was defined as the length in days from treatment initiation until the date of first severe asthma exacerbation event, including all events that occurred up to the Final DCO (20 September 2024). Participants were censored at study completion or withdrawal. An asthma exacerbation was considered severe if it resulted in at least one of the following: use of systemic steroids for at least 3 days, inpatient hospitalization due to asthma or emergency room visit that required systemic steroids, or death due to asthma. Since fewer than 50% of participants had an exacerbation event, the median survival time could not be calculated and instead the number of participants with an event is reported.
| Participants | BDA MDI (PT027) 160/180 μg | AS MDI (PT007) 180 µg |
|---|---|---|
| Time to First Severe Asthma Exacerbation, Treatment Policy Strategy (Participants Aged >=18 Years) | 73 | 131 |
The annualized exacerbation rate was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the length in days from treatment initiation until the date of first severe asthma exacerbation event, including all events that occurred up to the final DCO (20 September 2024). Time at risk was defined as the cumulative number of days in the randomized treatment period across all participants in the treatment group, excluding the days during a severe exacerbation event and the 7 days following it resolving. An asthma exacerbation was considered severe if it resulted in at least one of the following: use of systemic steroids for at least 3 days, inpatient hospitalization due to asthma or emergency room visit that required systemic steroids, or death due to asthma.
| events per year | BDA MDI (PT027) 160/180 μg | AS MDI (PT007) 180 µg |
|---|---|---|
| Annualized Severe Asthma Exacerbation Rate, While on Treatment Strategy (Participants Aged >=12 Years) | 0.15 (0.11 to 0.20) | 0.32 (0.25 to 0.41) |
The annualized exacerbation rate was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the length in days from treatment initiation until the date of first severe asthma exacerbation event, including all events that occurred up to the final DCO (20 September 2024). Time at risk was defined as the cumulative number of days in the randomized treatment period across all participants in the treatment group, excluding the days during a severe exacerbation event and the 7 days following it resolving. An asthma exacerbation was considered severe if it resulted in at least one of the following: use of systemic steroids for at least 3 days, inpatient hospitalization due to asthma or emergency room visit that required systemic steroids, or death due to asthma.
| events per year | BDA MDI (PT027) 160/180 μg | AS MDI (PT007) 180 µg |
|---|---|---|
| Annualized Severe Asthma Exacerbation Rate, While on Treatment Strategy (Participants Aged >=18 Years) | 0.15 (0.12 to 0.20) | 0.33 (0.26 to 0.43) |
The total systemic glucocorticoid exposure was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the cumulative dose of SCS following a severe exacerbation from treatment initiation until study completion, treatment discontinuation or a step-up in maintenance therapy. SCS were normalized to prednisone equivalents when calculating total dose, patients whose total dose could not be normalized are excluded from analysis.
| mg/year | BDA MDI (PT027) 160/180 μg | AS MDI (PT007) 180 µg |
|---|---|---|
| Total Systemic Glucocorticoid Exposure, While on Treatment Strategy (Participants Aged >=12 Years) | 23.2 (0.0 to 2840.8) | 61.9 (0.0 to 21915.0) |
The total systemic glucocorticoid exposure was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the cumulative dose of SCS following a severe exacerbation from treatment initiation until study completion, treatment discontinuation or a step-up in maintenance therapy. SCS were normalized to prednisone equivalents when calculating total dose, patients whose total dose could not be normalized are excluded from analysis.
| mg/year | BDA MDI (PT027) 160/180 μg | AS MDI (PT007) 180 µg |
|---|---|---|
| Total Systemic Glucocorticoid Exposure, While on Treatment Strategy (Participants Aged >=18 Years) | 23.0 (0.0 to 2840.8) | 63.0 (0.0 to 21915.0) |
The total duration of systemic glucocorticoid exposure was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the cumulative days of SCS use following a severe exacerbation from treatment initiation until study completion, treatment discontinuation or a step-up in maintenance therapy. SCS were normalized to prednisone equivalents when calculating total dose, patients whose total dose could not be normalized are excluded from analysis.
| days | BDA MDI (PT027) 160/180 μg | AS MDI (PT007) 180 µg |
|---|---|---|
| Total Duration of Systemic Glucocorticoid Exposure, While on Treatment Strategy (Participants Aged >=12 Years) | 0.4 ± 2.17 | 0.9 ± 3.66 |
The total duration of systemic glucocorticoid exposure was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the cumulative days of SCS use following a severe exacerbation from treatment initiation until study completion, treatment discontinuation or a step-up in maintenance therapy. SCS were normalized to prednisone equivalents when calculating total dose, patients whose total dose could not be normalized are excluded from analysis.
| days | BDA MDI (PT027) 160/180 μg | AS MDI (PT007) 180 µg |
|---|---|---|
| Total Duration of Systemic Glucocorticoid Exposure, While on Treatment Strategy (Participants Aged >=18 Years) | 0.4 ± 2.20 | 0.9 ± 3.72 |
Collected over All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BDA MDI (PT027) 160/180 μg | 2/1,257 (0.2%) | 37/1,209 (3.1%) | 227/1,209 (18.8%) |
| AS MDI (PT007) 180 µg | 1/1,259 (0.1%) | 37/1,212 (3.1%) | 232/1,212 (19.1%) |
| Event | BDA MDI (PT027) 160/180 μg | AS MDI (PT007) 180 µg |
|---|---|---|
| AsthmaRespiratory, thoracic and mediastinal disorders | 3/1209 | 7/1212 |
| PneumoniaInfections and infestations | 0/1209 | 3/1212 |
| AppendicitisInfections and infestations | 2/1209 | 1/1212 |
| InfluenzaInfections and infestations | 2/1209 | 1/1212 |
| SyncopeNervous system disorders | 2/1209 | 0/1212 |
| Pancreatitis acuteGastrointestinal disorders | 0/1209 | 2/1212 |
| CholelithiasisHepatobiliary disorders | 0/1209 | 2/1212 |
| Back painMusculoskeletal and connective tissue disorders | 0/1209 | 2/1212 |
| COVID-19Infections and infestations | 1/1209 | 0/1212 |
| COVID-19 pneumoniaInfections and infestations | 1/1209 | 0/1212 |
| Event | BDA MDI (PT027) 160/180 μg | AS MDI (PT007) 180 µg |
|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 65/1209 | 73/1212 |
| COVID-19Infections and infestations | 62/1209 | 67/1212 |
| NasopharyngitisInfections and infestations | 45/1209 | 32/1212 |
| SinusitisInfections and infestations | 38/1209 | 30/1212 |
| BronchitisInfections and infestations | 29/1209 | 32/1212 |
| CoughRespiratory, thoracic and mediastinal disorders | 30/1209 | 29/1212 |
| Age, Categorical(Participants) | BDA MDI (PT027) 160/180 μg | AS MDI (PT007) 180 µg | Total |
|---|---|---|---|
| <=18 years | 29 | 39 | 68 |
| Between 18 and 65 years | 1100 | 1073 | 2173 |
| >=65 years | 80 | 100 | 180 |
| Age, Continuous(years) | BDA MDI (PT027) 160/180 μg | AS MDI (PT007) 180 µg | Total |
|---|---|---|---|
| Mean | 42.5 ± 14.33 | 42.9 ± 14.68 | 42.7 ± 14.51 |
| Sex: Female, Male(Participants) | BDA MDI (PT027) 160/180 μg | AS MDI (PT007) 180 µg | Total |
|---|---|---|---|
| Female | 810 | 843 | 1653 |
| Male | 399 | 369 | 768 |
| Ethnicity (NIH/OMB)(Participants) | BDA MDI (PT027) 160/180 μg | AS MDI (PT007) 180 µg | Total |
|---|---|---|---|
| Hispanic or Latino | 156 | 136 | 292 |
| Not Hispanic or Latino | 1052 | 1075 | 2127 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Race/Ethnicity, Customized(Participants) | BDA MDI (PT027) 160/180 μg | AS MDI (PT007) 180 µg | Total |
|---|---|---|---|
| White | 848 | 849 | 1697 |
| Black or African American | 219 | 219 | 438 |
| Asian | 28 | 28 | 56 |
| Native Hawaiian or other Pacific Islander | 2 | 2 | 4 |
| American Indian or Alaska Native | 9 | 5 | 14 |
| Multiple | 19 | 24 | 43 |
| Other | 47 | 52 | 99 |
| Not Reported | 37 | 32 | 69 |
| Missing | 0 | 1 | 1 |
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Bond Avillion 2 Development LP