Trial · NCT05505734
A Comparison of PT027 vs PT007 Used as Needed in Participants With Asthma
NCT05505734, Phase 3, Completed, Bond Avillion 2 Development LP; results first posted 2025-08-03
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ConductScience Library. A Comparison of PT027 vs PT007 Used as Needed in Participants With Asthma. Trials, record NCT05505734. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05505734
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Comparison of PT027 vs PT007 Used as Needed in Participants With Asthma
- NCT number
- NCT05505734
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,516 participants, actual
- Lead sponsor
- Bond Avillion 2 Development LP
- Conditions
- Asthma
- Interventions
- BDA MDI, AS MDI
- First posted
- 2022-08-18
- Last updated
- 2025-08-03
- Results first posted
- 2025-08-03
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to First Severe Asthma Exacerbation, While on Treatment Strategy, Interim Analysis Data Cut-off (Participants Aged >=12 Years) | 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. | 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. |
| Secondary | Time to First Severe Asthma Exacerbation, Treatment Policy Strategy, Interim Analysis Data Cut-off (Participants Aged >=12 Years) | 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. | 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. |
| Secondary | Time to First Severe Asthma Exacerbation, While on Treatment Strategy (Participants Aged >=18 Years) | 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 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. |
| Secondary | Time to First Severe Asthma Exacerbation, Treatment Policy Strategy (Participants Aged >=18 Years) | 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. | 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. |
| Secondary | Annualized Severe Asthma Exacerbation Rate, While on Treatment Strategy (Participants Aged >=12 Years) | 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 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. |
| Secondary | Annualized Severe Asthma Exacerbation Rate, While on Treatment Strategy (Participants Aged >=18 Years) | 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 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. |
| Secondary | Total Systemic Glucocorticoid Exposure, While on Treatment Strategy (Participants Aged >=12 Years) | 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 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. |
| Secondary | Total Systemic Glucocorticoid Exposure, While on Treatment Strategy (Participants Aged >=18 Years) | 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 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. |
| Secondary | Total Duration of Systemic Glucocorticoid Exposure, While on Treatment Strategy (Participants Aged >=12 Years) | 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 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. |
| Secondary | Total Duration of Systemic Glucocorticoid Exposure, While on Treatment Strategy (Participants Aged >=18 Years) | 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 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to First Severe Asthma Exacerbation, While on Treatment Strategy, Interim Analysis Data Cut-off (Participants Aged >=12 Years) | 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. | Full analysis set; \>=12 years | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to First Severe Asthma Exacerbation, Treatment Policy Strategy, Interim Analysis Data Cut-off (Participants Aged >=12 Years) | 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. | Full analysis set; \>=12 years | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to First Severe Asthma Exacerbation, While on Treatment Strategy (Participants Aged >=18 Years) | 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. | Full analysis set; \>=18 years | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to First Severe Asthma Exacerbation, Treatment Policy Strategy (Participants Aged >=18 Years) | 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. | Full analysis set; \>=18 years | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Annualized Severe Asthma Exacerbation Rate, While on Treatment Strategy (Participants Aged >=12 Years) | 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. | Full analysis set; \>=12 years | events per year | NUMBER |
| SECONDARY | Annualized Severe Asthma Exacerbation Rate, While on Treatment Strategy (Participants Aged >=18 Years) | 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. | Full analysis set; \>=18 years | events per year | NUMBER |
| SECONDARY | Total Systemic Glucocorticoid Exposure, While on Treatment Strategy (Participants Aged >=12 Years) | 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. | Full analysis set; \>=12 years | mg/year | MEAN |
| SECONDARY | Total Systemic Glucocorticoid Exposure, While on Treatment Strategy (Participants Aged >=18 Years) | 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. | Full analysis set; \>=18 years | mg/year | MEAN |
| SECONDARY | Total Duration of Systemic Glucocorticoid Exposure, While on Treatment Strategy (Participants Aged >=12 Years) | 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. | Full analysis set; \>=12 years | days | MEAN |
| SECONDARY | Total Duration of Systemic Glucocorticoid Exposure, While on Treatment Strategy (Participants Aged >=18 Years) | 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. | Full analysis set; \>=18 years | days | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to First Severe Asthma Exacerbation, While on Treatment Strategy, Interim Analysis Data Cut-off (Participants Aged >=12 Years) | BDA MDI (PT027) 160/180 μg | 62 | Participants | ||
| Time to First Severe Asthma Exacerbation, While on Treatment Strategy, Interim Analysis Data Cut-off (Participants Aged >=12 Years) | AS MDI (PT007) 180 µg | 110 | Participants | ||
| Time to First Severe Asthma Exacerbation, Treatment Policy Strategy, Interim Analysis Data Cut-off (Participants Aged >=12 Years) | BDA MDI (PT027) 160/180 μg | 64 | Participants | ||
| Time to First Severe Asthma Exacerbation, Treatment Policy Strategy, Interim Analysis Data Cut-off (Participants Aged >=12 Years) | AS MDI (PT007) 180 µg | 114 | Participants | ||
| Time to First Severe Asthma Exacerbation, While on Treatment Strategy (Participants Aged >=18 Years) | BDA MDI (PT027) 160/180 μg | 71 | Participants | ||
| Time to First Severe Asthma Exacerbation, While on Treatment Strategy (Participants Aged >=18 Years) | AS MDI (PT007) 180 µg | 126 | Participants | ||
| Time to First Severe Asthma Exacerbation, Treatment Policy Strategy (Participants Aged >=18 Years) | BDA MDI (PT027) 160/180 μg | 73 | Participants | ||
| Time to First Severe Asthma Exacerbation, Treatment Policy Strategy (Participants Aged >=18 Years) | AS MDI (PT007) 180 µg | 131 | Participants | ||
| Annualized Severe Asthma Exacerbation Rate, While on Treatment Strategy (Participants Aged >=12 Years) | BDA MDI (PT027) 160/180 μg | 0.15 | 95% Confidence Interval 0.11 to 0.20 | events per year | |
| Annualized Severe Asthma Exacerbation Rate, While on Treatment Strategy (Participants Aged >=12 Years) | AS MDI (PT007) 180 µg | 0.32 | 95% Confidence Interval 0.25 to 0.41 | events per year |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BDA MDI (PT027) 160/180 μg | 1,257 | |
| Overall Study | STARTED | AS MDI (PT007) 180 µg | 1,259 | |
| Overall Study | Full Analysis Set; >=12 Years | BDA MDI (PT027) 160/180 μg | 1,209 | |
| Overall Study | Full Analysis Set; >=12 Years | AS MDI (PT007) 180 µg | 1,212 | |
| Overall Study | Full Analysis Set; >=18 Years | BDA MDI (PT027) 160/180 μg | 1,180 | |
| Overall Study | Full Analysis Set; >=18 Years | AS MDI (PT007) 180 µg | 1,173 | |
| Overall Study | COMPLETED | BDA MDI (PT027) 160/180 μg | 903 | |
| Overall Study | COMPLETED | AS MDI (PT007) 180 µg | 894 | |
| Overall Study | NOT COMPLETED | BDA MDI (PT027) 160/180 μg | 354 | |
| Overall Study | NOT COMPLETED | AS MDI (PT007) 180 µg | 365 |
Source ClinicalTrials.gov
Adverse events166
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Upper respiratory tract infection | Infections and infestations | BDA MDI (PT027) 160/180 μg | 65 | 1,209 | 74 |
| other | Upper respiratory tract infection | Infections and infestations | AS MDI (PT007) 180 µg | 73 | 1,212 | 80 |
| other | COVID-19 | Infections and infestations | BDA MDI (PT027) 160/180 μg | 62 | 1,209 | 63 |
| other | COVID-19 | Infections and infestations | AS MDI (PT007) 180 µg | 67 | 1,212 | 69 |
| other | Nasopharyngitis | Infections and infestations | BDA MDI (PT027) 160/180 μg | 45 | 1,209 | 46 |
| other | Nasopharyngitis | Infections and infestations | AS MDI (PT007) 180 µg | 32 | 1,212 | 34 |
| other | Sinusitis | Infections and infestations | BDA MDI (PT027) 160/180 μg | 38 | 1,209 | 41 |
| other | Sinusitis | Infections and infestations | AS MDI (PT007) 180 µg | 30 | 1,212 | 36 |
| other | Bronchitis | Infections and infestations | BDA MDI (PT027) 160/180 μg | 29 | 1,209 | 30 |
| other | Bronchitis | Infections and infestations | AS MDI (PT007) 180 µg | 32 | 1,212 | 36 |
1 to 10 of 166Source ClinicalTrials.gov
See all 166 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BDA MDI (PT027) 160/180 μg | 2 | 1,257 |
| Total, all-cause mortality | AS MDI (PT007) 180 µg | 1 | 1,259 |
| Total, other adverse events | BDA MDI (PT027) 160/180 μg | 227 | 1,209 |
| Total, other adverse events | AS MDI (PT007) 180 µg | 232 | 1,212 |
| Total, serious adverse events | BDA MDI (PT027) 160/180 μg | 37 | 1,209 |
| Total, serious adverse events | AS MDI (PT007) 180 µg | 37 | 1,212 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40388330 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| BDA MDI (PT027) 160/180 μg vs AS MDI (PT007) 180 µg: Time to First Severe Asthma Exacerbation, While on Treatment Strategy (Participants Aged >=18 Years) | Trial comparisons |
| BDA MDI (PT027) 160/180 μg vs AS MDI (PT007) 180 µg: Time to First Severe Asthma Exacerbation, Treatment Policy Strategy, Interim Analysis Data Cut-off (Participants Aged >=12 Years) | Trial comparisons |
| BDA MDI (PT027) 160/180 μg vs AS MDI (PT007) 180 µg: Time to First Severe Asthma Exacerbation, Treatment Policy Strategy (Participants Aged >=18 Years) | Trial comparisons |
| BDA MDI (PT027) 160/180 μg vs AS MDI (PT007) 180 µg: Time to First Severe Asthma Exacerbation, While on Treatment Strategy, Interim Analysis Data Cut-off (Participants Aged >=12 Years) | Trial comparisons |
| BDA MDI (PT027) 160/180 μg vs AS MDI (PT007) 180 µg: deaths from any cause | Trial comparisons |
| BDA MDI (PT027) 160/180 μg vs AS MDI (PT007) 180 µg: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05505734
GET https://conductscience.org/api/trials/v1/NCT05505734/events?page=2