Comparison · NCT05505734-1657e057
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)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. 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, record NCT05505734-1657e057. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05505734-1657e057
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0529 | 0.0417 | 0.067 | wilson | |
| Risk in group 2 | 0.0941 | 0.0789 | 0.112 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0411 | -0.0621 | -0.0204 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.563 | 0.419 | 0.756 | log | |
| Odds ratio, group 1 over group 2 | 0.538 | 0.392 | 0.739 | log | |
| Number needed to treat, for one fewer participant with the outcome on BDA MDI (PT027) 160/180 μg than on AS MDI (PT007) 180 µg | 24.3 | 16.1 | 49 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | BDA MDI (PT027) 160/180 μg | Budesonide/albuterol sulfate, BDA MDI, PT027~Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg: Budesonide/albuterol sulfate combination inhalation aerosol | 64 | 1,209 | OG000 |
| Group 2 | AS MDI (PT007) 180 µg | Albuterol sulfate MDI, PT007~Albuterol sulfate metered-dose inhaler 180 μg: Albuterol sulfate inhalation aerosol | 114 | 1,212 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Time to First Severe Asthma Exacerbation, Treatment Policy Strategy, Interim Analysis Data Cut-off (Participants Aged >=12 Years)
- Description
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.
- Population
- Full analysis set; \>=12 years
Source ClinicalTrials.gov
Trial
- Title
- A Comparison of PT027 vs PT007 Used as Needed in Participants With Asthma
- NCT number
- NCT05505734
- Phases
- PHASE3
- Conditions
- Asthma
- Interventions
- BDA MDI, AS MDI
- Lead sponsor
- Bond Avillion 2 Development LP
- Results first posted
- 2025-08-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05505734?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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