PT027 Compared to PT007 in Patients With Asthma With Mannitol-induced Acute Airway Obstruction
Summary
A study evaluating efficacy and safety of repeated doses of PT027 compared to PT007 in patients with asthma and acute airway obstruction induced by repeated mannitol challenges
Timeline
- Start
- 2022-09-28
- Primary completion
- 2024-11-18
- Completion
- 2024-11-18
Outcome
Mixed primary results
registry The primary efficacy comparison of non-inferiority of PT027 versus PT007 evaluated the while-on treatment estimand in the Per Protocol (PP) analysis set and was based on a 1-sided hypothesis testing approach with a non-inferiority margin of -150 mL. NCT05555290 ↗
registry analysis (non-inferiority test); Treatment A (PT027) [Experimental] vs Treatment B (PT007) [Active Comparator]; Difference in least squares means -6.24 (95% CI -60.52 to 48.04) NCT05555290 ↗
registry analysis (superiority test); Treatment A (PT027) [Experimental] vs Treatment B (PT007) [Active Comparator]; p = 0.762; Difference in least squares means -7.71 (95% CI -61.95 to 46.54); Linear mixed effects model NCT05555290 ↗
registry The primary efficacy comparison of non-inferiority of PT027 versus PT007 evaluated the while-on-treatment estimand in the PP analysis set and was based on a 1-sided hypothesis testing approach with a non-inferiority margin of -150 mL. NCT05555290 ↗
registry analysis (non-inferiority test); Treatment A (PT027) [Experimental] vs Treatment B (PT007) [Active Comparator]; Difference in least squares means -9.14 (95% CI -55.53 to 37.25) NCT05555290 ↗
registry analysis (superiority test); Treatment A (PT027) [Experimental] vs Treatment B (PT007) [Active Comparator]; p = 0.257; Difference in least squares means -25.78 (95% CI -70.77 to 19.20); Linear mixed effects model NCT05555290 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Budesonide | Small molecule | — | Inhaled |
| Background | Salbutamol | Unknown | — | Inhaled |