Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PT027 · 1 trial · 1 indication
The efficacy of repeated dosing of PT027 relative to PT007, on post-dose lung function, when used by participants with asthma on SABA as-needed treatment only who are experiencing acute airway obstruction induced by mannitol challenges was assessed. Mannitol baseline was defined as the FEV1 result where a positive response to mannitol was observed prior to dosing of study drug for challenge 1 in Visit 2 and in Visit 3 (time 0). A positive response was defined as a ≥ 15% decrease from the FEV1 determined after the 0 mg mannitol dose up to ≤ 635 mg cumulative mannitol dose. 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.
The efficacy of repeated dosing of PT027 relative to PT007, on post-dose lung function, when used by participants with asthma on SABA as-needed treatment only who are experiencing acute airway obstruction induced by mannitol challenges was assessed. Mannitol baseline was defined as the FEV1 result where a positive response to mannitol was observed prior to dosing of study drug for challenge 1 in Visit 2 and in Visit 3 (time 0). A positive response was defined as a ≥ 15% decrease from the FEV1 determined after the 0 mg mannitol dose up to ≤ 635 mg cumulative mannitol dose. If non-inferiority was demonstrated, then comparisons were made to establish the superiority of PT027 versus PT007. The primary efficacy comparison of superiority was based on a 2-sided hypothesis testing approach in the randomized set (RS). Superiority was concluded if the 2-sided p-value was \< 0.05.
The efficacy of repeated dosing of PT027 relative to PT007, on post-dose lung function, when used by participants with asthma on SABA as-needed treatment only who are experiencing acute airway obstruction induced by mannitol challenges was assessed. Mannitol baseline was defined as the FEV1 result where a positive response to mannitol was observed prior to dosing of study drug for challenge 1 in Visit 2 and in Visit 3 (time 0). A positive response was defined as a ≥ 15% decrease from the FEV1 determined after the 0 mg mannitol dose up to ≤ 635 mg cumulative mannitol dose. 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.
The efficacy of repeated dosing of PT027 relative to PT007, on post-dose lung function, when used by participants with asthma on SABA as-needed treatment only who are experiencing acute airway obstruction induced by mannitol challenges was assessed. Mannitol baseline was defined as the FEV1 result where a positive response to mannitol was observed prior to dosing of study drug for challenge 1 in Visit 2 and in Visit 3 (time 0). A positive response was defined as a ≥ 15% decrease from the FEV1 determined after the 0 mg mannitol dose up to ≤ 635 mg cumulative mannitol dose. If non-inferiority was demonstrated, then comparisons were made to establish the superiority of PT027 versus PT007. The primary efficacy comparison of superiority was based on a 2-sided hypothesis testing approach in the modified randomized set (mRS). Superiority was concluded if the 2-sided p-value was \< 0.05.
| Arm | Type | Description |
|---|---|---|
| Treatment A (PT027) [experimental], then Treatment B (PT007) [active comparator] Part 1 & 2 | EXPERIMENTAL | At Visit 2, participants will receive repeated oral inhalations of PT027 to treat acute airway obstruction induced by a repeated airway challenge, followed by a washout period of 10-14 days. At Visit 3, participants will receive repeated oral inhalations of PT007 to treat acute airway obstruction induced by a repeated airway challenge. |
| Treatment B (PT007) [active comparator], then Treatment A (PT027) [experimental] Part 1 & 2 | EXPERIMENTAL | At Visit 2, participants will receive repeated oral inhalations of PT007 to treat acute airway obstruction induced by a repeated airway challenge, followed by a washout period of 10 to 14 days. At Visit 3, participants will receive repeated oral inhalations of PT027 to treat acute airway obstruction induced by a repeated airway challenge. |
| Name | Type | Description |
|---|---|---|
| PT027 | COMBINATION_PRODUCT | When administered PT027, participants will receive 2 actuations of albuterol- budesonide per dose administered as oral inhalations. |
| PT007 | COMBINATION_PRODUCT | When administered PT007, participants will receive 2 actuations of albuterol administered as oral inhalations. |
Inclusion Criteria: * Participants who have been diagnosed with asthma \> 6 months before Visit 1 by a physician. * Participants must have been prescribed and using as-needed SABA as only asthma treatment for at least 4 weeks before screening visit. * Participants should have pre-bronchodilator FEV...
PT027 is an investigational small molecule being developed for the treatment of asthma. It is currently in Phase 3 clinical development. A completed Phase 3 trial evaluated PT027 compared to PT007 in patients with asthma with mannitol-induced acute airway obstruction.
PT027 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with asthma.
PT027 is in Phase 3 clinical development for asthma. One Phase 3 trial has been completed, which enrolled 190 participants. The drug is investigational and has not yet been approved by regulatory authorities.
PT027 has one completed Phase 3 clinical trial registered as NCT05555290, titled 'PT027 Compared to PT007 in Patients With Asthma With Mannitol-induced Acute Airway Obstruction.' The trial enrolled 190 participants in the United States and was a randomized, double-blind, controlled study.
No, PT027 is not the same as PT007. In the clinical trial NCT05555290, PT027 was compared to PT007 in patients with asthma. The study was designed to evaluate PT027 against PT007, indicating they are distinct investigational treatments.