Phase 3
N=17
PT027 Compared to PT007 in Patients With Asthma With Mannitol-induced Acute Airway Obstruction
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT05555290 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Part 1: Change From Mannitol Baseline Forced Expiratory Volume in the First Second (FEV1) Area Under the Curve (AUC [0-60 Min]) Post-mannitol Challenge 1 - Non-Inferiority Analysis — 638.7; 657.9 milliliters (mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PT027 (Combination_product); PT007 (Combination_product)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1: Change From Mannitol Baseline Forced Expiratory Volume in the First Second (FEV1) Area Under the Curve (AUC [0-60 Min]) Post-mannitol Challenge 1 - Non-Inferiority Analysis |
638.7; 657.9 | — |
| PRIMARY Part 1: Change From Mannitol Baseline FEV1 AUC (0-60 Min) Post-mannitol Challenge 1 - Superiority Analysis |
624.2; 657.9 | 0.762 |
| PRIMARY Part 2: Change From Mannitol Baseline FEV1 AUC (0-60 Min) Post-mannitol Challenge 1 - Non-Inferiority Analysis |
749.7; 758.1 | — |
| PRIMARY Part 2: Change From Mannitol Baseline FEV1 AUC (0-60 Min) Post-mannitol Challenge 1 - Superiority Analysis |
688.6; 716.9 | 0.257 |
| SECONDARY Part 1: Change From Mannitol Baseline in FEV1 AUC (0-15 Min) Post-mannitol Challenge 1 - Non-Inferiority Analysis |
372.3; 391.4 | — |
| SECONDARY Part 1: Change From Mannitol Baseline in FEV1 AUC (0-15 Min) Post-mannitol Challenge 1 - Superiority Analysis |
367.4; 391.4 | 0.656 |
| SECONDARY Part 2: Change From Mannitol Baseline in FEV1 AUC (0-15 Min) Post-mannitol Challenge 1 - Non-Inferiority Analysis |
476.6; 496.4 | — |
| SECONDARY Part 2: Change From Mannitol Baseline in FEV1 AUC (0-15 Min) Post-mannitol Challenge 1 - Superiority Analysis |
435.8; 469.8 | 0.195 |
| SECONDARY Part 1: Change From Mannitol Baseline in FEV1 at 7 Hours Post-mannitol Challenge 1 - Non-Inferiority Analysis |
680.7; 728.6 | — |
| SECONDARY Part 1: Change From Mannitol Baseline in FEV1 at 7 Hours Post-mannitol Challenge 1 - Superiority Analysis |
662.2; 728.6 | 0.303 |
| SECONDARY Part 2: Change From Mannitol Baseline in FEV1 at 480 Minutes Post-mannitol Challenge 1 - Non-Inferiority Analysis |
765.8; 683.5 | — |
| SECONDARY Part 2: Change From Mannitol Baseline in FEV1 at 480 Minutes Post-mannitol Challenge 1 - Superiority Analysis |
759.9; 684.5 | 0.001 sig |
| SECONDARY Part 1: Time to Return to Baseline (-30 Min) FEV1 Post-mannitol Challenge 2 - Non-Inferiority Analysis |
8.5; 8.0 | — |
| SECONDARY Part 1: Time to Return to Baseline (-30 Min) FEV1 Post-mannitol Challenge 2 - Superiority Analysis |
8.5; 8.0 | 0.514 |
| SECONDARY Part 2: Time to Return to Baseline (-30 Min) FEV1 Post-mannitol Challenge 2, Pre-final Dose of Rescue/Reliever - Non-Inferiority Analysis |
4.5; 4.0 | — |
| SECONDARY Part 2: Time to Return to Baseline (-30 Min) FEV1 Post-mannitol Challenge 2, Pre-final Dose of Rescue/Reliever - Superiority Analysis |
4.5; 4.0 | 0.627 |
| SECONDARY Part 1: Peak Fall in FEV1 From Baseline (-30 Min) FEV1 to Post-mannitol Challenge 2, Pre-dose - Non-Inferiority Analysis |
87.1; 137.7 | — |
| SECONDARY Part 1: Peak Fall in FEV1 From Baseline (-30 Min) FEV1 to Post-mannitol Challenge 2, Pre-dose - Superiority Analysis |
73.4; 137.7 | — |
| SECONDARY Part 2: Peak Fall in FEV1 From Baseline (-30 Min) FEV1 to Post-mannitol Challenge 2, Pre-final Dose of Rescue/Reliever - Non-Inferiority Analysis |
246.2; 283.5 | — |
| SECONDARY Part 2: Peak Fall in FEV1 From Baseline (-30 Min) FEV1 to Post-mannitol Challenge 2, Pre-final Dose of Rescue/Reliever - Superiority Analysis |
246.3; 299.7 | 0.429 |
| SECONDARY Part 1: Peak Fall in FEV1 From 7 Hours to Post-mannitol Challenge 2, Pre-dose - Non-Inferiority Analysis |
207.5; 272.5 | — |
| SECONDARY Part 1: Peak Fall in FEV1 From 7 Hours to Post-mannitol Challenge 2, Pre-dose - Superiority Analysis |
188.9; 272.5 | 0.118 |
| SECONDARY Part 2: Peak Fall in FEV1 From 480 Minutes to Post-mannitol Challenge 2, Pre-final Dose of Rescue/Reliever - Superiority Analysis |
425.0; 378.9 | 0.241 |
| SECONDARY Number of Participants With Adverse Events (AEs) |
5; 4; 0; 0; 0; 0 | — |
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
Eligibility Criteria
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 FEV1 ≥ 1.5 L and FEV1 ≥ 60% to 500 ms), hematology, clinical chemistry, or urinalysis, which in the opinion of the Investigator, may put the participant at risk because of his/her participation in the study, or may influence the results of the study, or the participant's ability to complete entire duration of the study.
- If they are current smokers or participants with smoking history ≥ 10 pack years including the use of vaping products, such as electronic cigarettes, and water pipes. If they are former smokers with a smoking history of <10 pack years, including former vaping or water pipe users, smoking must have stopped for at least 6 months prior to Visit 1 to be eligible.
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and its affiliates and/or staff at the study site and their immediate relative(s)).
- Judgment by the Investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
- Breast feeding, pregnancy or intention to become pregnant during the course of the study.
- Previous randomization in the present study.
Data sourced from ClinicalTrials.gov (NCT05555290). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.