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Trial · NCT05555290

PT027 Compared to PT007 in Patients With Asthma With Mannitol-induced Acute Airway Obstruction

NCT05555290, Phase 3, Completed, AstraZeneca; results first posted 2026-01-27

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. PT027 Compared to PT007 in Patients With Asthma With Mannitol-induced Acute Airway Obstruction. Trials, record NCT05555290. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05555290

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
PT027 Compared to PT007 in Patients With Asthma With Mannitol-induced Acute Airway Obstruction
NCT number
NCT05555290
Status
Completed
Phases
Phase 3
Enrollment
190 participants, actual
Lead sponsor
AstraZeneca
Conditions
Asthma
Interventions
PT027, PT007
First posted
2022-09-26
Last updated
2026-01-27
Results first posted
2026-01-27

Source ClinicalTrials.gov

Registered outcomes24

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPart 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 AnalysisUp to 60 minutes post mannitol challenge 1
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.
PrimaryPart 1: Change From Mannitol Baseline FEV1 AUC (0-60 Min) Post-mannitol Challenge 1 - Superiority AnalysisUp to 60 minutes post mannitol challenge 1
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.
PrimaryPart 2: Change From Mannitol Baseline FEV1 AUC (0-60 Min) Post-mannitol Challenge 1 - Non-Inferiority AnalysisUp to 60 minutes post mannitol challenge 1
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.
PrimaryPart 2: Change From Mannitol Baseline FEV1 AUC (0-60 Min) Post-mannitol Challenge 1 - Superiority AnalysisUp to 60 minutes post mannitol challenge 1
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.
SecondaryPart 1: Change From Mannitol Baseline in FEV1 AUC (0-15 Min) Post-mannitol Challenge 1 - Non-Inferiority AnalysisUp to 15 minutes post mannitol challenge 1
The efficacy of PT027 after a single dose compared with PT007 in reversal of acute airway obstruction, 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 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.
SecondaryPart 1: Change From Mannitol Baseline in FEV1 AUC (0-15 Min) Post-mannitol Challenge 1 - Superiority AnalysisUp to 15 minutes post mannitol challenge 1
The efficacy of PT027 after a single dose compared with PT007 in reversal of acute airway obstruction, 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 RS. Superiority was concluded if the 2-sided p-value was \< 0.05.
SecondaryPart 2: Change From Mannitol Baseline in FEV1 AUC (0-15 Min) Post-mannitol Challenge 1 - Non-Inferiority AnalysisUp to 15 minutes post mannitol challenge 1
The efficacy of PT027 after a single dose compared with PT007 in reversal of acute airway obstruction, 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 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.
SecondaryPart 2: Change From Mannitol Baseline in FEV1 AUC (0-15 Min) Post-mannitol Challenge 1 - Superiority AnalysisUp to 15 minutes post mannitol challenge 1
The efficacy of PT027 after a single dose compared with PT007 in reversal of acute airway obstruction, 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 mRS. Superiority was concluded if the 2-sided p-value was \< 0.05.
SecondaryPart 1: Change From Mannitol Baseline in FEV1 at 7 Hours Post-mannitol Challenge 1 - Non-Inferiority AnalysisAt 7 hours post mannitol challenge 1
The efficacy of PT027 compared with PT007 in the sustainability of effect of reversal of acute airway obstruction post-mannitol challenge 1 in 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 is 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 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.
SecondaryPart 1: Change From Mannitol Baseline in FEV1 at 7 Hours Post-mannitol Challenge 1 - Superiority AnalysisAt 7 hours post mannitol challenge 1
The efficacy of PT027 compared with PT007 in the sustainability of effect of reversal of acute airway obstruction post-mannitol challenge 1 in 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 RS. Superiority was concluded if the 2-sided p-value was \< 0.05.

Outcomes24

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPart 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 AnalysisUp to 60 minutes post mannitol challenge 1
PP analysis set included all participants who received all doses of study treatment following mannitol challenge 1, had baseline and post-treatment study evaluation (spirometry tests), and did not have any important protocol deviations. Challenge 1 referred to the first mannitol challenge for Visits 2 and 3.
milliliters (mL)MEAN
PRIMARYPart 1: Change From Mannitol Baseline FEV1 AUC (0-60 Min) Post-mannitol Challenge 1 - Superiority AnalysisUp to 60 minutes post mannitol challenge 1
RS included all participants who were randomized to any of the 2 treatment sequences, A/B or B/A.~Treatments A and B were defined as:~Treatment A = PT027 180/160 µg pressurized metered dose inhaler (pMDI) Treatment B = PT007 180 µg pMDI
milliliters (mL)MEAN
PRIMARYPart 2: Change From Mannitol Baseline FEV1 AUC (0-60 Min) Post-mannitol Challenge 1 - Non-Inferiority AnalysisUp to 60 minutes post mannitol challenge 1
PP analysis set included all participants who received all doses of study treatment following mannitol challenge 1, had baseline and post-treatment study evaluation (spirometry tests), and did not have any important protocol deviations. Challenge 1 referred to the first mannitol challenge for Visits 2 and 3.
milliliters (mL)MEAN
PRIMARYPart 2: Change From Mannitol Baseline FEV1 AUC (0-60 Min) Post-mannitol Challenge 1 - Superiority AnalysisUp to 60 minutes post mannitol challenge 1
mRS included all participants who were randomized to any of the 2 treatment sequences, A/B or B/A and received any amount of randomized study treatment.~Treatments A and B were defined as:~Treatment A = PT027 180/160 µg pMDI Treatment B = PT007 180 µg pMDI
milliliters (mL)MEAN
SECONDARYPart 1: Change From Mannitol Baseline in FEV1 AUC (0-15 Min) Post-mannitol Challenge 1 - Non-Inferiority AnalysisUp to 15 minutes post mannitol challenge 1
PP analysis set included all participants who received all doses of study treatment following mannitol challenge 1, had baseline and post-treatment study evaluation (spirometry tests), and did not have any important protocol deviations. Challenge 1 referred to the first mannitol challenge for Visits 2 and 3.
milliliters (mL)MEAN
SECONDARYPart 1: Change From Mannitol Baseline in FEV1 AUC (0-15 Min) Post-mannitol Challenge 1 - Superiority AnalysisUp to 15 minutes post mannitol challenge 1
RS included all participants who were randomized to any of the 2 treatment sequences, A/B or B/A.~Treatments A and B were defined as:~Treatment A = PT027 180/160 µg pMDI Treatment B = PT007 180 µg pMDI
milliliters (mL)MEAN
SECONDARYPart 2: Change From Mannitol Baseline in FEV1 AUC (0-15 Min) Post-mannitol Challenge 1 - Non-Inferiority AnalysisUp to 15 minutes post mannitol challenge 1
PP analysis set included all participants who received all doses of study treatment following mannitol challenge 1, had baseline and post-treatment study evaluation (spirometry tests), and did not have any important protocol deviations. Challenge 1 referred to the first mannitol challenge for Visits 2 and 3.
milliliters (mL)MEAN
SECONDARYPart 2: Change From Mannitol Baseline in FEV1 AUC (0-15 Min) Post-mannitol Challenge 1 - Superiority AnalysisUp to 15 minutes post mannitol challenge 1
mRS included all participants who were randomized to any of the 2 treatment sequences, A/B or B/A and received any amount of randomized study treatment.~Treatments A and B were defined as:~Treatment A = PT027 180/160 µg pMDI Treatment B = PT007 180 µg pMDI
milliliters (mL)MEAN
SECONDARYPart 1: Change From Mannitol Baseline in FEV1 at 7 Hours Post-mannitol Challenge 1 - Non-Inferiority AnalysisAt 7 hours post mannitol challenge 1
PP analysis set included all participants who received all doses of study treatment following mannitol challenge 1, had baseline and post-treatment study evaluation (spirometry tests), and did not have any important protocol deviations. Challenge 1 referred to the first mannitol challenge for Visits 2 and 3.
milliliters (mL)MEAN
SECONDARYPart 1: Change From Mannitol Baseline in FEV1 at 7 Hours Post-mannitol Challenge 1 - Superiority AnalysisAt 7 hours post mannitol challenge 1
RS included all participants who were randomized to any of the 2 treatment sequences, A/B or B/A.~Treatments A and B were defined as:~Treatment A = PT027 180/160 µg pMDI Treatment B = PT007 180 µg pMDI
milliliters (mL)MEAN

Results by group56

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
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 AnalysisTreatment A (PT027) [Experimental]638.7Standard Deviation 206.4milliliters (mL)
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 AnalysisTreatment B (PT007) [Active Comparator]657.9Standard Deviation 284.4milliliters (mL)
Part 1: Change From Mannitol Baseline FEV1 AUC (0-60 Min) Post-mannitol Challenge 1 - Superiority AnalysisTreatment A (PT027) [Experimental]624.2Standard Deviation 207.6milliliters (mL)
Part 1: Change From Mannitol Baseline FEV1 AUC (0-60 Min) Post-mannitol Challenge 1 - Superiority AnalysisTreatment B (PT007) [Active Comparator]657.9Standard Deviation 284.4milliliters (mL)
Part 2: Change From Mannitol Baseline FEV1 AUC (0-60 Min) Post-mannitol Challenge 1 - Non-Inferiority AnalysisTreatment A (PT027) [Experimental]749.7Standard Deviation 347.0milliliters (mL)
Part 2: Change From Mannitol Baseline FEV1 AUC (0-60 Min) Post-mannitol Challenge 1 - Non-Inferiority AnalysisTreatment B (PT007) [Active Comparator]758.1Standard Deviation 342.3milliliters (mL)
Part 2: Change From Mannitol Baseline FEV1 AUC (0-60 Min) Post-mannitol Challenge 1 - Superiority AnalysisTreatment A (PT027) [Experimental]688.6Standard Deviation 342.3milliliters (mL)
Part 2: Change From Mannitol Baseline FEV1 AUC (0-60 Min) Post-mannitol Challenge 1 - Superiority AnalysisTreatment B (PT007) [Active Comparator]716.9Standard Deviation 348.3milliliters (mL)
Part 1: Change From Mannitol Baseline in FEV1 AUC (0-15 Min) Post-mannitol Challenge 1 - Non-Inferiority AnalysisTreatment A (PT027) [Experimental]372.3Standard Deviation 156.9milliliters (mL)
Part 1: Change From Mannitol Baseline in FEV1 AUC (0-15 Min) Post-mannitol Challenge 1 - Non-Inferiority AnalysisTreatment B (PT007) [Active Comparator]391.4Standard Deviation 235.7milliliters (mL)

Participant flow12

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Part 1STARTEDTreatment A (PT027) [Experimental], Then Treatment B (PT007) [Active Comparator] Part 1 & 28
Part 1STARTEDTreatment B (PT007) [Active Comparator], Then Treatment A (PT027) [Experimental] Part 1 & 29
Part 1COMPLETEDTreatment A (PT027) [Experimental], Then Treatment B (PT007) [Active Comparator] Part 1 & 27
Part 1COMPLETEDTreatment B (PT007) [Active Comparator], Then Treatment A (PT027) [Experimental] Part 1 & 28
Part 1NOT COMPLETEDTreatment A (PT027) [Experimental], Then Treatment B (PT007) [Active Comparator] Part 1 & 21
Part 1NOT COMPLETEDTreatment B (PT007) [Active Comparator], Then Treatment A (PT027) [Experimental] Part 1 & 21
Part 2STARTEDTreatment A (PT027) [Experimental], Then Treatment B (PT007) [Active Comparator] Part 1 & 244
Part 2STARTEDTreatment B (PT007) [Active Comparator], Then Treatment A (PT027) [Experimental] Part 1 & 244
Part 2COMPLETEDTreatment A (PT027) [Experimental], Then Treatment B (PT007) [Active Comparator] Part 1 & 241
Part 2COMPLETEDTreatment B (PT007) [Active Comparator], Then Treatment A (PT027) [Experimental] Part 1 & 240

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherCOVID-19Infections and infestationsTreatment A (PT027) [Experimental]1100
otherCOVID-19Infections and infestationsTreatment B (PT007) [Active Comparator]0101
otherInfluenzaInfections and infestationsTreatment A (PT027) [Experimental]0100
otherInfluenzaInfections and infestationsTreatment B (PT007) [Active Comparator]1101
otherSinusitisInfections and infestationsTreatment A (PT027) [Experimental]1100
otherSinusitisInfections and infestationsTreatment B (PT007) [Active Comparator]0101
otherUpper respiratory tract infectionInfections and infestationsTreatment A (PT027) [Experimental]0100
otherUpper respiratory tract infectionInfections and infestationsTreatment B (PT007) [Active Comparator]1101
otherAnxietyPsychiatric disordersTreatment A (PT027) [Experimental]1100
otherAnxietyPsychiatric disordersTreatment B (PT007) [Active Comparator]0101

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityTreatment A (PT027) [Experimental]0100
Total, all-cause mortalityTreatment B (PT007) [Active Comparator]0101
Total, other adverse eventsTreatment A (PT027) [Experimental]5100
Total, other adverse eventsTreatment B (PT007) [Active Comparator]4101
Total, serious adverse eventsTreatment A (PT027) [Experimental]0100
Total, serious adverse eventsTreatment B (PT007) [Active Comparator]0101

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource
Treatment A (PT027) [Experimental] vs Treatment B (PT007) [Active Comparator]: deaths from any causeTrial comparisons
Treatment A (PT027) [Experimental] vs Treatment B (PT007) [Active Comparator]: serious adverse eventsTrial 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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT05555290

GET https://conductscience.org/api/trials/v1/NCT05555290/registered?page=2