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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | Up 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. |
| Primary | Part 1: Change From Mannitol Baseline FEV1 AUC (0-60 Min) Post-mannitol Challenge 1 - Superiority Analysis | Up 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. |
| Primary | Part 2: Change From Mannitol Baseline FEV1 AUC (0-60 Min) Post-mannitol Challenge 1 - Non-Inferiority Analysis | Up 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. |
| Primary | Part 2: Change From Mannitol Baseline FEV1 AUC (0-60 Min) Post-mannitol Challenge 1 - Superiority Analysis | Up 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. |
| Secondary | Part 1: Change From Mannitol Baseline in FEV1 AUC (0-15 Min) Post-mannitol Challenge 1 - Non-Inferiority Analysis | Up 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. |
| Secondary | Part 1: Change From Mannitol Baseline in FEV1 AUC (0-15 Min) Post-mannitol Challenge 1 - Superiority Analysis | Up 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. |
| Secondary | Part 2: Change From Mannitol Baseline in FEV1 AUC (0-15 Min) Post-mannitol Challenge 1 - Non-Inferiority Analysis | Up 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. |
| Secondary | Part 2: Change From Mannitol Baseline in FEV1 AUC (0-15 Min) Post-mannitol Challenge 1 - Superiority Analysis | Up 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. |
| Secondary | Part 1: Change From Mannitol Baseline in FEV1 at 7 Hours Post-mannitol Challenge 1 - Non-Inferiority Analysis | At 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. |
| Secondary | Part 1: Change From Mannitol Baseline in FEV1 at 7 Hours Post-mannitol Challenge 1 - Superiority Analysis | At 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. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | Up 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 |
| PRIMARY | Part 1: Change From Mannitol Baseline FEV1 AUC (0-60 Min) Post-mannitol Challenge 1 - Superiority Analysis | Up 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 |
| PRIMARY | Part 2: Change From Mannitol Baseline FEV1 AUC (0-60 Min) Post-mannitol Challenge 1 - Non-Inferiority Analysis | Up 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 |
| PRIMARY | Part 2: Change From Mannitol Baseline FEV1 AUC (0-60 Min) Post-mannitol Challenge 1 - Superiority Analysis | Up 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 |
| SECONDARY | Part 1: Change From Mannitol Baseline in FEV1 AUC (0-15 Min) Post-mannitol Challenge 1 - Non-Inferiority Analysis | Up 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 |
| SECONDARY | Part 1: Change From Mannitol Baseline in FEV1 AUC (0-15 Min) Post-mannitol Challenge 1 - Superiority Analysis | Up 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 |
| SECONDARY | Part 2: Change From Mannitol Baseline in FEV1 AUC (0-15 Min) Post-mannitol Challenge 1 - Non-Inferiority Analysis | Up 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 |
| SECONDARY | Part 2: Change From Mannitol Baseline in FEV1 AUC (0-15 Min) Post-mannitol Challenge 1 - Superiority Analysis | Up 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 |
| SECONDARY | Part 1: Change From Mannitol Baseline in FEV1 at 7 Hours Post-mannitol Challenge 1 - Non-Inferiority Analysis | At 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 |
| SECONDARY | Part 1: Change From Mannitol Baseline in FEV1 at 7 Hours Post-mannitol Challenge 1 - Superiority Analysis | At 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 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Treatment A (PT027) [Experimental] | 638.7 | Standard Deviation 206.4 | milliliters (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 Analysis | Treatment B (PT007) [Active Comparator] | 657.9 | Standard Deviation 284.4 | milliliters (mL) | |
| Part 1: Change From Mannitol Baseline FEV1 AUC (0-60 Min) Post-mannitol Challenge 1 - Superiority Analysis | Treatment A (PT027) [Experimental] | 624.2 | Standard Deviation 207.6 | milliliters (mL) | |
| Part 1: Change From Mannitol Baseline FEV1 AUC (0-60 Min) Post-mannitol Challenge 1 - Superiority Analysis | Treatment B (PT007) [Active Comparator] | 657.9 | Standard Deviation 284.4 | milliliters (mL) | |
| Part 2: Change From Mannitol Baseline FEV1 AUC (0-60 Min) Post-mannitol Challenge 1 - Non-Inferiority Analysis | Treatment A (PT027) [Experimental] | 749.7 | Standard Deviation 347.0 | milliliters (mL) | |
| Part 2: Change From Mannitol Baseline FEV1 AUC (0-60 Min) Post-mannitol Challenge 1 - Non-Inferiority Analysis | Treatment B (PT007) [Active Comparator] | 758.1 | Standard Deviation 342.3 | milliliters (mL) | |
| Part 2: Change From Mannitol Baseline FEV1 AUC (0-60 Min) Post-mannitol Challenge 1 - Superiority Analysis | Treatment A (PT027) [Experimental] | 688.6 | Standard Deviation 342.3 | milliliters (mL) | |
| Part 2: Change From Mannitol Baseline FEV1 AUC (0-60 Min) Post-mannitol Challenge 1 - Superiority Analysis | Treatment B (PT007) [Active Comparator] | 716.9 | Standard Deviation 348.3 | milliliters (mL) | |
| Part 1: Change From Mannitol Baseline in FEV1 AUC (0-15 Min) Post-mannitol Challenge 1 - Non-Inferiority Analysis | Treatment A (PT027) [Experimental] | 372.3 | Standard Deviation 156.9 | milliliters (mL) | |
| Part 1: Change From Mannitol Baseline in FEV1 AUC (0-15 Min) Post-mannitol Challenge 1 - Non-Inferiority Analysis | Treatment B (PT007) [Active Comparator] | 391.4 | Standard Deviation 235.7 | milliliters (mL) |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1 | STARTED | Treatment A (PT027) [Experimental], Then Treatment B (PT007) [Active Comparator] Part 1 & 2 | 8 | |
| Part 1 | STARTED | Treatment B (PT007) [Active Comparator], Then Treatment A (PT027) [Experimental] Part 1 & 2 | 9 | |
| Part 1 | COMPLETED | Treatment A (PT027) [Experimental], Then Treatment B (PT007) [Active Comparator] Part 1 & 2 | 7 | |
| Part 1 | COMPLETED | Treatment B (PT007) [Active Comparator], Then Treatment A (PT027) [Experimental] Part 1 & 2 | 8 | |
| Part 1 | NOT COMPLETED | Treatment A (PT027) [Experimental], Then Treatment B (PT007) [Active Comparator] Part 1 & 2 | 1 | |
| Part 1 | NOT COMPLETED | Treatment B (PT007) [Active Comparator], Then Treatment A (PT027) [Experimental] Part 1 & 2 | 1 | |
| Part 2 | STARTED | Treatment A (PT027) [Experimental], Then Treatment B (PT007) [Active Comparator] Part 1 & 2 | 44 | |
| Part 2 | STARTED | Treatment B (PT007) [Active Comparator], Then Treatment A (PT027) [Experimental] Part 1 & 2 | 44 | |
| Part 2 | COMPLETED | Treatment A (PT027) [Experimental], Then Treatment B (PT007) [Active Comparator] Part 1 & 2 | 41 | |
| Part 2 | COMPLETED | Treatment B (PT007) [Active Comparator], Then Treatment A (PT027) [Experimental] Part 1 & 2 | 40 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events20
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | COVID-19 | Infections and infestations | Treatment A (PT027) [Experimental] | 1 | 100 | |
| other | COVID-19 | Infections and infestations | Treatment B (PT007) [Active Comparator] | 0 | 101 | |
| other | Influenza | Infections and infestations | Treatment A (PT027) [Experimental] | 0 | 100 | |
| other | Influenza | Infections and infestations | Treatment B (PT007) [Active Comparator] | 1 | 101 | |
| other | Sinusitis | Infections and infestations | Treatment A (PT027) [Experimental] | 1 | 100 | |
| other | Sinusitis | Infections and infestations | Treatment B (PT007) [Active Comparator] | 0 | 101 | |
| other | Upper respiratory tract infection | Infections and infestations | Treatment A (PT027) [Experimental] | 0 | 100 | |
| other | Upper respiratory tract infection | Infections and infestations | Treatment B (PT007) [Active Comparator] | 1 | 101 | |
| other | Anxiety | Psychiatric disorders | Treatment A (PT027) [Experimental] | 1 | 100 | |
| other | Anxiety | Psychiatric disorders | Treatment B (PT007) [Active Comparator] | 0 | 101 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment A (PT027) [Experimental] | 0 | 100 |
| Total, all-cause mortality | Treatment B (PT007) [Active Comparator] | 0 | 101 |
| Total, other adverse events | Treatment A (PT027) [Experimental] | 5 | 100 |
| Total, other adverse events | Treatment B (PT007) [Active Comparator] | 4 | 101 |
| Total, serious adverse events | Treatment A (PT027) [Experimental] | 0 | 100 |
| Total, serious adverse events | Treatment B (PT007) [Active Comparator] | 0 | 101 |
Source ClinicalTrials.gov
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.
| Comparison | Source |
|---|---|
| Treatment A (PT027) [Experimental] vs Treatment B (PT007) [Active Comparator]: deaths from any cause | Trial comparisons |
| Treatment A (PT027) [Experimental] vs Treatment B (PT007) [Active Comparator]: serious adverse events | Trial 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.
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