Trial · NCT03008915
Targeting Pulmonary Perfusion in Alpha-1 Antitrypsin Deficiency
NCT03008915, Phase 2, Completed, Columbia University; results first posted 2021-02-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Targeting Pulmonary Perfusion in Alpha-1 Antitrypsin Deficiency. Trials, record NCT03008915. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03008915
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Targeting Pulmonary Perfusion in Alpha-1 Antitrypsin Deficiency
- NCT number
- NCT03008915
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- Columbia University
- Conditions
- Alpha-1 Antitrypsin Deficiency, Emphysema, Chronic Obstructive Pulmonary Disease
- Interventions
- Aspirin, Placebo, Withdrawal from alpha1 antitrypsin replacement therapy
- First posted
- 2017-01-04
- Last updated
- 2021-02-17
- Results first posted
- 2021-02-17
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pulmonary Microvascular Blood Flow, Mean | 2 weeks | Pulmonary microvascular blood flow is measured on contrast-enhanced MRI, limited to blood flow in the 2cm periphery of the lung |
| Secondary | Endothelial Microparticles | 2 weeks | Endothelial microparticles (EMPs) are vesicles shed from endothelial plasma membranes into the circulation in response to endothelial cell perturbation. CD31+ is a measure of apoptotic endothelial microparticles, CD62+ (P-selectin) is a measure of endothelial activation, and Annexin V/CD31+ is a more specific marker of endothelial cell apoptosis. |
| Secondary | Endothelial Microparticles | 5 weeks | Endothelial microparticles (EMPs) are vesicles shed from endothelial plasma membranes into the circulation in response to endothelial cell perturbation. CD31+ is a measure of apoptotic endothelial microparticles, CD62+ (P-selectin) is a measure of endothelial activation, and Annexin V/CD31+ is a more specific marker of endothelial cell apoptosis. |
| Secondary | Pulmonary Microvascular Blood Flow, Mean | 5 weeks | Pulmonary microvascular blood flow is measured on contrast-enhanced MRI in the peripheral 2cm of the lung. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pulmonary Microvascular Blood Flow, Mean | 2 weeks | Due to errors in acquisition of MRI, a number of participants had uninterpretable scans. 13 participants had MRIs interpretable for PMBF on placebo, and 7 on aspirin. Altogether, there were 6 participants with paired results from the two scans. | mL blood/minute per 100mL lung | MEAN |
| SECONDARY | Endothelial Microparticles | 2 weeks | Due to lab closure and technician availability, only the first 3 participants had EMPs measured. | EMPs/uL | MEAN |
| SECONDARY | Endothelial Microparticles | 5 weeks | Only 2 participants had EMPs measured on placebo and 2 off AAT replacement therapy, only 1 participant had EMPs measured at both time points. | EMPs/uL | MEAN |
| SECONDARY | Pulmonary Microvascular Blood Flow, Mean | 5 weeks | 2 participants who completed the withdrawal phase had MRIs interpretable for PMBF on placebo and off AAT replacement therapy, data for the other 2 participants was uninterpretable for at least 1 of the 2 scans. | mL blood/minute per 100mL lung | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pulmonary Microvascular Blood Flow, Mean | Aspirin | 36.9 | Standard Deviation 13.0 | mL blood/minute per 100mL lung | |
| Pulmonary Microvascular Blood Flow, Mean | Placebo | 35.1 | Standard Deviation 15.4 | mL blood/minute per 100mL lung | |
| Endothelial Microparticles | Aspirin | CD31+ | 749.0 | Standard Deviation 231.1 | EMPs/uL |
| Endothelial Microparticles | Placebo | CD31+ | 821.5 | Standard Deviation 3.5 | EMPs/uL |
| Endothelial Microparticles | Aspirin | CD62+ | 1357.3 | Standard Deviation 469.6 | EMPs/uL |
| Endothelial Microparticles | Placebo | CD62+ | 596 | Standard Deviation 287.1 | EMPs/uL |
| Endothelial Microparticles | Aspirin | Annexin V, CD31+ | 145.0 | Standard Deviation 62.8 | EMPs/uL |
| Endothelial Microparticles | Placebo | Annexin V, CD31+ | 317.0 | Standard Deviation 210.7 | EMPs/uL |
| Endothelial Microparticles | Off Alpha-1 Replacement Therapy | CD31+ | 996.0 | Standard Deviation 408.7 | EMPs/uL |
| Endothelial Microparticles | Placebo | CD31+ | 821.5 | Standard Deviation 3.5 | EMPs/uL |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment 1 | STARTED | Aspirin First, Then Placebo | 8 | |
| Treatment 1 | STARTED | Placebo First, Then Aspirin | 7 | |
| Treatment 1 | COMPLETED | Aspirin First, Then Placebo | 8 | |
| Treatment 1 | COMPLETED | Placebo First, Then Aspirin | 6 | |
| Treatment 1 | NOT COMPLETED | Aspirin First, Then Placebo | 0 | |
| Treatment 1 | NOT COMPLETED | Placebo First, Then Aspirin | 1 | |
| Treatment 2 | STARTED | Aspirin First, Then Placebo | 8 | |
| Treatment 2 | STARTED | Placebo First, Then Aspirin | 6 | |
| Treatment 2 | COMPLETED | Aspirin First, Then Placebo | 8 | |
| Treatment 2 | COMPLETED | Placebo First, Then Aspirin | 6 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events2
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 | Syncope | Vascular disorders | Aspirin | 0 | 14 | 0 |
| other | Syncope | Vascular disorders | Placebo | 1 | 15 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aspirin | 0 | 14 |
| Total, all-cause mortality | Placebo | 0 | 15 |
| Total, other adverse events | Aspirin | 0 | 14 |
| Total, other adverse events | Placebo | 1 | 15 |
| Total, serious adverse events | Aspirin | 0 | 14 |
| Total, serious adverse events | Placebo | 0 | 15 |
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 |
|---|---|
| Aspirin vs Placebo: deaths from any cause | Trial comparisons |
| Aspirin vs Placebo: 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/NCT03008915
GET https://conductscience.org/api/trials/v1/NCT03008915/registered