CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 15 enrolled
Drug / intervention
Aspirin +2 moredrug
Likely dose
Aspirin 81mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03008915
NCT03008915Phase 2Completed
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Targeting Pulmonary Perfusion in Alpha-1 Antitrypsin Deficiency

Columbia University·interventional·Posted Jan 4, 2017·Updated Feb 17, 2021

In Brief

A Phase 2 clinical trial evaluating Aspirin, Placebo, and 1 other intervention for Alpha-1 Antitrypsin Deficiency and 2 related conditions. Completed, enrolled 15 participants across 1 site.

Detailed Summary

The aim of this study is to test whether aspirin improves endothelial function in alpha-1 antitrypsin deficiency-associated lung disease, measured by pulmonary microvascular blood flow on magnetic resonance imaging (MRI) and with apoptotic endothelial microparticles.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlpha-1 Antitrypsin Deficiency, Emphysema, Chronic Obstructive Pulmonary Disease
CountriesUnited States
CollaboratorsAlpha-1 Foundation, Stony Wold-Herbert Fund, Inc.

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 4, 2017
Enrollment StartJan 1, 2017
Primary CompletionJul 1, 2018
Study CompletionOct 1, 2020
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 9.5 years ago

Interventions

Aspirindrug

81mg aspirin taken once per day in the morning

Placebodrug

placebo taken once per day in the morning

Withdrawal from alpha1 antitrypsin replacement therapyother

After the completion of the randomization to aspirin and placebo, participants who are on alpha1 replacement therapy are asked to withhold their usual alpha1 antitrypsin replacement therapy for 5 weeks. This is not randomized.