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Targeting Pulmonary Perfusion in Alpha-1 Antitrypsin Deficiency

NCT03008915 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-02-17

Study results available
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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.

Conditions

Interventions

DRUG

Aspirin

81mg aspirin taken once per day in the morning

DRUG

Placebo

placebo taken once per day in the morning

OTHER

Withdrawal from alpha1 antitrypsin replacement therapy

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.

Sponsors & Collaborators

  • Alpha-1 Foundation

    collaborator OTHER

  • Stony Wold-Herbert Fund, Inc.

    collaborator OTHER

  • Columbia University

    lead OTHER

Principal Investigators

  • Carrie Aaron, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-07-31
Completion
2020-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03008915 on ClinicalTrials.gov