Phase 2
N=15
Targeting Pulmonary Perfusion in Alpha-1 Antitrypsin Deficiency
Alpha-1 Antitrypsin Deficiency · Emphysema · Chronic Obstructive Pulmonary Disease
Bottom Line
View on ClinicalTrials.gov: NCT03008915 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Pulmonary Microvascular Blood Flow, Mean — 36.9; 35.1 mL blood/minute per 100mL lung — p=0.692
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Aspirin (Drug); Placebo (Drug); Withdrawal from alpha1 antitrypsin replacement therapy (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pulmonary Microvascular Blood Flow, Mean |
35.5; 35.1 | — |
| SECONDARY Endothelial Microparticles |
996.0; 821.5; 3681.5; 596.0; 146.0; 317.0 | — |
| SECONDARY Endothelial Microparticles |
996.0; 821.5; 3681.5; 596.0; 146.0; 317.0 | — |
| SECONDARY Pulmonary Microvascular Blood Flow, Mean |
35.5; 35.1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Alpha-1 antitrypsin deficiency (PiZZ genotype)
- 40 years of age or older
- Evidence of emphysema on CT scan as read by a Radiologist
Exclusion Criteria
- Platelet count 300 lbs (due to weight limits of the machine), those with pacemakers, aneurysm clips, cochlear implants or other implanted electronic devices, or severe claustrophobia;
- Chronic renal insufficiency (estimated GFR < 45 L/min/1.73 m2 or self report) due to slightly increased risk of nephrogenic systemic fibrosis from gadolinium administration and aspirin-related renal insufficiency
- Exacerbation of respiratory symptoms within the previous 6 weeks, such as that requiring hospitalization, oral prednisone or antibiotics to control symptoms.
Data sourced from ClinicalTrials.gov (NCT03008915). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.