Targeting Pulmonary Perfusion in Alpha-1 Antitrypsin Deficiency

Status Completed

Clinical Trial 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.

Clinical Trial Description

Emphysema is a common type of lung disease in patients with alpha-1 antitrypsin deficiency (AATD). Emphysema refers to destruction of the fine network of air spaces and blood vessels in the lung, and results in what looks like "holes" in the lung. Emphysema is associated with an increased risk of death but currently no medications, except for replacement of alpha-1 antitrypsin (AAT), have been shown to treat emphysema. The study plans to enroll subjects with alpha-1 antitrypsin deficiency-associated lung disease (PiZZ phenotype) to perform a cross-over randomized controlled trial (RCT) of aspirin compared to placebo to test the hypotheses that aspirin is effective in improving blood flow in the lungs and reducing damage to the endothelial cells. Subjects will be randomized to receive aspirin or placebo for 2 weeks. There will be a 2-week washout period, then the participant will be crossed over to receive the other treatment (those who received aspirin first will receive the placebo and those who received the placebo first will receive aspirin). Participants who are on alpha-1 replacement therapy who have had fewer than 2 exacerbations in the last year will be asked whether they are interested in a withdrawal study. For this second part of the study, eligible and willing participants will be asked to stop their alpha-1 replacement therapy for 5 weeks and come in for a 4th study visit. This will allow AAT levels to drop briefly to those seen in the absence of AAT augmentation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03008915
Study type	Interventional
Source	Columbia University
Contact
Status	Completed
Phase	Phase 2
Start date	January 2017
Completion date	October 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05102305` - A Multi-center,Prospective, OS to Evaluate the Effectiveness of 'NAC' Nebulizer Therapy in COPD (NEWEST)
Completed	`NCT01867762` - An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease	Phase 2
Recruiting	`NCT05562037` - Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA	N/A
Terminated	`NCT04921332` - Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD	N/A
Completed	`NCT03089515` - Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust	N/A
Completed	`NCT02787863` - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology	Phase 4
Recruiting	`NCT05552833` - Pulmonary Adaptive Responses to HIIT in COPD	N/A
Recruiting	`NCT05835492` - A Pragmatic Real-world Multicentre Observational Research Study to Explore the Clinical and Health Economic Impact of myCOPD
Recruiting	`NCT05631132` - May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases?	N/A
Completed	`NCT03244137` - Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
Not yet recruiting	`NCT03282526` - Volume Parameters vs Flow Parameters in Assessment of Reversibility in Chronic Obstructive Pulmonary Disease	N/A
Completed	`NCT02546700` - A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD)	Phase 2
Withdrawn	`NCT04446637` - Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination vs Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol Free Combination in Patients With Stable COPD	Phase 3
Completed	`NCT04535986` - A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD	Phase 3
Recruiting	`NCT05865184` - Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
Completed	`NCT03295474` - Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.
Completed	`NCT03256695` - Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD)	Phase 3
Withdrawn	`NCT04042168` - Implications of Appropriate Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD)	Phase 4
Completed	`NCT03414541` - Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease	Phase 2
Completed	`NCT02552160` - DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy