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AATRU Clinical Trials & Translation Studies

AATRU Lab Staff

Our clinical trials are funded by the NIH and Pharma and focus on understanding the origins of asthma, how we can decrease asthma morbidity and mortality using translational methods and development and testing of new biologics for precision based individualized medicine.

In 2020, we expanded our research unit in response to the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) leading to the COVID-19 pandemic to evaluate prevention and treatment of this infection. We currently have >25 ongoing studies, all of which have opportunities for Enrollment, Research and Collaboration:

Interested in Enrolling in a Clinical Study?

Please click here and complete the clinical study interest form.

Federally Funded Studies

Precision Interventions for Severe and/or Exacerbation Prone Asthma (Network (PrecISE, NIH funded):

This is a precision-medicine, biomarker-driven, highly novel adaptive controlled trial to establish a new treatment paradigm for severe asthma. Up to six novel therapies will initially be investigated, with new therapies considered for study as they become available. 

The trial is designed to meet our primary objectives, namely, to: (1) identify novel therapies that work in biomarker-defined subgroups of participants with severe asthma, and (2) optimize the subgroups targeted for treatment by refining the biomarker and subgroup definitions. 800 patients with severe asthma will be enrolled across 30+ sites. Our site runs the CT imaging core for this study.

CSJ117 for Patients with Severe Uncontrolled Asthma:

This is a Novartis-sponsored, 12-week, multicenter, randomized, double-blind, parallel arm, placebo-controlled study to assess the efficacy and safety of CSJ117, when added to existing asthma therapy in patients with severe uncontrolled asthma.

Severe Asthma Research Program (SARPIII, NIH funded):

This is a multi-center longitudinal study to improve the understanding of severe asthma and to develop better treatments. In SARP we seek to gain a better understanding of asthma and its endotypes, in children and adults, by defining the disease at the molecular and cellular levels in the context of the temporal phenotypic expression of the disease.

SARP IV (n=400) will extend the follow-up of the SARP III (n=750) longitudinal cohort up to 10 years with increased focus on biologic sampling and radiographic imaging to further expand our knowledge of patho-biologic mechanisms in these well characterized severe asthmatics. This iteration of SARP incorporates more comprehensive bioinformatics and systems biology as novel analytic methodology to further explore asthma heterogeneity and define sub-endophenotypes of disease. Our site runs the CT and MRI imaging core for this study.

Asthma Clinical Research Center (ACRC, ALA funded):

We are performing clinical research in adult and pediatric asthma through a national network of 40 centers. We are now enrolling in 2 new studies: and the MATCH and LHC.

In Improving Medication Adherence with Telehealthcare Medication Therapy Management to Change Health Outcomes in Adolescents and Young Adults with Asthma (MATCH) (N=300), we are studying whether having regular video calls with a pharmacist using a smart phone or computer will help adolescents and young adults with asthma to regularly take their prescribed inhaled medications and have fewer asthma symptoms.

In the Lung Health Cohort (LHC) we will form the first national cohort of adults focused on respiratory health. This cohort will include 4,000 community-dwelling adults, at the age of peak lung health (25 to 35 years old), recruited from diverse regions across the U.S. whose lung function, respiratory symptoms, lifetime residential and occupational geographic histories, health behaviors, physical activity and fitness, blood biomarkers, chest imaging, and nasal epithelial transcriptome will be measured.

The LHC is currently focused on a single cross-sectional examination of young adults to define the factors associated with impaired respiratory health in young adulthood with the long-term intention for the cohort to be a longitudinal study focused on transitions from peak lung health to impaired lung health to lung disease. We have proposed an Ancillary RO1 focused on measuring this lung growth using hyperpolarized Xenon gas MRI.

RofLumilast or Azithromycin to Prevent COPD Exacerbations:

RELIANCE (Patient-Centered Outcomes Research Institute funded). RELIANCE is a pragmatic clinical trial to compare long-term use of roflumilast vs. azithromycin in up to 3,200 patients to reduce the risk of all-cause hospitalization and reduce pre-mature deaths in individuals with chronic obstructive pulmonary disease (COPD). Enrollment is ongoing.  

Azithromycin to prevent recurrent wheezing following severe RSV bronchiolitis (APW) (NIH funded):

The goal of this project is to establish the use of the macrolide azithromycin (AZM) during severe RSV bronchiolitis as an effective intervention that substantially reduces the occurrence of post-RSV recurrent wheezing and potentially post-RSV asthma. The project will also investigate whether the beneficial effects of the interventions are related to modifications of the airway microbiome. Enrollment has been completed for this study; follow-up will be completed Feb 2021.

Pharmaceutical Studies

Sanofi Aventis (Vesige trial):

Randomized, double blind, placebo-controlled study to evaluate the effect of dupilumab on airway inflammation through assessments of lung function, mucus plugging and other lung imaging parameters in patients with asthma. Enrollment is ongoing.

Regeneron (Dupilumab IL-13 in vitro study):

This study will utilize lung epithelial cells grown in vitro under air-liquid interface conditions (ALI) to study the mechanism of action of the IL-13R blocker (Dupilumab) a biologic currently being prescribed to individuals with severe asthma. This study proposes the addition of exogenous IL‐13 will function as a differentiation signal that induces mild to moderate human bronchial epithelial cells (hBECs) to a phenotype that resembles severe asthma in tissue culture.

The addition of Dupilumab to these hBEC ALI cultures will 1) test receptor specificity by blocking the common IL‐4Rα that IL‐13 requires for downstream signal transduction, 2) elucidate IL‐4Rα‐independent IL‐13 signals that propagate cellular differentiation pathways, and importantly 3) answer whether severe asthmatic hBECs intrinsically produce IL‐13, which can be blocked by Dupilumab, that potentially signals in a self-renewal pathway resulting in increased mucin production.

AstraZeneca (Chinook):

Phase 4, Multicenter, Randomized, Double-blind, Parallel Group, Placebo controlled Study to Evaluate the Effect of Benralizumab on Structural and Lung Function Changes in Severe Eosinophilic Asthmatics. This mechanistic study will investigate the effects of airway tissue eosinophil depletion on airway wall remodeling by macroscopic, morphological changes of the bronchial wall measured by quantitative computed tomography (QCT). Enrollment is ongoing.

AstraZeneca (RESOLUTE): 

This is a multi-center phase 3 study to evaluate the efficacy and safety of Benralizumab 100 mg in patients with moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) with a history of frequent COPD exacerbations and elevated peripheral blood eosinophils.

Interested in Enrolling in a Clinical Study?

Please click here and complete the clinical study interest form.

Last modified: Jun 30, 2021