Interested in Enrolling in a Clinical Study?
Complete the clinical study interest form and you will be contacted within 3 business days.
Clinical Study Interest Form
AATRU Clinical Trials
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?
complete the clinical study interest form
Information on current studies may be found by choosing a title below:
Federally Funded Studies
RELIANCE
A multi-center, randomized, 48-month, parallel- group, non-inferiority, phase III study to compare the effectiveness of 500 mcg QD or alternate regimen of roflumilast (Daliresp) therapy versus 250 mg QD, 500 mg QD three times per week, or alternate regimen of azithromycin therapy to prevent COPD exacerbations.
- Enrollment Status: Closed to Enrollment
- Study Type: Interventional (Clinical Trial)
- Sponsors: Johns Hopkins University, Patient-Centered Outcomes Research Institute
- PI: Mario Castro, MD, MPH
Lung Health Cohort (LHC)
The ALA-LHC is a longitudinal, multi-center cohort study that will enroll approximately 4,000 young adults between the ages of 25-35 who do not have severe lung disease. The overarching objective of the ALA-LHC is to establish a national cohort of young adults for the purpose of defining lung health and developing targets to intercept chronic lung disease at its earliest stages.
- Enrollment Status: Recruiting
- Study Type: Observational
- Sponsors: Johns Hopkins University, National Heart, Lung, and Blood Institute (NHLBI), American Lung Association, Stanford University
- PI: Mario Castro, MD, MPH
PreCISE
PrecISE is an NHLBI-sponsored network established to conduct a phase 2 proof-of-concept study to test interventions in biomarker-defined subgroups of patients with severe asthma.
- Enrollment Status: Closed to Enrollment
- Study Type: Interventional (Clinical Trial)
- Sponsors: University of North Carolina-Chapel Hill & National Heart, Lung, and Blood Institute (NHLBI)
- PI: Mario Castro, MD, MPH
SARP-4
The mission of the SARP is to improve the understanding of severe asthma through integrated study of its clinical and biological features and to evaluate their changes over time. The ultimate goal of these efforts is to promote better treatments for severe asthma.
- Enrollment Status: Closed to Enrollment
- Study Type: Observational
- Sponsors: Milton S. Hershey Medical Center & National Heart, Lung, and Blood Institute (NHLBI)
- PI: Mario Castro, MD, MPH
Pharmaceutical Studies
Chinook
A 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.
- Enrollment Status: Closed to Enrollment
- Study Type: Interventional (Clinical Trial)
- Sponsor: AstraZeneca AB
- PI: Mario Castro, MD, MPH
Oberon
A Phase III, Multicentre, Randomized, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Two Dose Regimens of MEDI3506 in Participants with Symptomatic Chronic Obstructive Pulmonary Disease (COPD) with a History of COPD Exacerbations.
- Enrollment Status: Closed to Enrollment
- Study Type: Interventional (Clinical Trial)
- Sponsor: AstraZeneca AB
- PI: Mario Castro, MD, MPH
Resolute
A Multicenter, Randomized, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled 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.
- Enrollment Status: Closed to Enrollment
- Study Type: Interventional (Clinical Trial)
- Sponsor: AstraZeneca
- PI: Mario Castro, MD, MPH
Aerify-3
Mechanistic study of the effect of itepekimab on airway inflammation in patients with COPD.
- Enrollment Status: Recruiting
- Study Type: Interventional (Clinical Trial)
- Sponsor: Sanofi
- PI: Mario Castro, MD, MPH
Flair
A Randomized, Double-Blind, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate Fixed-Dose Combination on Severe Asthma Exacerbations in Patients With Asthma
- Enrollment Status: Closed to Enrollment
- Study Type: Interventional (Clinical Trial)
- Sponsor: Teva Branded Pharmaceutical Products R&D Inc.
- PI: Mario Castro, MD, MPH
AIM4
The AIM4: Next Step study is a multicenter, multinational, randomized, double-blind, active-controlled, parallel group study assessing the effect of dupilumab added to medium dose ICS/LABA in comparison with escalation to high dose ICS/LABA in participants who are uncontrolled on medium dose ICS/LABA
- Enrollment Status: Closed to Enrollment
- Study Type: Interventional (Clinical Trial)
- Sponsor: Regeneron
- PI: Mario Castro, MD, MPH
Airlympus
A randomized, Phase 2, double-blind, placebo-controlled, parallel-group, 2-arm study to investigate the efficacy, safety, and tolerability of subcutaneous lunsekimig (SAR443765) in adult participants with high-risk asthma who are not currently eligible for biologic treatment.
- Enrollment Status: Closed to Enrollment
- Study Type: Interventional (Clinical Trial)
- Sponsor: Sanofi
- PI: Mario Castro, MD, MPH
Imagine
A phase 3b open label, single arm study to assess the effect of depemokimab on airway structure and function in asthma with Type 2 inflammation characterized by an eosinophilic phenotype utilizing quantitative high-resolution CT and bronchoscopic airway sampling in a sub-study.
- Enrollment Status: Open to Enrollment
- Study Type: Interventional (Clinical Trial)
- Sponsor: GlaxoSmithKline Research & Development Limited
- PI: Mario Castro, MD, MPH
Pfizer_C4531029
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Investigate the Efficacy and Safety of PF-07275315 in Adult Participants with Inadequately Controlled Moderate-to-Severe Asthma.
- Enrollment Status: Open to Enrollment
- Study Type: Interventional (Clinical Trial)
- Sponsor: Pfizer
- PI: Mario Castro, MD, MPH
Seabreeze STAT Asthma
A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Rademikibart as an Add-on Treatment for Acute Exacerbation in Adult and Adolescent Participants with Asthma and Type 2 Inflammation.
- Enrollment Status: Open to Enrollment
- Study Type: Interventional (Clinical Trial)
- Sponsor: Connect Biopharma
- PI: Mario Castro, MD, MPH
Celldex_CDX622-02
An Open-Label, Single-Dose Study to Assess the Safety, Pharmacodynamics, and Pharmacokinetics of CDX-622 in Adults With Mild to Moderate Asthma.
- Enrollment Status: Open to Enrollment
- Study Type: Interventional (Clinical Trial)
- Sponsor: Celldex Theraputics
- PI: Mario Castro, MD, MPH
RoCCPORT
A Prospective Cohort Study of Patients with Refractory or Unexplained Chronic Cough measuring Cough Variability and Burden on Patients’ Lives.
- Enrollment Status: Open to Enrollment
- Study Type: Interventional (Clinical Trial)
- Sponsor: GlaxoSmithKline
- PI: Mario Castro, MD, MPH
ASPIRE
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Taplucainium Inhalation Powder (NOC-110) in Adults with Refractory or Unexplained Chronic Cough.
- Enrollment Status: Closed to Enrollment
- Study Type: Interventional (Clinical Trial)
- Sponsor: Nocion Therapeutics, Inc.
- PI: Mario Castro, MD, MPH
PERSEPHONE
A Phase 2b/Phase 3, randomized, double-blind, placebo -controlled, multicenter study, to investigate the efficacy and safety of lunsekimig in adult participants with inadequately controlled chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype.
- Enrollment Status: Open to Enrollment
- Study Type: Interventional (Clinical Trial)
- Sponsor: Sanofi
- PI: Mario Castro, MD, MPH
Journey
A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of Tezepelumab in Adult Participants with Moderate to Very Severe Chronic Obstructive Pulmonary Disease.
- Enrollment Status: Open to Enrollment
- Study Type: Interventional (Clinical Trial)
- Sponsor: AstraZeneca AB
- PI: Mario Castro, MD, MPH
Seabreeze STAT COPD
A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Rademikibart as an Add-on Treatment for Acute Exacerbation in Participants With Chronic Obstructive Pulmonary Disease and Type 2 Inflammation.
- Enrollment Status: Open to Enrollment
- Study Type: Interventional (Clinical Trial)
- Sponsor: AstraZeneca AB
- PI: Mario Castro, MD, MPH
COPD-OMA
Multicenter phase II placebo-controlled, masked, randomized superiority clinical trial of omalizumab vs placebo in individuals with COPD having sensitization and exposure to indoor allergens.
- Enrollment Status: Open to Enrollment
- Study Type: Interventional (Clinical Trial)
- Sponsor: ACRC
- PI: Mario Castro, MD, MPH
Apogee_APG777-105
A Phase 1b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of APG777 in Adults With Mild-to-Moderate Asthma.
- Enrollment Status: Closed to Enrollment
- Study Type: Interventional (Clinical Trial)
- Sponsor: Apogee Therapeutics, Inc
- PI: Mario Castro, MD, MPH
PROSPERO
A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Extension Study to Evaluate the Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease (COPD) With a History of Exacerbations.
- Enrollment Status: Closed to Enrollment
- Study Type: Interventional (Clinical Trial)
- Sponsor: AstraZeneca AB
- PI: Mario Castro, MD, MPH
Levante
A 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.
- Enrollment Status: Closed to Enrollment
- Study Type: Interventional (Clinical Trial)
- Sponsor: AstraZeneca AB
- PI: Mario Castro, MD, MPH
Investigator Initiated Studies
AATRU Bronchoscopy Biobank
- Enrollment Status: Recruiting
- Study Type: Observational
- PI: Mario Castro, MD, MPH
AATRU Biobank
- Enrollment Status: Recruiting
- Study Type: Observational
- PI: Mario Castro, MD, MPH
Completed Studies
- ABPA Asthma
- ALA ABBS
- ALA ABBS
- ALA LEEP
- APW-RSV II
- Asthma EV
- CoVPN D8110C00001
- MATCH
- Novartis CSJ117A12201C
- PCORnet HERO HCQ
- Regeneron R668-AS-1903
- Reliance (Phase 1)
- RheSolve
- Sanofi_DRI17509
- Shinogi Cough
- TEVA TV48574-AS-20031
- Theravance TD-4208-0192
- Vestige LPS15834
