Asthma Clinical Trials

Clinical research is currently underway in our division to examine the mechanisms of asthma and potential treatments and therapies to combat this disease. Our researchers conduct research in conjunction with the Duke Asthma, Allergy, and Airway Center.

Current Clinical Trials

The following clinical research initiatives are being conducted in our division:

A Longitudinal Prospective Observational Study of the Characteristics, Treatment Patterns and Health Outcomes of Individuals with Severe Asthma in the United States. This is an asthma registry. Patients can participate in other studies while enrolled in the Chronicle Study. 

Principal Investigator: Loretta Que, MD
Status: Recruiting
IRB Number: Pro00092249
Clinical Trials.gov #: NCT03373045
Study Team Contact: Jessica Shier – jessica.shier@duke.edu

 

The purpose of this study is to understand how hormones involved in obesity and insulin regulation interact with disease processes in allergic asthma. We are interested in evaluating cellular functions that contribute to airway fibrosis in early-onset allergic asthma. Non-diabetic, obese asthma patients with onset of disease before age 12 can enroll. 

Principal Investigator: Jennifer Ingram, PhD and Loretta Que, MD
Status: Closed to Accrual
IRB Number: Pro00077482
Clinical Trials.gov #: NCT03115632
Study Team Contact: Shelby Martindale - Shelby.martindale@duke.edu

 

Amino acids are most commonly known as building blocks of proteins, the same as the proteins found in food. Asymmetric dimethyl arginine or ADMA is derived from the amino acid, L-arginine. The balance of L-arginine to ADMA may be important to the lung health of patients with asthma. The purpose of this 2-week study is to determine whether supplementation with L-citrulline, a naturally occurring amino acid which is a precursor of L-arginine, changes exhaled nitric oxide levels and ADMA in the blood of overweight patients with asthma. 

Principal Investigator: Loretta Que, MD
Status: Recruiting
IRB Number: Pro00104357
Clinical Trials.gov #: NCT03885245
Study Team Contact: Kaitlin Mae Foy - kaitlin.jones@duke.edu

It is hypothesized that in airway epithelial cells, unique transcriptomic and proteomic expression patterns distinguish allergic and non-allergic patients with asthma and obesity and drive significant differential responses to dupliumab. This study will investigate the role of dupliumab in the treatment of asthma with comorbid obesity. This is a pre-clinical research study.

Principal Investigator: Jennifer Ingram, PhD and Loretta Que, MD
Status: Recruiting
IRB Number: Pro00107990
Clinical Trials.gov #: NCT05478824
Study Team Contact: Jessica Shier – Jessica.shier@duke.edu

 

Obese asthmatics have more severe disease than lean asthmatics and do not respond as well to conventional anti-inflammatory therapies. This study will utilize 3D functional imaging with 129XeMRI and single cell RNA sequencing to study mechanisms driving regional airway remodeling and fibrosis in obese asthma subjects and in pre-clinical models of obese asthma.

Principal Investigator: Loretta Que, MD
Status: Recruiting
IRB Number: Pro00104900
Clinical Trials.gov #: NCT04512547
Study Team Contact: Shelby Martindale – Shelby.martindale@duke.edu

The purpose of this study is to determine If an antioxidant pill called mitoquinol (mitoQ) might be helpful to control asthma. This is a 14-week, randomized, double-masked clinical trial in patients with poorly controlled asthma; half of the patients in the study will take the antioxidant pill, and half will take a placebo pill (a pill that looks like the antioxidant pill).

Principal Investigator: Loretta Que, MD
Status: Recruiting
IRB Number: Pro00102278 
Clinical Trials.gov #: NCT04026711
Study Team Contact: Katie Williford - katherine.williford@duke.edu

 

This study is a randomized, 12-month study targeted to an at-risk population of Adolescents and Young Adults with uncontrolled asthma who have poor adherence with prescribed Inhaled corticosteroid (ICS) therapy.

Principal Investigator: Loretta Que, MD
Status: Recruiting
IRB Number: Pro00101757
Clinical Trials.gov #: NCT03978936
Study Team Contact: Kaitlin Mae Foy - kaitlin.jones@duke.edu

This study is a longitudinal, cohort study that will enroll young adults between the ages of 25-35 who do not have severe lung disease. The objective of the study 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.

Principal Investigator: Loretta Que, MD
Status: Recruiting
IRB Number: Pro00105522
Clinical Trials.gov #: NCT04543461
Study Team Contact: Kaitlin Mae Foy - kaitlin.jones@duke.edu

Historically Relevant Clinical Trials

Select a trial to read the full description on the clinicaltrials.gov Web site.

The purpose of this study is to identify the genes in important airway cells that are specifically expressed following inhalation of house dust mite allergen among study subjects with either allergic asthma or healthy normal phenotypes. This approach is designed to identify novel genes associated with both asthma pathogenesis (differentially expressed in the exposure-response study) and asthma susceptibility (genetically associated with asthma in a linkage/association study) for drug targets.

Principal Investigator: John Sundy, MD, PhD
ClinicalTrials.gov #: NCT00671593

The goals of the research are designed to accomplish genetic association studies of candidate genes in healthy normal individuals exposed to 0.2 ppm for 2.25 hours with intermittent exercise in order to search for associations between defined genotypes/haplotypes and three specific in vivo respiratory endpoints: a) change in FEV1 immediately after ozone exposure; b) change nonspecific bronchial reactivity as reflected in the change in methacholine PC20 FEV1 24 hours after ozone exposure; and c) change in lung epithelial integrity as reflected in the Clearance Halftime of technetium 24 hours after ozone exposure.

Principal Investigator: W Michael Foster, PhD
ClinicalTrials.gov #: NCT00574158

The overall goal of this project is to identify genes that are involved in the development of airflow obstruction and airway inflammation in asthmatics, and to determine whether polymorphisms in these differentially expressed genes predispose individuals to develop asthma.

Principal Investigator: John Sundy, MD, PhD
ClinicalTrials.gov #: NCT00671892

Enroll in an Asthma or Allergy Clinical Trial

Asthma and allergy trials: Our division has several investigators examining remodeling, host immune defense mechanisms, gene-environment interactions, and pharmacologic therapies. 

Visit DukeMedicine.org for a list of current clinical trials.