Oxidative Stress in Asthma

NCT04512547 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: Pro00104900R01HL153641-01
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

40% of all asthma patients in the US are obese. Obese asthmatics have more severe disease than lean asthmatics and do not respond as well to conventional anti-inflammatory therapies. This proposal 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 preclinical models of obese asthma.

Conditions

Asthma; Obesity

Keywords

Asthma; MRI; Obesity

Outcome Measures

Primary Outcomes (2)

• Percentage of Neutrophils in Peripheral Blood

  Up to 6 weeks

• Percentage of Eosinophils in Peripheral Blood

  Up to 6 weeks

Other Outcomes (5)

• Percent Trichrome or Elastic or Fiber Staining Between Fixed and Reversible Airway Segments

  Up to 6 weeks

• Percent Change in Intracellular ROS Production by Airway Fibroblasts as Measured by Flow Cytometry

  Baseline, visit 1 (one week +/- 7 day), visit 2 (one week +/- 7 day), visit 3 (one week +/- 7 day)

• Leptin Stimulated Human Airway Fibroblast Invasiveness as Measured by Mean Numbers of Invading Fibroblasts

  Up to 6 weeks

Study Arms (2)

Obese Asthmatics

EXPERIMENTAL

Obese patients that come to Duke that have been diagnosed with Asthma will be approached.

Drug: Hyperpolarized 129XeMRI

Obese Non-Asthmatics

ACTIVE COMPARATOR

The obese non-asthmatics will be collected from an IRB pre-approved Healthy Volunteer Data Repository.

Drug: Hyperpolarized 129XeMRI

Interventions

Hyperpolarized 129XeMRI DRUG

Images obtained using 129XeMRI will be obtained on both obese asthmatic and non-asthmatics

Obese Asthmatics; Obese Non-Asthmatics

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adequate completion of informed consent process with written documentation
• Male and female patients, 18 - 65 years old, inclusive
• Physician diagnosis of asthma for \> 1 year
• Able to perform reproducible spirometry according to ATS criteria
• Post-bronchodilator FEV1 ≥ 60% of predicted at Visit 0
• All racial/ethnic backgrounds may participate
• BMI ≥ 30 kg/m2
• Regular treatment with ICS or ICS/LABA and/or LAMA combination medication for at least 3 months; on a stable dose for the 4 weeks prior to Visit 0
• Smoking history \<10 pack years and no smoking in the last 3 months
• Late onset asthma: Age of asthma onset (diagnosis) ≥12 years;
• FeNO \< 25 ppb at Visit 0
• Negative allergen skin test
• Early onset asthma: Age of asthma onset (diagnosis) \<12 years
• FeNO ≥ 25 ppb at Visit 0
• Positive allergen skin test

You may not qualify if:

• Respiratory tract infection within the 4 weeks prior to Visit 0
• Oral or systemic corticosteroid burst (for any indication) within the 4 weeks prior to Visit 0. One-time doses, such as intra-articular injections into a shoulder or knee joint, require a 4- week washout prior to Visit 0
• Asthma-related ER visit within the previous 4 weeks of Visit 0
• History of ICU admission/intubation due to asthma in the past 1 year
• Three or more asthma exacerbations requiring treatment with systemic corticosteroids in the past year consistent with severe asthma
• Asthma exacerbation requiring systemic corticosteroids within the 4 weeks prior to Visit 0
• Significant concomitant medical illness, including (but not limited to) heart disease, cancer, uncontrolled diabetes, other chronic lung diseases
• Chronic renal failure (creatinine \> 2.0) at Visit 0
• Positive urine pregnancy test at Visit 0 or at any time during the study
• Untreated sleep apnea
• Participation in an intervention study (including, bronchoscopy) or use of investigative drugs within the past 30 days or plans to enroll in such a trial during the study
• Unable or unlikely to complete study assessments in the opinion of the Investigator
• Study intervention poses undue risk to patient in the opinion of the Investigator
• History of bronchial thermoplasty
• Respiratory tract infection within the 4 weeks prior to Visit 0 Oral or systemic corticosteroid burst (for any indication) within the 4 weeks prior to Visit 0. One-time doses, such as intra-articular injections into a shoulder or knee joint, require a 4-week washout prior to Visit 0

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Bastiaan Driehuys: lead

Study Sites (1)

Duke Asthma Allergy and Airway Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Asthma; Obesity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Loretta Que
• Organization: Duke University Medical Center

loretta.que@duke.edu

(919) 681-8551

Study Officials

• Loretta Que, MD

  Duke

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: August 13, 2020
• Study Start: April 1, 2021
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: March 23, 2026
• Results First Posted: March 23, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)