Status:
COMPLETED
Oxidative Stress in Asthma
Lead Sponsor:
Bastiaan Driehuys
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Asthma
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 wil...
Detailed Description
ABSTRACT Obesity, a major comorbidity and a potential modulator of asthma, affects nearly 40% of asthmatics in the U.S., and increases its severity. Obese asthmatics do not respond as well to convent...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Asthma Cohort INCLUSION
- 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
- Non-Asthma Cohort INCLUSION
- No history of asthma or other chronic lung diseases
- Male and female patients, 18 - 65 years old, inclusive
- Not currently smoking or using other forms of tobacco-related products (including vaping)
- Smoking history \<10 pack years and no smoking in the past 3 months
- FEV1 \> 80% of predicted and FEV1/FVC \> lower limit of normal.
- Ability to sign consent
- BMI ≥ 30 kg/m2
- Negative allergen skin test
- Additional INCLUSION Criteria for MRI
- Outpatients of either gender, age \> 18
- Willing and able to give informed consent and adhere to visit/protocol schedules. (Consent must be given before any study procedures are performed.)
- Women of childbearing potential must have a negative urine pregnancy test prior to MRI.
- EXCLUSION Criteria
- Asthma Cohort EXCLUSION:
- 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
- Non-Asthma Cohort EXCLUSION:
- 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
- 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
- Additional EXCLUSION Criteria for MRI
- Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements
- Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine, shoulder circumference \>140 cm\*.) \*This measurement is not an absolute as it can vary based on weight distribution.
Exclusion
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04512547
Start Date
April 1 2021
End Date
January 31 2025
Last Update
March 7 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Duke Asthma Allergy and Airway Center
Durham, North Carolina, United States, 27705