Oxidative Stress in Asthma

Korábbi kezelés

• 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
• 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
• 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
• 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
• 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

Más betegség

• History of ICU admission/intubation due to asthma in the past 1 year
• History of bronchial thermoplasty
  • Non-Asthma Cohort EXCLUSION:
• 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.

Laborértékek

• Chronic renal failure (creatinine > 2.0) at Visit 0
• Chronic renal failure (creatinine > 2.0) at Visit 0

Egyéb

• Asthma Cohort EXCLUSION:
• Positive urine pregnancy test at Visit 0 or at any time during the study
• Untreated sleep apnea
• 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
• Positive urine pregnancy test at Visit 0 or at any time during the study
• Untreated sleep apnea
• 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

• 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.