Anti-Inflammatory Lipid Mediators in Asthma

Exclusion Criteria

• •1. Respiratory tract infection within the last 4 weeks
• •2. Oral or systemic corticosteroid burst within the last 4 weeks
• •3. Asthma-related hospitalization within the last 2 months
• •4. Three or more asthma exacerbations requiring treatment with systemic corticosteroids in the past year consistent with severe asthma
• •5. Asthma-related ER visit within the previous 4 weeks
• •6. Significant or uncontrolled concomitant medical illness including (but not limited to) heart disease, cancer, or diabetes at the discretion of the investigator
• •7. History of ICU admission/intubation due to asthma in the past year
• •8. Current statins use, patients may stop and re-enroll after 4 weeks of stopping statins
• •9. Positive pregnancy test at screening and at pre-dose
• •10. Women who are breastfeeding
• •11. Women of childbearing potential who are unwilling to use an acceptable method of birth control.
• •12. Intolerance or hypersensitivity to the CXA-10 or it's excipients
• •13. Treatment with any investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the beginning of dosing (this includes investigational formulations of marketed products, inhaled and topical drugs
• •14. Unable or unlikely to complete study assessments or the study intervention (i.e. bronchoscopy) poses undue risk to patient in the opinion of the Investigator;
• •15. Any kind of oral nitrates such as nitroglycerin
• •16. Any clinical history of cardiovascular events, arrhythmias, fainting, palpitations within the previous 3 years
• •17. Personal or family history of congenital prolonged QT syndromes or sudden unexpected death due to a cardiac reason
• •18. History of any primary malignancy, including a history of melanoma or suspicious undiagnosed skin lesions, with the exception of basal cell or squamous cell carcinomas of the skin
• •19. Cervical carcinoma in situ or other malignancies curatively treated and with no evidence of disease for at least 5 years
• •20. History of alcohol or drug abuse in the 6 month period prior to enrollment
• •21. Treatment with vitamins, herbal and dietary supplements within 7 days or 5 - ½ lives whichever is longer prior to dosing until the final study visit, whichever is longer prior to dosing until the final study visit. (may rescreen after a washout)
• •22. Resting heart rate ≥100 BPM after 5 minutes rest at screening
• •23. Subjects with any other clinically relevant ECG parameter abnormality (e.g., PR interval, QRS deviation) or any clinically significant ECG abnormality will be excluded from the study. Any clinically significant abnormalities on 12-lead ECG at screening including, but not limited to any of the following:
• •* PR interval \>200 msec or \<120 msec
• •* Non-specific intra-ventricular conduction delay (IVCD) with QRS duration ≥110 msec and where the morphology does NOT meet criteria for left (LBBB) or right bundle branch block (RBBB)
• •* Incomplete RBBB as defined by QRS duration ≥110 msec but \<120 msec with RBBB pattern
• •* Complete RBBB and LBBB
• •* Evidence of second- or third- degree AV block
• •* Pathological Q-waves (Q-wave wider than 0.04 sec or depth greater than 0.4-0.5 mV)
• •* Evidence of ventricular pre-excitation
• •* Evidence of left axis deviation (left axis deviation is -30 to -90 degrees) but not normal leftward axis, ST-T wave abnormalities, LBBB and/or RBBB
• •24. Any clinically significant murmurs evident on auscultation of the heart (including evidence of mitral valve prolapse)
• •25. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>3.0X upper limit of normal (ULN), gamma-glutamyl transferase (GGT) \>3X ULN, and total bilirubin \>2X ULN. If all liver function tests (LFTs) are within normal limits (WNL) and total bilirubin is elevated, examination of direct and indirect bilirubin may be conducted. Subjects with indirect total bilirubin up to 3X ULN are presumed to have Gilbert's syndrome and may be enrolled if all other LFTs are WNL
• •26. Any other condition and/or situation that causes the Investigator to deem a subject unsuitable for the study (e.g., due to expected study medication non-compliance, inability to medically tolerate the study procedures, or a subject's unwillingness to comply with study-related procedures)
• •27. Diagnosis of HIV
• •28. Patients with multiple sclerosis on dimethyl fumarate (tecfidera)
• •29. Patients with asthma on biological therapy (i.e. mepolizumab, omalizumab)