Anti-Inflammatory Lipid Mediators in Asthma

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

The purpose of this study is to demonstrate the efficacy and safety of 10-nitro-9(E)-octadec-9-enoic acid (CXA-10) in obese adult asthmatics. The study's hypothesis is that 150 mg/day of CXA-10 for 12 weeks will alleviate obesity-related airway hyper-reactivity in obese adult asthmatics.

Key facts

Study ID

NCT03680976

Run by

Sally E. Wenzel MD

People needed

0

Expected to finish

2021-04-01

Last updated by the study team

2018-09-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adequate completion of informed consent process with written documentation. Male and female patients, 18 to 65 yrs old female subjects should be either post-menopausal, surgically sterile, or women of child-bearing potential (WOCP) with a negative pregnancy test prior to entering the study and who agree to use an acceptable method of contraception, for the duration of the study.
• Diagnosis of asthma: based on previous physician diagnosis for > 6 months, and either baseline pre-bronchodilator (BD) FEV1 between 50 and 90% predicted with a 12% or greater bronchodilator response to 4 puffs of albuterol or PC20 methacholine (16 mg) if no BD response (<12% change), within 2 years of Visit 0. If no historical reversibility or historical PC20, and the participant does not reverse 12% at V0, the participant can return for V0a to meet this eligibility criteria.
• Daily treatment with inhaled corticosteroids and long acting beta agonists (ICS/LABA) combination medication for at least 3 months; on a stable dose for the 4 weeks prior to Visit 0
• Asthma control questionnaire ACQ > 1.5 \& ≤ 3
• Smoking history <10 pack years and no smoking in the last year
• Body Mass Index (BMI) ≥ 30 kg/m2
• Hemoglobin A1c (HbA1c) <8%
• Average systolic blood pressure <160 or diastolic < 100 mmHg (average of three measurements))
• Resting HR ≥45 beats per minute (BPM) after 5 minute rest at screening
• QTcF interval (Fredericia's correction factor) must be ≤430 msec at screening and pre-dose for males and ≤450 msec for females.
• For randomization: No exacerbations or treatment failures during the run in. Patients, who exacerbate or experience treatment failure during the run-in, may re-enroll 4 weeks after the exacerbation has resolved (completed course of systemic corticosteroids).

You may not qualify if…

• Respiratory tract infection within the last 4 weeks
• Oral or systemic corticosteroid burst within the last 4 weeks
• Asthma-related hospitalization within the last 2 months
• Three or more asthma exacerbations requiring treatment with systemic corticosteroids in the past year consistent with severe asthma
• Asthma-related ER visit within the previous 4 weeks
• Significant or uncontrolled concomitant medical illness including (but not limited to) heart disease, cancer, or diabetes at the discretion of the investigator
• History of ICU admission/intubation due to asthma in the past year
• Current statins use, patients may stop and re-enroll after 4 weeks of stopping statins
• Positive pregnancy test at screening and at pre-dose
• Women who are breastfeeding
• Women of childbearing potential who are unwilling to use an acceptable method of birth control.
• Intolerance or hypersensitivity to the CXA-10 or it's excipients
• 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
• 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;
• Any kind of oral nitrates such as nitroglycerin
• Any clinical history of cardiovascular events, arrhythmias, fainting, palpitations within the previous 3 years
• Personal or family history of congenital prolonged QT syndromes or sudden unexpected death due to a cardiac reason
• 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
• Cervical carcinoma in situ or other malignancies curatively treated and with no evidence of disease for at least 5 years
• History of alcohol or drug abuse in the 6 month period prior to enrollment
• 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)
• Resting heart rate ≥100 BPM after 5 minutes rest at screening
• 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)

Where it is running

• The University of Pittsburgh Asthma Institute at UPMC — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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