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New treatment option for Asthma
Official title Anti Inflammatory Lipid Mediators in Asthma Lipid Anti-Inflammtory Mediators in Asthma
ClinicalTrials.gov ID: NCT03762395
What this study is testing
What is CXA-10?
CXA-10 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for asthma.
Also referred to as 10-nitro-9(E)-octadec-9-enoic acid.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The main purpose of this Phase 2 double blind, placebo controlled crossover clinical study is to demonstrate the efficacy and safety of CXA-10 in obese adult asthmatics. Obesity induces a chronic systemic inflammatory state characterized by impaired adipokine signaling, pro-inflammatory cytokine responses, inflammatory cell activation and enhanced generation of oxidative inflammatory mediators.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Adequate completion of informed consent process with written documentation. Male and female patients, 18 to 65 years old. Female people should be...
- BMI \>/= 30
- Diagnosis of asthma: based on previous physician diagnosis for \> 6 months, and baseline pre-bronchodilator (BD) FEV1 between 50 and 95% predicted...
- Regular treatment with inhaled corticosteroids (ICS) (up to 1000 mcg/day fluticasone/equivalent), long acting beta agonists (LABA), and/or...
You likely can't join 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 6 weeks
- 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
- Current smoking or have former smokers that quit within the previous 1 year, or 10 pack years
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.