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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01HL132550-03 | U.S. NIH Grant/Contract | View source | |
| 1R61HL157069-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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. This impacts the lung, increasing the severity of asthma and its exacerbations. This research will evaluate how a synthetic nitro-fatty acid (CXA-10, 10-nitro-octadec-9-enoic acid) suppresses the systemic and airway inflammation that contributes to the obese asthmatic phenotype. Current data support the pleiotropic signaling actions of CXA-10 to induce adaptive signaling actions that beneficially modulate adipokine and cytokine expression and inhibit systemic and pulmonary inflammation. The investigators hypothesize that CXA-10 induced signaling responses will alleviate obesity-related airway hyperreactivity in obese adult asthmatics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CXA-10 | Experimental | Administered orally, continuously, and daily for at least 6 weeks. Dispensed at Visit 1. Washout period of at least 4 weeks and then enter crossover phase of an additional 6 weeks. Drug will be dispensed at Visit 4. |
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| Matching Placebo | Placebo Comparator | Administered orally, daily, and continuously for at least 6 weeks. Dispensed at Visit 1. Washout period of at least 4 weeks and then enter crossover phase of an additional 6 weeks. Placebo will be dispensed at Visit 4. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CXA-10 | Drug | 6 weeks of treatment with 150 mg/day of orally administered CXA-10 |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Methacholine challenge dose per spirometry | To determine CXA-10 efficacy, reduction of bronchial hyperresponsiveness determined by performing spirometry to see if there's a change in methacholine dose | Through study completion, up to 18 weeks |
| Changes in pre-bronchodilator FEV1 per spirometry | To determine the efficacy of CXA-10 by improving FEV1 | Through study completion, up to 18 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Asthma Research | Contact | 1 (844) 365-0852 | asthmaresearch@ucdenver.edu |
| Name | Affiliation | Role |
|---|---|---|
| Fernando Holguin, MD, MPH | University of Colorado Denver- Anschutz Medical Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Recruiting | Aurora | Colorado | 80045 | United States |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C000656258 | CXA-10 |
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| Matching Placebo | Drug | 6 weeks of treatment with orally administered matching placebo (to 150 mg/day of CXA-10) |
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |