N/A
Completed N=117
Role of Cysteinyl Leukotrienes in the Pathogenesis of Asthma in Obesity
Source: ClinicalTrials.gov NCT01158573 ↗Enrolled (actual)
117
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcomePrimary: Plasma Leptin — 55.4; 8.9; 24.2; 46.5 ng/ml — p=<0.0001
Summary
The purpose of this study is to examine whether there are higher levels of cysteinyl leukotrienes in obese subjects than in non-obese subjects. Cysteinyl leukotrienes are pro-inflammatory substances that cause asthma by narrowing the airways of the lung. The investigators want to see if subjects with increased fat stores and therefore increased leptin, which is a fat-related protein that regulates leukotrienes, have increased levels of leukotrienes in the blood, lung and urine. The investigators would also like to determine the relationship between cysteinyl leukotrienes and exhaled nitric oxide levels in asthmatics with and without obesity. Nitric oxide is anti-inflammatory and suppresses leukotriene synthesis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Leptin |
55.4; 8.9; 24.2; 46.5 | <0.0001 sig |
| PRIMARY Exhaled Nitric Oxide (FeNO) |
17.8; 20.7; 29.5; 19.9 | 0.002 sig |
| PRIMARY Urine Cysteinyl Leukotriene Per Creatinine |
7.21; 6.35; 6.31; 6.67 | 0.725 |
| PRIMARY Ratio U Cys-LT/FeNO |
0.5; 0.42; 0.3; 0.44 | 0.16 |
Eligibility Criteria
Inclusion Criteria
- 18-65 yr old adults with asthma, non-smoking for at least one year
- Healthy non-smoking adults, aged 18-65 without asthma
- Heavy subjects with BMI > 30 kg/m2
- Subjects with normal weight (BMI between 20-25 kg/m2)
- Subject not taking anti-leukotriene therapy (Singulair, Accolate, Zyflo)
Exclusion Criteria
- No chronic oral steroid use
- No recent history of infection
- No recent history of flare of lung disease
Data sourced from ClinicalTrials.gov (NCT01158573). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.