Efficacy of Seratrodast, a Thromboxane A2 Receptor Inhibitor in a Double Blind Comparative Clinical Trial with Monteluklast.

Aims: To assess the comparative efficacy, safety and tolerability of seratrodast versus montelukast in controlling mild to moderate asthma in adult patients. Study Design: Randomized, comparative, double blind, double dummy, multi-center, parallel group, non inferiority study. Methods: Patients (n=205) with mild to moderate asthma continuing on the lowest dose of inhaled corticosteroid were recruited from 3 different centers across India. Patients were randomly assigned to receive either seratrodast 80 mg (n=103) or montelukast 10 mg (n=102) once daily for 28 days. The treatments were compared for improvement from the baseline values, as per the changes in asthma symptom score (wheezing, shortness of breath, expectoration, cough and chest tightness), lung function parameters (PEF, FVC and FEV1), sputum and mucociliary parameters [fucose, eosinophil cationic protein (ECP) and albumin]. Results: Seratrodast and montelukast showed improvement in the clinical parameters of asthma as well as in the lung function tests and sputum parameters from baseline. Both the treatments significantly increased mean values of PEF, FVC and FEV1 from the baseline after a 4 week treatment but seratrodast produced significantly greater improvement in PEF (0.416 L/s, P=.01). Moreover, there was significantly more reduction in expectoration score (P=.01), sputum concentrations of ECP (P<.001) and albumin (P<.001) in seratrodast group, signifying improvement in asthma condition. The two treatment groups had similar tolerability profiles. Mild increase in hepatic enzymes was seen in both the groups with no clinical significance. No serious adverse events were observed during the study. Conclusions: Seratrodast, a Thromboxane A2 receptor antagonist, was found to be better in the improvement of PEF, reduction in expectoration, ECP and albumin levels as compared to montelukast. Seratrodast can be recommended as a controller medication in mild to moderate asthma.

Comparative study of Eosinophil and Eosinophil Cationic Protein (ECP) of Tears and Sera in Children with Allergic Conjunctivitis

The objective of this study is to measure eosinophil count and Eosinophil Cationic Protein (ECP) levels of tears and sera in patients with acute allergic conjunctivitis and normal subjects and to assess the correlation of this mediator with allergic conjuctivitis and the clinical usefulness. Seventeen subjects were selected on the basis of clinical manifestation, history, skin prick test, total IgE. Serum IgE and eosinophil count were increased in 10patients, and eosinophilia in conjunctival epithelium were present in 11subjects. ECP in tears were increased in patients significantly (12.0+/-8.0 vs 3.9+/-3.8ng/ml,p=0.01), but not in serum (52.5+/-43.1 vs 28.3+/-25.9ng/ml). There was significant relationship beween serum and tear eosinophil count(p=0.004,r=0.66). But there was no significant correlation between eosinophil count and ECP in serum (p>0.05m r=0.19), and no significant correlation between eosinophil count of conjectival epithelium and tears ECP (p=0.043, r=0.05). In conclusion, ECP in tears may be very important role in allergic conjunctivitis and is more reliable indicatior of diagnosis clinically rather than eosinophil count in tear and conjunctival epithelium.

Eosinophil Cationic Protein in HSP and in IgA Nephropathy / 대한신장학회잡지

Interleukin-5 (IL-5), which is known to be an activator of human eosinophil, increases in IgA nephropathy. In order to find out the relationship between activated eosinophil function and the pathogenesis of Henoch-Sch nlein purpura (HSP) and IgA nephropathy, serum esosinophil cationic protein (ECP) was analyzed using a monoclonal antibody Besides, the soluble IL-2 receptor (sIL-2R) was analyzed to clarify if there was a positive correlation between T cells and activated eosinophils. As anticipated, the levels of ECP, in detail, were significantly higher among HSP patients with a mean of 9.7+/-1.8microgram/L than in a control group with a mean of 4.6+/-0.7microgram/L. The HSP patients were also classified as one group with normal urine and another group with abnormal urine. The latter showed higher levels of ECP than the former. On the other hand, the levels of ECP were higher in IgA nephropathy patients than in the control group; however, there was no significance in statistics. The sIL-2R levels were higher in HSP patients than those in serums of IgA nephropathy patients and the control group. Thus, this study came to a conclusion that the activated eosinophil might be one of the pathogeneses in HSP but not in IgA nephropathy.