Abstract

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.