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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.
RESUMO
En el manejo del episodio agudo de asma, dos aspectos son básicos: la valoración de la gravedad del cuadro y los diferentes escalones en el tratamiento del mismo. La clasificación de la gravedad se basa en parámetros clínicos y funcionales. Los síntomas del asma se asocian no sólo con la broncoconstricción, sino también con inflamación de la vía aérea. Los β2-Agonistas inhalados tienen un rápido inicio de acción broncodilatadora mediada principalmente por un efecto relajante sobre el músculo liso respiratorio. Los corticosteroides también tienen efectos clínicos rápidos que pueden suprimir la inflamación de las vías inferiores. La decisión de hospitalizar se debe basar en el criterio clínico del médico (severidad de la crisis y respuesta a la terapia inicial), así como en factores sociales y comportamentales de cada paciente.
Two aspects are basic in the management of an acute episode of asthma: the assessment of its severity and the different steps that should be taken in its treatment. Classification of severity is based on clinical and functional parameters. Asthma symptoms are associated not only with bronchoconstriction but also with inflammation of the respiratory airway. Inhaled β2-agonists have a rapid onset of bronchodilator action that is mainly mediated by a relaxing effect on the airway smooth muscle. Corticosteroids also have rapid clinical effects that can suppress lower airway inflammation. The decision to hospitalize should be based on the physician's clinical criteria (severity of the crisis and response to initial therapy), as well as social and behavioral factors of each patient.
RESUMO
BACKGROUNDS: Assessment of the presence and degree of reversibility of airflow obstruction is clinically important in patients with asthma or chronic obstructive pulmonary disease. The measurement of peak expiratory flow(PEF) is a simple, fast, and cheap method to assess the severity of obstruction and its degree of reversibility. Assessing the reversibility of airflow obstruction by peak expiratory flow(PEF) measurements would be is practicable in general practice, but its usefulness has not been well investigated. We compared PEF and FEV1 in assessing reversibility of airflow obstruction in patients with chronic obstructive pulmonary disease or asthma and developed a practical criterion for assessing the presence of reversibility in general practice. METHODS: PEF measurements were performed (Spirometry) in 80 patients(aged 24-78) with a history of asthma or chronic obstructive lung disease before and after the inhalation of 200 mg salbutamol. The change in PEF was compared with the change in forced expiratory volume in one second(FEV1). Reversible airflow obstruction was analysed analyzed according to American Thoracic Society(ATS) criteria. RESULTS: When defined as a 12% A 12% increase above the prebronchodilator value and a 200ml increase in either FVC or FEV1 reversibility was were observed in 45%(36) of the patients. Relative operating characteristic(ROC) analysis showed that an absolute improvement in PEF of 30l/min gave optimal discrimination between patients with reversible and irreversible airflow obstruction(the sensitivity and specificity of an increase of 30l/min in detecting a 12% increase above the prebronchodilator value and a 200ml increase in either FVC or FEV1 were 72.2% and 72.7% respectively, with a positive predictive value of 68.4%) CONCLUSIONS: Absolute changes in PEF can be used to diagnose reversible airflow obstruction.