PURPOSE: A new fixed dose combination (FDC) of Cefixime (200 mg)+Erdostein(300 mg)(C+E) has been recently developed. This study was undertaken to compare the efficacy, safety and tolerability of this formulation and FDC of Amoxycillin (500 mg)+ Bromhexine(8 mg) (A+B)in Indian patients with acute exacerbations of chronic bronchitis(AECB).
METHODS: Adult patients (216) with AECB fulfilling the selection criteria were enrolled in this prospective double blind, randomized comparative study after approval by respective Institutional review boards(4). Patients were treated with one capsule of either C+E (110) bd or A+E(106) tds, for 10 days after obtaining their informed consent. Efficacy outcome were improvements in cough, sputum characteristics, dyspnea and auscultatory findings, microbiological and radiological improvements, physicians and patients’ global assessment of efficacy. Safety and tolerability was assessed through monitoring adverse events and laboratory tests.
RESULTS: A total 207 patients completed the study with 10 drop-outs (6 in C+E and 3 in A+B). An early significant relief was observed in the clinical signs and symptoms by day 3 in C+E compared to A+B. At the end of the study there was a significant reduction in cough (C+E −90.2% vs 83.6% (A+B)). A significantly greater number of patients in C+E reported no sputum(85.6% vs. 74.7% (A+B)). Percentage of patients with improved air entry was greater in C+E (90.4%) vs A+B(75.7%) as was reduction in FEV1(C+E(79.0%) vs.73.3%(A+B)). Foreign sounds like ronchi and wheezing improved significantly. As per both physicians’ and patients’ assessments therapy was rated as excellent in a 46.2% and 49% respectively patients in C+E compared to A+B(28.2% and 33% respectively). Diarrhea was reported in a fewer 9.1% patients in the C+E compared to 14.2% in A+B. No abnormalities were reported in laboratory parameters.
CONCLUSION: Therapy with the FDC of Cefixime+ Erdosteine b.d. resulted in a faster and better symptomatic relief of AECB compared to the FDC of Amoxicillin +Bromhexine t.d.s and was also better tolerated.
CLINICAL IMPLICATIONS: FDC of C+E is a better therapeutic option compared to the FDC of A+B in patients with AECB.
DISCLOSURE: Akhilesh Sharma, No Product/Research Disclosure Information; Employee Dr Akhilesh Sharma and Dr Vidyagauri Baliga are full time employees of Glenmark Pharmaceuticals Ltd.