ABSTRACT

Assessment of safety and efficacy of BroZedex syrup in the treatment of productive cough

Phase 111 Randomized Placebo Controlled Parallel Multicentre Study.

Acute bronchitis, acute exacerbations of chronic bronchitis, pneumonia and asthmatic bronchitis are often associated with productive cough.  Treatment of cough associated with expectoration is best accomplished by syrup that includes a mucolytic expectorant and probably a bronchodilator as well.

BroZedex syrup includes terbulatine sulphate a direct acting β2 receptor agonist, guaiphenesin an expectorant, Bromhexine a mucolytic and menthol a soothing agent. Terbutaline alleviates bronchospasm due to relaxation of bronchial smooth muscles leading to easier breathing by dilating airways. Bromhexine hydrochloride is a mucolytic and mucokinetic agent.  It reduces sputum viscosity. Guaiphenesin is an expectorant that acts by enhancing respiratory fluid output.  This increases the volume of secretions on respiratory tract to facilitate sputum removal.  Menthol acts as a demulcent and soothing agent.

This study proposes to demonstrate safety and efficacy of BroZedex in the treatment of productive cough associated with above conditions in our population.  The study will be conducted in three sites in Nairobi and 184 patients will be enrolled in the study.

The study patients will be put on either BroZedex or Placebo based on study number and allocated product based on computer generated randomization code.

The medication will be taken for 7 days and there will be three visits for the patients, day 1, 3 and 7. Subject assessment will be based on sputum consistency, severity of cough from baseline to end of study using a 4 point scale, onset of cough relief post first dose, change in breathlessness, volume of sputum, frequency of bouts of coughing, symptomatic relief rating daytime and night time cough score, and investigators and patients clinical global impression of change.

Patients will be given a subject diary for recording of assessed parameter.  All patients will be evaluated for vital signs when they undergo physical examination at all study visits.

The study will be conducted with the permission of IRB’s of KEMRI and Kenyatta National Hospital.  The study will be performed, respecting international and national ethical guidelines and after obtaining informed consent from each patient/parent/guardian.  Data generated will potentially inform on the safety and effectiveness of Bro-Zedex in the symptomatic management of productive cough in our population.