RESUMO
A randomized open label phase IV, non comparative trial according to GCP guidelines was conducted at the Dept. of Pulmonology, Jinnah postgraduate Medical Centre, Karachi between Dec 2001 - March 2002, to evaluate the efficacy of Montelukast [Singulair 10 mg 1x0.D] on 80 patients with mild to moderate asthma [FEV1 60-80% of predicted value], who were not well controlled on their Pre-trial therapy of combination Inhalers[Salbutamol + Beclomethasone] and to assess the reduction in usage frequency of fixed combination inhalers in these patients.Prior to randomization, all the patients had their Inhaler technique checked and were provided with Volumhalers if they were not using it previously. Patients who were not taking inhalers properly were excluded from study. Total duration of trial was 30 days with follow up after every 10 days. The results showed that at the end of 30 days 82% had occasional wheezes [no wheeze or having wheeze less than once a week], 79% had breathlessness less then one week or not at all.] 73% did not have nocturnal symptoms at end of trial while 72% patients. On day 30 were either not using fixed combination at all or were occasional users. The results concluded that patients with mild to moderate persistent asthma can be controlled with oral Montelukast resulting in marked reduction in usage of combination inhalers