European Journal of Biomedical and Pharmaceutical Sciences

A RANDOMIZED OPEN LABEL TRIAL TO COMPARE THE EFFICACY AND SAFETY OF FORMOTEROL AND BUDESONIDE WITH THAT OF MONTELUKAST AND BUDESONIDE IN STEP 3 TREATMENT OF ASTHMA

*Dr. Divya Gopalakrishnan, Dr. Anukesh Vasu Keloth, Dr. Puthiyaveetil Narayanan, Dr. Md Faiz Akram, Reshma Venugopal and Jayakrishna Prakash

ABSTRACT

Context: Choice between LABAs and LTRAs as add on drugs to low dose ICS in step 3 treatment of asthma remains unclear due to limited data on the comparative efficacy and safety of these two groups of drugs. Objectives: To compare efficacy and safety of Formoterol plus Budesonide with that of Montelukast plus Budesonide in step 3 treatment of asthma. Settings and design: Institution based randomized open label study. Materials and methods: 72 asthmatics satisfying selection criteria of the study were randomized to receive either inhaled Budesonide and Formoterol (FB group) or inhaled Budesonide and oral Montelukast (MB group) for 12 weeks. PEF value at end point was primary efficacy measure. Secondary efficacy measures were PEF values measured at the end of 1, 4 and 8 weeks and the end point values of FEV1, symptom scores, symptom free days/week, night awakenings/week , rescue puffs/week and rescue free days/week. Safety profile of the two treatments were based on adverse effects and laboratory parameters. Results: PEF value of FB group was significantly greater than that of MB group (p<0.05). FB group had significantly better results than MB group for FEV1 (p<0.05), total symptom scores (p<0.05), wheeze score (p<0.05), shortness of breath score (p<0.05), chest tightness score (p<0.05), night awakenings (p<0.05), symptom free days (p<0.05), rescue puff use (p<0.05) and rescue free days (p<0.05). Adverse effects were of similar frequency. Conclusion: Formoterol plus Budesonide is the better therapeutic option than Montelukast plus Budesonide for the step 3 treatment of asthma.

Keywords: Asthma control, Budesonide, Formoterol, Montelukast.