PURPOSE:Long acting beta-2 agonists (LABAs) are prescribed for patients with persistent asthma and are sometimes used without inhaled corticosteroids (ICSs). However, no study supports their use as monotherapy instead of ICS. The aim of our study was to study the effectiveness of formoterol fumerate-a long acting beta-2 agonist as an alternative therapy to budesonide-an ICS in patients who were well controlled by ICS.
METHODS:A 20-week, randomised, single blind, controlled trial was conducted on 100 patients attending OPD of the Department of Tuberculosis and Chest Diseases at JNMCH, AMU, Aligarh from February 2004 to August 2007. The study group (n=50) were put on formoterol fumerate (12 micrograms twice daily) by MDI/DPI and control group (n=50) were continued on budesonide (400 micrograms twice daily). Patients were assessed at 2 weeks intervals for severity of symptoms, pulmonary function tests, exacerbations and sputum eosinophils. Patients developing exacerbation were discontinued from the trial and managed accordingly.
RESULTS:During the trial, no significant differences between the formoterol and budesonide groups were observed for conventional outcomes of clinical studies of asthma therapy-PEFR, FEV1 and night awakenings. However, formoterol group had more exacerbations than budesonide group [4/50(28%) vs 5/50(10%), p<0.01)] and a greater increase in mean eosinophils [-2% vs 4%, p<0.01)].
CONCLUSION:Patients with persistent asthma well controlled by low dose of budesonide cannot be switched to formoterol monotherapy without risk of loss of asthma control.
CLINICAL IMPLICATIONS:LABAs cannot substitute ICSs in the treatment of stable asthma.
DISCLOSURE:Quibtiya Syed, None.