ABSTRACT
Asthma is a heterogeneous disease, usually characterized by chronic airway inflammation, bronchoconstriction and airway hyper responsiveness. The addition of an inhaled corticosteroid (ICS) to an inhaled long-acting β2-agonist (LABA) gives optimal control of asthma in most patients. There are few international studies regarding efficacy and safety of LABA/ICS. But in India there is paucity of such studies. Hence the present study was undertaken.METHODSA comparative, prospective, observational study was conducted among 120 patients attending the Out Patient Department of Chest Medicine and Pharmacology of Burdwan Medical College and Hospital, diagnosed as having mild to moderate chronic stable persistent bronchial asthma, receiving combination of LABA and ICS therapy, out of which 16 patients were lost due to follow up, and 104 patients were studied. Patients were divided into 2 groups. Group A received respicaps of combined formoterol 6 μg and budesonide 400 μg DPI, Group B received combined formoterol 6 μg and mometasone 400 μg DPI, twice daily. During exacerbations inhaled salbutamol was utilized as rescue medication. Spirometric parameters, clinical parameters, and adverse effects were recorded on three visits (at 4th, 8th and 12th weeks) and analysed by using different statistical tests.RESULTSComparable clinical improvement of spirometric parameters, Asthma Control Test score of both groups were observed (p-value>0.05). Adverse effects like tremor, pharyngitis, headache, oral candidiasis and dysphonia were recorded among both the groups which was statistically insignificant.CONCLUSIONPatients who received ICS with LABA in both groups experienced a statistically significant improvement in symptoms. Improvement was seen in spirometric parameters as well with a comparable degree of safety