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Establishing a relationship of causality between the medications received and the events occurred utilizing causality assessment scale is much needed to reduce the occurrence of Adverse Drug Reactions (ADRs) and to prevent exposure of patients towards additional drug hazards. Causality assessment can be defined as the determination of chance, whether a selected intervention is the root cause of the adverse event observed. The causality assessment is the responsibility of either a single expert or an established committee. As it is a common phenomenon of variable perception of knowledge and experience by each expert, there is a high possibility of disagreement and inter-individual variability on assessment. Many of the causality assessment methods have their advantages and disadvantages. However, no single scale has been adopted as standardized and considered for uniform acceptance.

BACKGROUND Bronchial asthma is a very common illness causing considerable mortality and morbidity. Long acting beta 2 agonists in combination with inhalation steroid is useful for reducing the severity of asthma. We have attempted to compare the efficacy of formoterol/budesonide and salmeterol/fluticasone combinations among patients of bronchial asthma. We wanted to compare the efficacy of Formoterol/Budesonide combination and Salmeterol/Fluticasone combination as Dry Powder Inhaler and Metered Dose Inhaler in patients with Bronchial Asthma in terms of asthma control and improvement in pulmonary function as assessed by FVC (%), FEV1 (%), FEV1/FVC (%), PEFR and Asthma Control Test (ACT) Score. METHODS This is a prospective, observational, non-interventional study conducted in Bronchial Asthma patients attending outpatient Respiratory Medicine Department of NRI General Hospital, Guntur. A total of 100 patients were included in the study. All the patients who were diagnosed with Asthma and who met the inclusion criteria and are prescribed with either Formoterol/Budesonide as DPI or MDI or Salmeterol/Fluticasone as DPI or MDI were reviewed for the efficacy of treatment. These different groups were created based on block randomization method. Initially base line PFT was performed and asthma control scores were obtained before treatment using GINA Guidelines. Reversibility of bronchoconstriction is assessed within 15 minutes of nebulization with 0.05% Salbutamol. After 15 days of PFT values and Asthma Control Scores were again obtained and compared with the base line values. Data analysis was conducted using paired ANOVA and t-test. RESULTS Of these 100 patients, 25 (25%) patients belong to Group-IA, 26 (26%) belong to Group-IB, 24 (24%) patients belong to Group-IIA and 25 (25%) patients belong to Group-IIB. After 2 weeks of treatment, PFT was repeated and asthma control scores were obtained. These obtained values were compared to baseline values. The improvement in lung function and the level of asthma control was assessed by performing PFTs and using Asthma Control Test Questionnaire. The corresponding Mean of FVC, FEV1, FEV1/FVC, PEFR and Asthma Control Score in the sample population using Formoterol/Budesonide DPI is more when compared to those using Formoterol/Budesonide MDI after 15 days of treatment with significant p-value of <0.05%. The corresponding Mean of FVC, FEV1, FEV1/FVC, PEFR and Asthma Control in the sample population using Salmeterol/Fluticasone DPI is more when compared to those using Salmeterol/Fluticasone MDI after 15 days of treatment with significant p-value of <0.05%. When sample population using Formoterol/Budesonide DPI is compared with sample population using Salmeterol/Fluticasone, the mean of FVC, FEV1, FEV1/FVC, PEFR and asthma control were significantly improved with a p-value of <0.05%. Pharmacoeconomic analysis showed that Group-IA (Formoterol/Budesonide DPI) is more effective with lesser cost of therapy when compared to other groups. This study reveals that Group-IA (Formoterol/Budeso...