A Study to Evaluate the Effectiveness of Inhaled Corticosteroid/Long-Acting Beta Agonist Combination and Assessment of Health-Related Quality of Life Among COPD Patients on this Therapy

Abstract

Background: Do combined inhalers offer additional benefits or harms in people with chronic obstructive pulmonary disease compared with the bronchodilator alone? The present study was conducted to evaluate the effectiveness of inhaled corticosteroid/long acting beta agonist combination and to assess the health related quality of life among COPD patients.  Methods: A prospective, comparative study was conducted in department of Pulmonary Medicine, Government Medical College and Rajindra Hospital, Patiala. A total of 80 patients were enrolled, and randomly allocated in two groups with 40 patients in each group. In group 1- Budesonide/formoterol (200/6 µg or 400/6 µg), and in group 2- Fluticasone/salmeterol (250/50 µg) was prescribed. The effectiveness was evaluated by assessing exacerbation rate, and breathlessness Modified Medical Research Council (mMRC) grade. Health related quality of life was assessed using St. George’s Respiratory Questionnaire (SGRQ). All the observations thus made were statistically analyzed using chi-square test and t-test.  Results: In present study, male patients (n=63) were more than female patients (n=17). In group 1 significant improvement was observed in breathlessness mMRC grade between visit 0 and 2 nd (x2 = 8.50, p=0.004), and between visit 1 st and 2 nd (x2 = 7.24, p=0.007). Similarly, among group 2, significant improvement was seen in mMRC grade between visit 0 and 2 nd (x2 = 8.39, p=0.004), and between visit 1 st and 2 nd  (x2 = 5.05, p=0.025). But, no significant difference was seen between group 1 and 2 mMRC grade (p > 0.05). There was no statistically significant difference between group 1 and group 2 exacerbation episodess (x2 = 2.13,p>0.05). In SGRQ mean total score, no significant difference was present between group 1 and 2 (p>0.05).  Conclusions: Budesonide Formoterol (BFC) and Fluticasone Salmeterol (FSC) belongs to same group of drug class i.e. inhaled corticosteroid with long acting beta agonist combination and are used to treat exacerbations in moderate to severe COPD patients. BFC and FSC are equally effective in present study.