Abstract

COPD is the major cause of chronic morbidity & mortality throughout the world as well as Bangladesh. The varieties of treatment options are followed in order to improve lung function, health status changes and prevent exacerbations. These include long-acting inhaled bronchodilators, such as salmeterol and tiotropium, as well as inhaled corticosteroids (ICS) alone or combined with long-acting β₂-agonists.

Objective: The present study is design to evaluate lung function, health status changes and prevention of exacerbations following treatment with twice daily salmeterol/fluticasone propionate combination (SFC) compare with once daily tiotropium bromide (Tio) in COPD patient.

Material and Methods: Initially 100 patients were included according to the inclusion and exclusion criteria of the study. A 2-weeks phase of run-in period was performed in order to evaluate with history and symptoms, examinations and certain baseline investigations, spirometry and SGRQ evaluation were done. During the run-in period all study patients were provided with any treatment with inhaled corticosteroids, short-acting bronchodilator, long-acting β₂-agonists, and anticholinergics that the patients may be using before was discontinued. After, randomization patients gave rotacap according to their code number. Than a baseline, at the end of the 2^nd& 12^th week follow-up was done to determine the improvement of symptoms by MRC dyspnoea scale, lung function by spirometry FEV1, health status changes by SGRQ evaluation, as well as status of exacerbation and need hospitalization. During the study period total 79 patients completed the procedure & came to the final follow-up.

Results: After analysis it was found that 38 patients were received SFC & 41 patients were received Tio. Patients who received SFC, the post-bronchodilator FEV1 improvement was 7.2±4.1 & who received Tio it was 2.9±1.4. Regarding health status changes, it was observed that significant improvement i.e. >4 unit changes of total score, activity scoresymptoms score,& impact score occur in the patients who received SFC than Tio. During study period 5.3% patients suffered from exacerbation & 2.6% patients required hospitalization in SFC group but in Tio group it was 9.8% & 4.9% respectively.

Conclusion: SFC group experienced higher improvement of symptoms, lung function, health status changes, fewer exacerbations & less required hospitalization during the clinical trial. Concerning about the exacerbation prevention of the relative risk reduction was 46%, absolute risk reduction was 4.5%, and NNT was 22. Regarding hospitalization prevention among the patients, the relative risk reduction was 47%, absolute risk reduction was 2.3%, and NNT was 43.

Keywords: COPD, Salmeterol,Tiotropium Bromide.