Sanchay Kumar Biswas1, Mahmud Rahim2, Md. Rashidul Hassan3, Md. Ali Hossain4, Abdur Rouf5, Khairul Anam2, Nihar Ranjan Saha2, Md Sahen6, Md Alauddin7,Md Mostafijur Rahaman7
Abstract:
Background: Bronchodilation is the cornerstone in the management of
chronic obstructive pulmonary disease (COPD) and is based on regular treatment with long-acting once daily â2agonists (LABAs). A novel bronchodilator, Indacaterol, satisfies the requirements of an efficacious longacting â2 agonists with faster onset of action.
Method:The present study was a prospective, single blind, randomized controlled trial. After fulfilling the exclusion and inclusion criteria with prior written consent, 130 patients suffering from Chronic obstructive disease were recruited by purposive sampling from the patients attending in the outdoor and indoor of National Institute of diseases of the chest and Hospital. Group was allocated randomly and concealed, 50% in Indacaterol group,
50% Salmeterol/fluticasone proprionate group and maintained properly.Following 4 weeks run in and screening period during which baseline variables were assessed and concomitant medications were established. The primary efficacy variable was forced expiratory volume in first second (FEV1) as a lung function test and secondary efficacy variable was COPD Assessment Test (CAT) score. Then patients were randomized to receive either Indacaterol 150 ìg or Salmeterol/fluticasone proprionate 50/500 ìg. Tiotropium 18ìg in
both group was added as concomitant medication. Objective blinded
measurement of FEV1 and subjective measurement of symptoms by COPD
assessment Test were done in initial visit and during follow up at 4 weeks, 8 weeks, and at the end of 12 weeks.
Result:In the present study, 130 patients were randomized and 44(67.69%) patients in Group A(Indacaterol 150 ìg and 38(58.46) patients in Group B(Salmeterol/fluticasone proprionate 50/500 ìg) completed the study. Mean FEV1 change between two group in 1st visit was 12.57 ml (p<0.001),2nd visit 8.39 ml (p<0.01), final visit 20.26 ml (p<0.04)that was statistically significant.