RESUMEN
OBJECTIVE: This study assessed the delivery of tiotropium via Respimat® in addition to standard care of treatment among chronic obstructive pulmonary disease (COPD) patients. We study the efficacy, clinical outcome of handling inhaler device, rate of exacerbation and frequency of hospital admission of tiotropium via Respimat® with and without the use of a spacer (AeroChamber®). METHODS: Randomised, open-label study of COPD patients which was randomised into two groups: spacer or nonspacer groups using tiotropium via Respimat®. Treatment with their pre-existing inhalers continued. Subjects were assessed at weeks 0, and 8 for forced expiratory volume in 1 second (FEV1), COPD assessment tool (CAT), St. George's Respiratory Questionnaire (SGRQ), and satisfaction questionnaire. RESULTS: We enrolled 96 subjects: 49 in the spacer group and 47 in the non-spacer group. The mean predicted FEV1 in spacer group was 54.48% at baseline and 57.5l% at week 8: p=0.011. In the non-spacer groups, FEV1 was 54.48% at baseline and 59.20% with a mean increment of 4.72 in both groups: p=0.002. There were no difference of exacerbation rates and hospital admission between both groups. At baseline, mean CAT score in the spacer group was 14.01 which improved to 9.80 (p<0.001) and 14.01 to 8.80 (p<0.001) in the non-spacer group. SGRQ total score reduced in both groups with mean difference of 3.1 (p<0.001) and 3.7: (p<0.001) at weeks 0 to 8. CONCLUSION: There was no difference between exacerbation and hospital admissions between both groups. There was no difference in FEV1, CAT and SQRQ score using Tiotropium via Respimat® with or without a spacer.