Abstract
Background: Clinical experience with Roflumilast in COPD is scarce in India
Aims and Objectives: To study the effect of Roflumilast as add-on to LABA/LAMA/ICS on lung function and exacerbation in patients with moderate to very severe COPD.
Method: clinical study of 118 COPD patients of GOLD stage II to IV with chronic cough and sputum production; 61 were treated with Roflumilast plus conventional treatment ( Group A) and 57 with conventional treatment only ( Group B) for 24weeks.
Patients developing adverse events and not completed study period were excluded. In group A/B (47/51) completed the study
Spirometry and CAT score were performed at the beginning and monthly for 24weeks. The primary endpoint was change in mean pre bronchodilator FEV1 from baseline, time to first exacerbation and the rates of exacerbation. Secondary endpoint was change in CAT score from baseline and to observe adverse events
Results: Roflumilast provided a sustained increase in mean pre bronchodilator FEV1 by 93ml over control group. Roflumilast prolonged time both to first and second exacerbations. A/B (22/12) patients did not experienced exacerbation. Roflumilast related adverse effects were diarrhoea in 3, insomnia in 1, tremors in 3 , dizziness in 3 patients.
Conclusion: study showed that Roflumilast improved lung function and reduced symptoms in patients treated concomitantly with conventional triple therapy. Roflumilast prolonged time to first exacerbation and further reduced mean exacerbation rate by 23%. Most patients tolerated Roflumilast well, though higher incidence of adverse events were seen.
- Copyright ©the authors 2016