CICLESONIDE IN ADDITION TO TIOTROPIUM AND FORMOTEROL IN MILD TO MODERATE CHRONIC OBSTRUCTIVE PULMONARY DISEASE: A RANDOMISED, DOUBLE BLIND STUDY

Divyesh R. Mandavia, V. Ghori, Ajay Savaliya, Jigna Dave, Narenda Paliwal and C. B. Tripathi* 

ABSTRACT

Introduction: Chronic obstructive pulmonary disease (COPD) is one of the most common lung disease characterised by chronic inflammation of bronchioles. There are very few evidences on use of pharmacotherapy, especially with inhaled corticosteroid, in COPD with FEV1 > 60%. Objective: This pilot study was designed to evaluate efficacy and safety of formoterol, tiotropium dual (FT/D) and formoterol, tiotropium, ciclesonide triple (FTC/T) combinations in the cases of COPD with FEV1 > 50%. Methods: This was 12 weeks, randomized, double-blind, parallel group study. COPD patients, 35 – 70 years old, with history of smoking ≥ 10 pack years, FEV1 > 50% of predicted and FEV1/FVC < 0.7 were included in this study. Eligible patients were randomly allocated to FT/D or FTC/T metered dose inhaler treatment groups in double blind manner. The pulmonary function test, six minute walk test (6 MWT) and adverse event profile were evaluated at every 4 weeks. Results: Forty-six (23 per group) subjects completed the study and analysed on intent to treat basis. There was significant improvement in FEV1 and 6 MWD within the group at 12 weeks in both the groups when compared to baseline, while there was not any significant difference between the groups. The FVC was significantly improved in FTC/T treatment group at 12 weeks compared to baseline. There was no significant difference in adverse drug reaction profiles between the groups. Conclusion: The present study suggests that addition of ciclesonide to formoterol and tiotropium does not improve lung function or exercise endurance more than bronchodilators alone. (CTRI/2011/091/000182).

Keywords: Ciclesonide, Tiotropium bromide, Formoterol, Mild to moderate COPD, Pulmonary function test, Six minute walk test.