Safety and Efficacy of Tiotropium Rotacaps in Patients with COPD
18 Mar, 14
Tiotropium Rotacaps Is Safe And Effective In Indian Copd Patients
Objective
- To evaluate the safety and efficacy of Tiotropium Rotacaps (Tiova; 18 mcg; Cipla Ltd., India) using dry powder inhaler (Rotahaler; Cipla Ltd., India) in COPD patients over 4 weeks.
Patients and Methods
- An open, non-comparative, multicentre study.
- 120 moderate-to-severe COPD patients.
- Patients ≥ 40 years of age with smoking history of > 10 pack years.
- After a one-week run-in period, patients entered the treatment phase, during which they received Tiotropium 18 mcg OD in the morning using Cipla's dry powder inhaler for a period of 28 days.
- The trough FEV1 was measured 23-24 hours after the previous dose.
- Dyspnea, cough, sputum production and wheeze were assessed using a scoring system (0 = none, 1 = mild, 2 = moderate, 3 = severe).
Results
1. Efficacy
- The mean trough FEV1 improved by 130 ml at the end of treatment and FVC improved by 170 ml.
Mean Change in FEV1 & FVC on day 8 and day 29
- There was a significant improvement in the total symptom scores including 'dyspnea'.
- The improvement in PEFR was significantly greater at week 1 and week 4.
Change in Mean values of PEFR over 4 weeks of treatment (n=120)
2. Safety and Tolerability
- Except for dry mouth there were no significant adverse effects recorded.
Conclusion
-
Tiotropium administered as Rotacaps through the Cipla's dry powder inhaler is efficacious and well-tolerated in patients with COPD.
1930, presented at European Respiratory Society (ERS) Conference, 2005









