Safety and Efficacy of Tiotropium Rotacaps in Patients with COPD

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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 FEVimproved 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