Safety and Efficacy of Tiotropium + Formoterol in Patients with COPD
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18 Mar, 14

Tiotropium + Formoterol is Safe and Effective in Indian COPD Patients

Objective

  • To compare the bronchodilator response of Tiotropium + Formoterol (Duova, Cipla Ltd., India) combination vs. Tiotropium alone in COPD patients.

Patients and Methods

  • Randomised, double-blind, crossover study.
  • 24 male COPD subjects were included and randomised to either Tiotropium + Formoterol combination (18/12 mcg) or Tiotropium alone (18 mcg) on two separate days, atleast four days apart.

Results

Efficacy

  • Tiotropium + Formoterol produced a significantly better mean difference in area under the curve for both FEV1 and FVC when measured over 24 hours.

  • Tiotropium + Formoterol in combination showed a faster onset of action compared to Tiotropium alone.

  • Tiotropium + Formoterol in combination showed longer duration of action compared to Tiotropium alone.

  • The mean difference in the trough (24 hour values) from baseline were significantly better with Tiotropium + Formoterol in combination than Tiotropium alone
Difference from baseline in trough FEV1, FVC and IC values

Conclusion

  • Tiotropium + Formoterol provides better efficacy in terms of onset and duration of action, mean difference in AUC for FEV1 and FVC, mean differences in trough compared to Tiotropium alone.
  • Tiotropium + Formoterol in single inhaler improves compliance and convenience.

Presented at American College of Chest Physicians (ACCP) Annual meeting, 2005