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A 6-month, double-blind, double-dummy, randomised, parallel group, multicenter, efficacy and safety study of Symbicort® pMDI 2x160/4.5μg and 2x80/4.5μg bid compared to Formoterol Turbuhaler, Budesoni...

Update Il y a 4 ans
Reference: EUCTR2004-001183-41

A 6-month, double-blind, double-dummy, randomised, parallel group, multicenter, efficacy and safety study of Symbicort® pMDI 2x160/4.5μg and 2x80/4.5μg bid compared to Formoterol Turbuhaler, Budesonide pMDI (& the combination) and Placebo in chronic obstructive pulmonary disease patients (COPD)

Woman and Man

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Extract

To compare the efficacy (pre-post dose FEV1) of Symbicort® pMDI (pressurised Metered Dose inhaler) 2x 160/4.5μg/inhalation twice daily and of Symbicort® pMDI 2x 80/4.5μg/inhalation twice daily to its mono-products, formoterol Turbuhaler and budesonide pMDI, and placebo, over a 6-month period in patients with COPD.

Inclusion criteria

  • This is an application for a phase III study to be conducted in COPD patients

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