RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, CROSS-OVER STUDY TO INVESTIGATE THE BRONCHODILATOR EFFICACY AND SAFETY AFTER SINGLE AND REPEATED ADMINISTRATIONS OF DIFFERENT DOSES OF GLYCOPYRROLATE VIA ...

Update Il y a 4 ans
Reference: EUCTR2010-018668-18

RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, CROSS-OVER STUDY TO INVESTIGATE THE BRONCHODILATOR EFFICACY AND SAFETY AFTER SINGLE AND REPEATED ADMINISTRATIONS OF DIFFERENT DOSES OF GLYCOPYRROLATE VIA PMDI IN MODERATE TO SEVERE COPD PATIENTS. (GLYCO 2)

Woman and Man

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Extract

PART I • To assess the safety and tolerability of single administration of Glyco pMDI at 5 dose levels in patients with moderate to severe COPD PART II • To assess the bronchodilator efficacy of Glyco pMDI at 3 dose levels by comparison with placebo in patients with moderate to severe COPD after repeated administration


Inclusion criteria

  • COPD