Comparison of safety and efficacy of the combination product QVA149A against the concurrent administration of the individual components, QAB149 and NVA237, in patients with chronic obstructive pulmon...

Update Il y a 4 ans
Reference: EUCTR2011-006050-91

Comparison of safety and efficacy of the combination product QVA149A against the concurrent administration of the individual components, QAB149 and NVA237, in patients with chronic obstructive pulmonary disease (COPD)

Woman and Man

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Extract

To evaluate the non-inferiority of QVA149 110/50 µg qd as compared to concurrent administration of QAB149 150 µg qd plus NVA237 50 µg qd in terms of its effect on trough FEV1 (mean of 23 h 15 min and 23 h 45 min post-dose) following 28 days of blinded treatment in patients with moderate to severe chronic obstructive pulmonary disease.


Inclusion criteria

  • Chronic Obstructive Pulmonary Disease (COPD)