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A randomized, double-blind, placebo-controlled, 4 period incomplete block cross-over, multi-center, multiple dose (7 days) dose-ranging study to assess the efficacy and safety of 4 doses of NVA237 in ...

Mise à jour : Il y a 5 ans
Référence : EUCTR2007-000642-13

A randomized, double-blind, placebo-controlled, 4 period incomplete block cross-over, multi-center, multiple dose (7 days) dose-ranging study to assess the efficacy and safety of 4 doses of NVA237 in patients with stable Chronic Obstructive Pulmonary Disease (COPD), compared to seven days treatment with tiotropium (18µg once daily, open label) as an active control

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Extrait

To evaluate the bronchodilatory efficacy of NVA237 in patients with stable COPD in terms of through FEV1 (mean of 23h 15 min & 23h 45 min post dose) following 7 days of treatment, by comparing four doses of NVA237 (12.5, 25, 50 &100 micrograms o.d.) with placebo delivered by the single Dose Dry Powder Inhaler (SDDPI).

Critère d'inclusion

  • Chronic Obstructive Pulmonary Disease (COPD)

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