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A two part, double blind, placebo controlled, study to assess the safety, tolerability, pharmacokinetics and pharmacodynamic effects of multiple doses of QBM076 in patients with COPD

Update Il y a 4 ans
Reference: EUCTR2012-005615-92

Woman and Man

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Extract

Part 1: To evaluate the safety and tolerability of multiple ascending doses of QBM076 in current or ex-smoking patients with stable COPD with spirometry grades I-III (according to the current GOLD strategy (GOLD 2013)) for 14 consecutive days of treatment. Part 2: To evaluate the preliminary efficacy of 8 consecutive weeks of QBM076 in current or ex-smoking patients with stable COPD with spirometry grades I-III (according to the current GOLD strategy (GOLD 2013)). 1. LCI; 2. absolute neutrophil count in sputum; 3. spirometry FEV1; 4. TDI.

Inclusion criteria

  • Chronic Obstructive Pulmonary Disease (COPD)

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