Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis

Update Il y a 4 ans
Reference: EUCTR2009-009869-34

Woman and Man

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Extract

The primary objective of this study in patients with non-CF bronchiectasis with positive sputum culture is to determine the effect of ciprofloxacin inhale on bacterial density, measured by decadic logarithm (log10) of reduction in colony forming units (CFUs) per gram sputum.


Inclusion criteria

  • Idiopathic and post-pneumonic non-Cystic Fibrosis Bronchiectasis in pulmonary stable patients (defined as FEV1 of > 35 % and < 80 percent of predicted)