Femme et Homme
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Extrait
The primary objectives of this study are • To evaluate the efficacy of ciprofloxacin DPI administered BID intermittently for 28 days on study treatment / 28 days off study treatment or 14 days on study treatment / 14 days off study treatment to prolong the time to first exacerbation requiring an intervention with systemic antibiotics in subjects with non–CF BE within 48 weeks after start of treatment ( as agreed with the US FDA [Food and Drug Administration]). • To evaluate the efficacy of ciprofloxacin dry powder for inhalation (DPI) administered 2 times a day (BID) intermittently for 28 days on study treatment / 28 days off study treatment or 14 days on study treatment / 14 days off study treatment in reducing the frequency of pulmonary exacerbation requiring an intervention with systemic antibiotics in subjects with non–CF BE (as agreed with EMA/ CHMP and Japan PMDA) within 48 weeks after start of treatment (wording harmonized with amendment no. 2).
Critère d'inclusion
- non-CF bronchiectasis