Randomized, Double-blind, Placebo-controlled, Multicenter Study Comparing Ciprofloxacin DPI 32.5 mg BID (Twice a Day) Intermittently Administered for 28 Days on / 28 Days Off or 14 Days on / 14 Days Off Versus Placebo to Evaluate the Time to First Pulmonary Exacerbation and Frequency of Exacerbations in Subjects With Non-Cystic Fibrosis Bronchiectasis.

CompletadoFase 3ClinicalTrials.gov

ID: NCT02106832Tipo: INTERVENTIONALInicio: 30 de abr de 2014Fin estimado: 19 de oct de 2016

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate if the time to first pulmonary exacerbation of bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin for 28 days every other 28 days or for 14 days every other 14 days over 48 weeks.

Descripción detallada

Number of participants with Adverse events will be covered in Adverse Events section.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Patients with a proven and documented diagnosis of non CF idiopathic or post infectious bronchiectasis
Stable pulmonary status and stable regimen of standard treatment at least for the past 4 weeks

Criterios de exclusión

Forced expiratory volume in 1 second (FEV1) \<30% or \>90% predicted
Active allergic bronchopulmonary aspergillosis
Active and actively treated non tuberculosis mycobacterial (NTM) infection or tuberculosis
Primary diagnosis of Chronic obstructive pulmonary disease (COPD)

Intervenciones

drug

Ciprofloxacin (BAYQ3939) dry powder for inhalation

Ciprofloxacin dry powder for inhalation (DPI) 32.5 mg inhaled twice daily in cycles of 28 days on-treatment and 28 days off-treatment.

drug

Ciprofloxacin (BAYQ3939) dry powder for inhalation

Ciprofloxacin DPI 32.5 mg inhaled twice daily in cycles of 14 days on-treatment and 14 days off-treatment.

drug

Placebo

Matching placebo inhaled twice daily intermittently for 28 days on / 28 days off

drug

Placebo

Matching placebo inhaled twice daily intermittently for 14 days on / 14 days off

Ubicaciones

Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

Capital Federal, Ciudad Auton. de Buenos Aires, Argentina

Godoy Cruz, Mendoza Province, Argentina

Córdoba, Argentina

Vicente López, Argentina

Patrocinadores

PrincipalBayer

ColaboradorNovartis

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