Status Acronym ISRCTN EudraCT NCT (clinicaltrials.gov) DRKS
Active 2011-004208-39 NCT01764841

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.

Purpose / Objectives

Primary Outcome

  • Time to first exacerbation [ Time Frame: over 48 weeks after baseline ] [ Designated as safety issue: No ]
  • Exacerbation is defined by signs and symptoms plus intervention with systemic antibiotics

 

Secondary Outcomes

  • Mean number of exacerbations per patient per 48 weeks [ Time Frame: over 48 weeks after baseline ] [ Designated as safety issue: No ] Exacerbation is defined by signs and symptoms plus intervention with systemic antibiotics
  • Pathogens present at baseline and eradicated at 48 weeks [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]

  • Changes of Saint George's Respiratory Questionnaire score from baseline to 48 weeks [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]

  • New pathogens at 48 weeks, not present at baseline [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]

  • Changes of Forced expiratory volume in 1 second from baseline to 48 weeks [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]

  • Number of participants with Adverse events as a measure of safety and tolerability [ Time Frame: over 58 weeks after screening ] [ Designated as safety issue: Yes ]

 

Diagnosis

  • pathogenic bacteria
  • Cystic Fibrosis (1)

Target population

Age

18-99

Inclusion criteria

  • 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

 

Exclusion criteria

  • 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)

 

Study design

  • Phase III
  • Multicenter
  • Double-blind
  • Randomized
  • Placebo-controlled

Intervention

  • Drug: Ciprofloxacin DPI (BAYQ3939)
  • Drug: Placebo

 

Documents (password protected)

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Networks

Responsibilities in overall study

Sponsor

Bayer AG

  • Tel. +49 214 30-40126