Evaluation of Cipro Inhale in Patients With Non-cystic Fibrosis Bronchiectasis

Bayer

Status and phase: Completed; Phase 2

Conditions: Bronchiectasis

Treatments: Drug: Placebo; Drug: Ciprofloxacin (Cipro, BAYQ3939)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00930982

2009-009869-34 (EudraCT Number)

12965

Details and patient eligibility

About

The purpose of this study is to find out if bacterial load in the airways can be reduced after inhalation of ciprofloxacin for 28 days.

Full description

Safety issues are addressed in the AE section. There is no standardised and unanimously accepted definition of exacerbation in COPD; 4 definitions are widely used: (1) using a combination of 3 cardinal symptoms: increased dyspnea, sputum volume, and sputum purulence; (2) looking at the presence of the following patterns of symptoms during >=2 consecutive days: either 2 or more of 3 major symptoms (increase in dyspnoea, sputum volume and sputum purulence); or any 1 major symptom together with any 1 minor symptom (increase in nasal discharge, wheeze, sore throat, cough or fever); (3) a sustained worsening of the patient's condition, from the stable state and beyond normal day-to-day variations, that is acute in onset and necessitates a change in regular medication in a patient with underlying COPD; (4) a complex of respiratory events (i.e. cough, wheezing, dyspnoea or sputum production) lasting >=3 days.

Enrollment: 124 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a proven and documented diagnosis of non-cystic fibrosis idiopathic or post pneumonic bronchiectasis
• Stable pulmonary status and stable regimen of standard treatment at least for the past 30 days

Exclusion criteria

• Forced Expiratory Volume 1 < 35% or > 80%
• Allergic bronchopulmonary aspergillosis
• Immunodeficiency disease requiring immunoglobulin replacement
• Inflammatory bowel disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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124 participants in 2 patient groups, including a placebo group

Ciprofloxacin Inhale (BAYQ3939)

Experimental group

Description:

32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily

Treatment:

Drug: Ciprofloxacin (Cipro, BAYQ3939)

Placebo

Placebo Comparator group

Description:

Inhalation of matching placebo twice a day

Treatment:

Drug: Placebo