Cipro Inhaler for Cystic Fibrosis Children Ages 6-12

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00910351

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

4.8

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Ciprofloxacin PulmoSphere Inhalation Powder appears to be an effective and adequate antibiotic treatment for cystic fibrosis patients with P. aeruginosa colonisation. This planned study is the first study on the use of this new Ciprofloxacin PulmoSphere Inhalation Powder in the pediatric population of 6 to 12 years of age.

Condition or Disease	Intervention/Treatment	Phase
Pseudomonas Infection	Drug: Ciprofloxacin (Cipro, BAYQ3939)	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Study to Evaluate the Safety and Pharmacokinetics of Ciprofloxacin in Adults and Children Aged 6 - 12 Years With Cystic Fibrosis Following Inhalation of Ciprofloxacin Dry Powder

Study Start Date :

Jul 1, 2009

Actual Primary Completion Date :

Oct 1, 2010

Actual Study Completion Date :

Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Ciprofloxacin (Cipro, BAYQ3939) 25 mg inhaled Ciprofloxacin

Arm

Intervention/Treatment

Experimental: Arm 1

Drug: Ciprofloxacin (Cipro, BAYQ3939)

25 mg inhaled Ciprofloxacin

Outcome Measures

Primary Outcome Measures

To investigate the safety and tolerability of inhaled ciprofloxacin given as single inhalation dose to pediatric CF patients, aged 6 - 12 years [Two weeks post screening]

Secondary Outcome Measures

To investigate the pharmacokinetics of ciprofloxacin in plasma and sputum after inhalation administration [Day 1]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female patients with cystic fibrosis confirmed by genetic testing and / or by sweat test
Colonization with P. aeruginosa confirmed in sputum in the past 12 months
Cohort 1: greater than or equal to 18 years of age.
Cohort 2: 6 - 12 years of age (inclusive)
Normal Body Mass Index: BMI between 14.5 and 30 kg/m2, but in no case lower than the 30th percentile for age. Because CF patients are typically smaller than non-CF-patients, the normal body mass index will be based on standard CF foundation normal values for weight and sex.
Patients who are able to understand and follow instructions and who are able to participate in the study for the entire period.
Patients and legal representatives must have given their written informed consent to participate in the study after receiving adequate previous information and prior to any study specific procedures

Exclusion Criteria:

Patients with FEV1 < 35% of predicted. FEV1 (forced expiratory volume) is a measure of lung function. This exclusion will prohibit enrollment of patients with severely impaired lung function.
Patients with Burkholderia cepacia colonization of their respiratory tract
Patients with acute bronchopulmonary aspergillosis (ABPA)
Patients on a lung transplant list
Patients with acute pulmonary exacerbations
Patients with severe liver cirrhosis
Massive hemoptysis in the preceding 4 weeks
A history of relevant diseases of vital organs, of the central nervous system, or other organs not related to the underlying disease
Patients with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies
Patients with hypersensitivity to the investigational drug or to other quinolones and/ or to inactive constituents
Patients with known intolerance to hypertonic saline or bronchodilators
Concomitant inhalation therapy with antibiotics and / or concomitant systemic therapy with fluoroquinolones
Women who are pregnant