Study Completed

Pseudomonas Infection

Bayer Identifier:

12759

ClinicalTrials.gov Identifier:

NCT00910351

EudraCT Number:

Not Available

EU CT Number:

Not Available

Cipro Inhaler for cystic fibrosis children ages 6-12

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

6 - 12 Years

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

Trial summary

Enrollment Goal

Trial Dates

July 2009 - October 2010

Phase

Phase 1

Could I Receive a placebo

Products

Ciprofloxacin DPI (BAYQ3939)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Children's Hospital Boston	Boston, 02115, United States
Completed	SUNY Upstate Medical University	Syracuse, 13210, United States
Completed	Johns Hopkins Hospital/Health System	Baltimore, 21287, United States
Completed	Emory University	Atlanta, 30322, United States

Primary Outcome

To investigate the safety and tolerability of inhaled ciprofloxacin given as single inhalation dose to pediatric CF patients, aged 6 - 12 years
Time Frame:
Two weeks post screening
Safety Issue:
yes

Secondary Outcome

To investigate the pharmacokinetics of ciprofloxacin in plasma and sputum after inhalation administration
Time Frame:
Day 1
Safety Issue:
yes

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Non-randomized

Blinding

Open Label

Assignment

Single Group Assignment

Trial Arms

Additional Information

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