check_circleStudy 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
  • - 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
  • - 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
19
Trial Dates
July 2009 - October 2010
Phase
Phase 1
Could I Receive a placebo
No
Products
Ciprofloxacin DPI (BAYQ3939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Children's Hospital BostonBoston, 02115, United States
Completed
SUNY Upstate Medical UniversitySyracuse, 13210, United States
Completed
Johns Hopkins Hospital/Health SystemBaltimore, 21287, United States
Completed
Emory UniversityAtlanta, 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
    date_rangeTime Frame:
    Two weeks post screening
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • To investigate the pharmacokinetics of ciprofloxacin in plasma and sputum after inhalation administration
    date_rangeTime Frame:
    Day 1
    enhanced_encryption
    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
1

Additional Information

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