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Cipro Inhaler for Cystic Fibrosis Children Ages 6-12

Primary Purpose

Pseudomonas Infection

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ciprofloxacin (Cipro, BAYQ3939)
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pseudomonas Infection focused on measuring Cystic Fibrosis, Pharmacokinetics, Pediatrics, Inhalation, Sputum

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Outcomes

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

Secondary Outcome Measures

To investigate the pharmacokinetics of ciprofloxacin in plasma and sputum after inhalation administration

Full Information

First Posted
May 28, 2009
Last Updated
November 20, 2013
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00910351
Brief Title
Cipro Inhaler for Cystic Fibrosis Children Ages 6-12
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 Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pseudomonas Infection
Keywords
Cystic Fibrosis, Pharmacokinetics, Pediatrics, Inhalation, Sputum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin (Cipro, BAYQ3939)
Intervention Description
25 mg inhaled Ciprofloxacin
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
To investigate the pharmacokinetics of ciprofloxacin in plasma and sputum after inhalation administration
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States

12. IPD Sharing Statement

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Cipro Inhaler for Cystic Fibrosis Children Ages 6-12

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