Cipro Inhaler for Cystic Fibrosis Children Ages 6-12

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

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.

Study Overview

• Status: Completed
• Conditions: Pseudomonas Infection
• Intervention / Treatment: Drug: Ciprofloxacin (Cipro, BAYQ3939)

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
  • Maryland
    • Baltimore, Maryland, United States, 21287
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
  • New York
    • Syracuse, New York, United States, 13210

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
To investigate the pharmacokinetics of ciprofloxacin in plasma and sputum after inhalation administration	Day 1

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: May 28, 2009
• First Submitted That Met QC Criteria: May 28, 2009
• First Posted (Estimate): May 29, 2009

Study Record Updates

• Last Update Posted (Estimate): November 21, 2013
• Last Update Submitted That Met QC Criteria: November 20, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Cystic Fibrosis; Pediatrics; Inhalation; Sputum
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Pancreatic Diseases; Fibrosis; Cystic Fibrosis; Pseudomonas Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Ciprofloxacin
• Other Study ID Numbers: 12759