Cipro Inhaler for Cystic Fibrosis Children Ages 6-12

NCT00910351 | Completed Phase 1 DMC

• 1 other identifier: 12759
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 4

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.

Conditions

Pseudomonas Infection

Keywords

Cystic Fibrosis; Pharmacokinetics; Pediatrics; Inhalation; Sputum

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Day 1

Study Arms (1)

Arm 1

EXPERIMENTAL

Drug: Ciprofloxacin (Cipro, BAYQ3939)

Interventions

Ciprofloxacin (Cipro, BAYQ3939) DRUG

25 mg inhaled Ciprofloxacin

Arm 1

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (4)

Unknown Facility

Atlanta, Georgia, 30322, United States

Location

Unknown Facility

Baltimore, Maryland, 21287, United States

Location

Unknown Facility

Boston, Massachusetts, 02115, United States

Location

Unknown Facility

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Pseudomonas Infections; Cystic Fibrosis; Respiratory Aspiration

Interventions

Ciprofloxacin

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2009
• First Posted: May 29, 2009
• Study Start: July 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: November 21, 2013

Record last verified: 2013-11

Locations

US (4)