Cipro Inhaler for Cystic Fibrosis Children Ages 6-12

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00910351
First received: May 28, 2009
Last updated: November 20, 2013
Last verified: November 2013
  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.


Condition Intervention Phase
Pseudomonas Infection
Drug: Ciprofloxacin (Cipro, BAYQ3939)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bayer:

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 [ Time Frame: Two weeks post screening ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To investigate the pharmacokinetics of ciprofloxacin in plasma and sputum after inhalation administration [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]

Enrollment: 19
Study Start Date: July 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Ciprofloxacin (Cipro, BAYQ3939)
25 mg inhaled Ciprofloxacin

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00910351

Locations
United States, Georgia
Atlanta, Georgia, United States, 30322
United States, Maryland
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Boston, Massachusetts, United States, 02115
United States, New York
Syracuse, New York, United States, 13210
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00910351     History of Changes
Other Study ID Numbers: 12759
Study First Received: May 28, 2009
Last Updated: November 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Cystic Fibrosis
Pharmacokinetics
Pediatrics
Inhalation
Sputum

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pseudomonas Infections
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Ciprofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 18, 2014