Cipro Inhaler for Cystic Fibrosis Children Ages 6-12

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00910351
Recruitment Status : Completed
First Posted : May 29, 2009
Last Update Posted : November 21, 2013
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Pseudomonas Infection Drug: Ciprofloxacin (Cipro, BAYQ3939) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Arm Intervention/treatment
Experimental: Arm 1 Drug: Ciprofloxacin (Cipro, BAYQ3939)
25 mg inhaled Ciprofloxacin

Primary Outcome Measures :
  1. 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 Measures :
  1. To investigate the pharmacokinetics of ciprofloxacin in plasma and sputum after inhalation administration [ Time Frame: Day 1 ]

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00910351

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
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer Identifier: NCT00910351     History of Changes
Other Study ID Numbers: 12759
First Posted: May 29, 2009    Key Record Dates
Last Update Posted: November 21, 2013
Last Verified: November 2013

Keywords provided by Bayer:
Cystic Fibrosis

Additional relevant MeSH terms:
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
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors