Cipro Inhaler for Cystic Fibrosis Children Ages 6-12 - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00910351

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 I

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:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

Drug Information available for: Ciprofloxacin Ciprofloxacin hydrochloride Ciprofloxacin lactate

U.S. FDA Resources

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

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:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Head Clinical Pharmacology, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT00910351 History of Changes
Other Study ID Numbers:	12759
Study First Received:	May 28, 2009
Last Updated:	November 20, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Cystic Fibrosis
Pharmacokinetics
Pediatrics
Inhalation
Sputum

Additional relevant MeSH terms:

Cystic Fibrosis
Fibrosis
Pseudomonas Infections
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

Gram-Negative Bacterial Infections
Bacterial Infections
Ciprofloxacin
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012