Cipro Inhaler for Cystic Fibrosis Children Ages 6-12

Pseudomonas Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00910351
• Other study ID #: 12759
• Status: Completed
• Phase: Phase 1
• First received: May 28, 2009
• Last updated: November 20, 2013
• Start date: July 2009
• Est. completion date: October 2010

Study information

• Verified date: November 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Pseudomonas Infection
• Pseudomonas Infections

Intervention

Drug:
• Ciprofloxacin (Cipro, BAYQ3939)
25 mg inhaled Ciprofloxacin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	To investigate the pharmacokinetics of ciprofloxacin in plasma and sputum after inhalation administration		Day 1	Yes

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