Study to evaluate the safety and pharmacokinetics of ciprofloxacin following inhalation of ciprofloxacin dry powder for inhalation administered to pediatric patients with cystic fibrosis aged 12-17 years

• Conditions: long term treatment of chronic lung infections caused by Pseudomonas aeruginosa in patients with cystic fibrosis; MedDRA version: 8.1Level: LLTClassification code 10011763Term: Cystic fibrosis lung

• Registration Number: EUCTR2007-002912-24-DE
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

- Male or female subjects with cystic fibrosis confirmed by genetic testing and/or by sweat test;
- Colonization with P. aeruginosa confirmed in sputum in the past 12 months;
- 12 to 17 years of age;
- Normal body weight: BMI between 15 and 30 kg/m2;
- Subjects who are able to understand and follow instructions and who are able to participate in the study for the entire period;
- Women who are willing to use a method of contraception with a failure rate < 1% during the course of the study until the follow-up examination. These methods of contraception according to the note for guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP/ICH/286/95, modification) include consistent and correct use of hormone containing implants and injectables, combined oral contraceptives, hormone containing intrauterine devices, surgical sterilization, sexual abstinence and vasectomy or condom use by their partners.
- Subjects 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.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Participation in another clinical trial with antibiotic treatment during the preceding 2 weeks;
- Subjects with relevant conspicuous findings in medical history and pre-study examination not related to the underlying disease;
- Patients with FEV1 < 50%;
- Subjects with Burkholderia cepacia colonization of their respiratory tract;
- Subjects with acute pulmonary aspergillosis;
- Subjects on a lung transplant list;
- Subjects with acute pulmonary exacerbations;
- Subjects with severe liver cirrhosis;
- Massive hemoptysis in the preceding 4 weeks;
- Donation of more than 150 mL of blood in the preceding 4 weeks;
- Blood donation of approximately 500 mL in the preceding 3 months;
- A history of relevant diseases of vital organs, of the central nervous system, or other organs not related to the underlying disease;
- Subjects with a medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator or the sponsor;
- Febrile illness within 1 week before the start of the study;
- Subjects with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies;
- Subjects with hypersensitivity to the investigational drug or to other quinolones and/ or to inactive constituents;
- Regular daily consumption of more than 1 L of usual beer or the equivalent quantity of approximately 40 g of alcohol in another form;
- Regular daily consumption of more than 1 L of xanthine-containing beverages;
- Non-smoker;
- Use of medication within the 5 days preceding the study which could interfere with the investigational drug;
- Relevant deviation from the normal range in the clinical examination not related to the underlying disease;
- Relevant deviation from the normal range in clinical chemistry, hematology, or urinalysis not related to the underlying disease;
- Resting heart rate in the awake subject below 45 BPM;
- Systolic blood pressure below 100 mmHg or above 145 mmHg;
- Diastolic blood pressure above 95 mmHg;
- Relevant pathological changes in the ECG such as a second or third-degree AV block, prolongation of the QRS complex over 120 msec or of the QT / QTc-interval over 450 msec for men and over 470 msec for women;
- Concomitant inhalative therapy with antibiotics and/or concomitant systemic therapy with fluoroquinolones (see Section 4.5.7).
- Woman of childbearing potential not using safe and highly effective contraception methods as described in Section 4.2.2.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objective of the study is to investigate the safety and tolerability of inhaled ciprofloxacin given as single inhalation dose to pediatric CF patients. ;Secondary Objective: Secondary objective of the study is to investigate the pharmacokinetics of ciprofloxacin in plasma, urine and sputum after inhalative administration in order to show that an exposure needed for an assumed effective treatment of P. aeruginosa can be reached in the lung of pediatric CF patients.;Primary end point(s): not applicable