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

Bayer HealthCare AG0 sites16 target enrollmentSeptember 5, 2007

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: long term treatment of chronic lung infections caused by Pseudomonas aeruginosa in patients with cystic fibrosis
Sponsor: Bayer HealthCare AG
Enrollment: 16
Status: Active, not recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

September 5, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- 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

•\- 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;