Cipro Inhaler for Cystic Fibrosis Children Ages 6-12

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00910351
• Date of registration: 28/05/2009
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: Cipro Inhaler for Cystic Fibrosis Children Ages 6-12
• Scientific 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
• Date of first enrolment: July 2009
• Target sample size: 19
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00910351
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion 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



Age minimum: 6 Years
Age maximum: 12 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Pseudomonas Infection

Intervention(s)

Drug: Ciprofloxacin (Cipro, BAYQ3939)

Primary Outcome(s)

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(s)

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

Secondary ID(s)

12759

Source(s) of Monetary Support

Please refer to primary and secondary sponsors