Cystic Fibrosis
Conditions
Brief summary
This is a Phase 1/2a, multicenter study, designed to evaluate the pharmacokinetics, safety, and tolerability of once daily administration of 150 mg of Ciprofloxacin for Inhalation (CFI) in patients with Cystic Fibrosis who have a history of chronic P. aeruginosa lung infection.
Detailed description
This is a Phase 1/2a, multicenter study, designed to evaluate the pharmacokinetics, safety, and tolerability of once daily administration of 150 mg of Ciprofloxacin for Inhalation (CFI) in patients with Cystic Fibrosis who have a history of chronic P. aeruginosa lung infection. Patients will be enrolled and followed in this study for 1 month. This study will consist of a Screening Phase, a Treatment Phase consisting of a 14 days, and a Follow up Phase consisting of a 14 days Off-treatment Period.
Interventions
DRUGAntibiotic
Sponsors
Aradigm Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* 6 to 17 years of age (inclusive) at Visit 1. * Positive sputum culture for P. aeruginosa * Clinical diagnosis of CF * FEV1 greater than or equal to 40% predicted normal lung function * Able to perform spirometry testing reproducibly according to ATS guidelines.
Exclusion criteria
* Use of an investigational agent within 30 days prior to Visit 1 (first dosing visit). * History of sputum culture or deep-throat cough swab (or BAL) culture yielding Burkholderia cepacia (B. cepacia), within 2 years prior to screening and/or sputum culture yielding B. cepacia at the Screening visit; * Use of any nebulized or systemic antibiotics within 14 days prior to Visit 1, other than maintenance oral macrolides that has been consistently used for at least 28 days prior to Visit 1. * History of intolerance or hypersensitivity to quinolone or fluoroquinolone class antibiotics * History of lung transplantation. * AST, ALT or total bilirubin \> 3 x upper limit of normal at screening. * History of hemoptysis \> 30 cc per episode during the 28 days prior to Visit 1. * Other present conditions, abnormality in screening laboratory tests or physical examination findings, that in the opinion of the Investigator or Medical Monitor would compromise the safety of the patient or the quality of the data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum pharmacokinetics | Day 1 |
Secondary
| Measure | Time frame |
|---|---|
| Microbiological efficacy | Day 14 |
| Changes in spirometry | Days 1, 7, 14 |
| Quality of life (CFQ-R) | Days 1, 7, 14 |
Outcome results
None listed