Evaluation of Ciprofloxacin for Inhalation to Cystic Fibrosis Patients With P. Aeruginosa

Condition(s) targeted: Cystic Fibrosis

Phase: N/A

Status: Not yet recruiting

Sponsored by: Aradigm Corporation

Official(s) and/or principal investigator(s):
P Bruinenber, MD, Study Director, Affiliation: Aradigm Corporation

Overall contact:
P Bruinenberg, MD, Phone: 510-265-8838, Email: bruinenberg@aradigm.com

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.

Official title: A Multi-Center, Open Label Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Ciprofloxacin For Inhalation (CFI) Given Daily For 14 Days To Stable Cystic Fibrosis Patients Ages 6 To 17 With Pseudomonas Aeruginosa

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: Serum pharmacokinetics

Secondary outcome:

Microbiological efficacy

Changes in spirometry

Quality of life (CFQ-R)

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.

Minimum age: 6 Years. Maximum age: 18 Years. Gender(s): Both.

Criteria:

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.

P Bruinenberg, MD, Phone: 510-265-8838, Email: bruinenberg@aradigm.com

Starting date: September 2010
Last updated: April 1, 2010