Clinical trial NCT01090908: Evaluation of Ciprofloxacin for Inhalation to Cystic Fibrosis Patients With P. Aeruginosa
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 type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cystic Fibrosis
Lead sponsor: Savara Inc.
Sponsor class: INDUSTRY
First posted: 2010-03-23
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatrics

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.

Eligibility 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.

Primary outcomes:
measure: Serum pharmacokinetics
timeFrame: Day 1
Secondary outcomes:
measure: Microbiological efficacy
timeFrame: Day 14
measure: Changes in spirometry
timeFrame: Days 1, 7, 14
measure: Quality of life (CFQ-R)
timeFrame: Days 1, 7, 14
Other outcomes:
Locations:
Study officials:
affiliation: Aradigm Corporation
name: P Bruinenber, MD
role: STUDY_DIRECTOR
References: