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

• Register: ClinicalTrials.gov
• Last refreshed on: 4 December 2023
• Main ID: NCT01090908
• Date of registration: 11/03/2010
• Prospective Registration: Yes
• Primary sponsor: Aradigm Corporation
• Public title: Evaluation of Ciprofloxacin for Inhalation to Cystic Fibrosis Patients With P. Aeruginosa
• Scientific 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
• Date of first enrolment: September 2010
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/ct2/show/NCT01090908
• Study type: Observational

Contacts

• Name: P Bruinenber, MD
• Affiliation: Aradigm Corporation

Key inclusion & exclusion 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.



Age minimum: 6 Years
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: Antibiotic

Primary Outcome(s)

Serum pharmacokinetics [Time Frame: Day 1]

Secondary Outcome(s)

Changes in spirometry [Time Frame: Days 1, 7, 14]

Microbiological efficacy [Time Frame: Day 14]

Quality of life (CFQ-R) [Time Frame: Days 1, 7, 14]

Secondary ID(s)

ARD-3100-1001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors