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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Aradigm Corporation
ClinicalTrials.gov Identifier:
NCT01090908
First received: March 11, 2010
Last updated: August 27, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Cystic Fibrosis
Drug: Antibiotic

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Aradigm Corporation:

Primary Outcome Measures:
  • Serum pharmacokinetics [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Microbiological efficacy [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
  • Changes in spirometry [ Time Frame: Days 1, 7, 14 ] [ Designated as safety issue: Yes ]
  • Quality of life (CFQ-R) [ Time Frame: Days 1, 7, 14 ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: September 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ages 6-11 years Drug: Antibiotic
Ages 12-17 years Drug: Antibiotic

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

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pediatrics

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01090908

Sponsors and Collaborators
Aradigm Corporation
Investigators
Study Director: P Bruinenber, MD Aradigm Corporation
  More Information

No publications provided

Responsible Party: David E. Geller, M.D., Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT01090908     History of Changes
Other Study ID Numbers: ARD-3100-1001
Study First Received: March 11, 2010
Last Updated: August 27, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Ciprofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 22, 2014