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

November 20, 2023 updated by: Aradigm Corporation

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pediatrics

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ages 6-11 years
Drug: Antibiotic
Ages 12-17 years
Drug: Antibiotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum pharmacokinetics
Time Frame: Day 1
Day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Microbiological efficacy
Time Frame: Day 14
Day 14
Changes in spirometry
Time Frame: Days 1, 7, 14
Days 1, 7, 14
Quality of life (CFQ-R)
Time Frame: Days 1, 7, 14
Days 1, 7, 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aradigm Corporation

Investigators

  • Study Director: P Bruinenber, MD, Aradigm Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Estimated)

March 1, 2011

Study Completion (Estimated)

June 1, 2011

Study Registration Dates

First Submitted

March 11, 2010

First Submitted That Met QC Criteria

March 19, 2010

First Posted (Estimated)

March 23, 2010

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

August 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARD-3100-1001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cystic Fibrosis

Clinical Trials on Antibiotic

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe