MedDataX Logo

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

NCT ID: NCT01090908

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cystic Fibrosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ages 6-11 years

Antibiotic

Intervention Type DRUG

Ages 12-17 years

Antibiotic

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Antibiotic

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Aradigm Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nemours Children's Clinic

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

P Bruinenber, MD

Role: STUDY_DIRECTOR

Aradigm Corporation

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ARD-3100-1001

Identifier Type: -

Identifier Source: org_study_id