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

NCT01090908 | Withdrawn

• 1 other identifier: ARD-3100-1001
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• Serum pharmacokinetics

  Day 1

Secondary Outcomes (3)

• Microbiological efficacy

  Day 14

• Changes in spirometry

  Days 1, 7, 14

• Quality of life (CFQ-R)

  Days 1, 7, 14

Study Arms (2)

Ages 6-11 years

Drug: Antibiotic

Ages 12-17 years

Drug: Antibiotic

Interventions

Antibiotic DRUG

Ages 12-17 years; Ages 6-11 years

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatrics

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aradigm Corporation: lead

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• P Bruinenber, MD

  Aradigm Corporation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 11, 2010
• First Posted: March 23, 2010
• Study Start: September 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: June 1, 2011
• Last Updated: November 22, 2023

Record last verified: 2012-08