Study Evaluating Fosfomycin/Tobramycin for Inhalation in Cystic Fibrosis Patients With Pseudomonas Aeruginosa Lung Infection

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of 2 dose combinations of fosfomycin/tobramycin for inhalation (FTI), following a 28-day course of Aztreonam for Inhalation (AZLI) in patients with cystic fibrosis and Pseudomonas aeruginosa lung infection.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Fosfomycin; Tobramycin

Criteria

Inclusion Criteria:

• Males or females aged 18 years and older

• Patients with CF as diagnosed by one of the following:

• Documented sweat chloride greater than or equal to 60 mEq/L by quantitative pilocarpine iontophoresis test, OR

• Documented sweat sodium greater than or equal to 60 mmol/L, OR

• Abnormal nasal potential difference, OR

• Two well-characterized genetic mutations in the CF transmembrane conductance regulator (CFTR) gene, AND

• Accompanying symptoms characteristic of CF

• Documented presence of PA in an expectorated sputum or throat swab culture at Visit 1 OR documented PA in 2 expectorated sputum or throat swab cultures within 12 months prior to Visit 1; one of the previous PA-positive cultures must be within 3 months prior to Visit 1

• Patients must be able to provide written informed consent prior to any study related procedures

• FEV1 greater than or equal to 25% and less than or equal to 75% predicted at Visit 1

• Ability to perform reproducible pulmonary function tests

• Chest radiograph at Visit 1 without significant acute findings (e.g., infiltrates [lobar or diffuse interstitial], pleural effusion, pneumothorax); or chest radiograph, CT, or MRI obtained within the 90 days prior to Visit 1 without acute findings or significant intercurrent illness; chronic, stable findings (e.g., chronic scarring or atelectasis) are allowed.

Exclusion Criteria:

• Current use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone a day or 20 mg prednisone every other day

• History of sputum or throat swab culture yielding B. cepacia in the previous 2 years

• Current requirement for daily continuous oxygen supplementation or requirement for more than 2 L/minute at night

• Administration of any investigational drug or device within 28 days of Visit 1 or within 6 half-lives of the investigational drug (whichever is longer)

• Known local or systemic hypersensitivity to monobactam antibiotics

• Known allergies/intolerance to tobramycin or other aminoglycosides

• Known allergies/intolerance to fosfomycin

• Inability to tolerate inhalation of a short acting beta2 agonist

• Changes in or initiation of chronic azithromycin treatment within 14 days prior to Visit 1

• Administration of antipseudomonal antibiotics by inhalation, IV, or oral routes within the 14 days prior to Visit 1

• Changes in antimicrobial, bronchodilator (BD), corticosteroid, hypertonic saline, or dornase alfa medications within 7 days prior to Visit 1

• Changes in physiotherapy technique or schedule within 7 days prior to Visit 1

• History of lung transplantation

• Abnormal renal or hepatic function or serum chemistry at Visit 1, defined as:

• AST, ALT > 3 times upper limit of normal range (ULN)

• Creatinine > 1.5 times ULN

• Positive pregnancy test at Visit 1; all women of childbearing potential will be tested

• Female patients of childbearing potential who are lactating or are not (in the opinion of the investigator) practicing an acceptable method of birth control; female patients who utilize hormonal contraceptives as a birth control method must have used the same method for at least 3 months before study dosing

• Any serious or active medical or psychiatric illness, which in the opinion of the investigator, would interfere with patient treatment, assessment, or compliance with the protocol