Study Evaluating Fosfomycin/Tobramycin for Inhalation in Cystic Fibrosis Patients With Pseudomonas Aeruginosa Lung Infection
NCT ID: NCT00794586
Last Updated: 2013-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
120 participants
INTERVENTIONAL
2008-11-30
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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FTI 80mg/20mg BID
Fosfomycin/Tobramycin combination 80mg/20 mg inhaled twice daily
FTI, AZLI
Evaluation of 2 dosage combinations of fosfomycin and tobramycin inhaled twice daily for 28 days following 28 days of inhaled AZLI (Aztreonam Lysine for Inhalation)
FTI 160mg/40mg BID
Fosfomycin/Tobramycin combination 160 mg/40 mg inhaled twice daily
FTI, AZLI
Evaluation of 2 dosage combinations of fosfomycin and tobramycin inhaled twice daily for 28 days following 28 days of inhaled AZLI (Aztreonam Lysine for Inhalation)
Placebo A BID
Placebo A inhaled twice daily
Placebo, AZLI
Volume-matched placebo inhaled twice daily for 28 days following 28 days of AZLI (Aztreonam Lysine for Inhalation).
Placebo B BID
Placebo B inhaled twice daily
Placebo, AZLI
Volume-matched placebo inhaled twice daily for 28 days following 28 days of AZLI (Aztreonam Lysine for Inhalation).
Interventions
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FTI, AZLI
Evaluation of 2 dosage combinations of fosfomycin and tobramycin inhaled twice daily for 28 days following 28 days of inhaled AZLI (Aztreonam Lysine for Inhalation)
Placebo, AZLI
Volume-matched placebo inhaled twice daily for 28 days following 28 days of AZLI (Aztreonam Lysine for Inhalation).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Bruce Trapnell, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
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Anchorage, Alaska, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Palo Alto, California, United States
Denver, Colorado, United States
Hartford, Connecticut, United States
New Haven, Connecticut, United States
Washington D.C., District of Columbia, United States
Orlando, Florida, United States
Tampa, Florida, United States
Chicago, Illinois, United States
Glenview, Illinois, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Las Vegas, Nevada, United States
Albany, New York, United States
Buffalo, New York, United States
New Hyde Park, New York, United States
New York, New York, United States
Syracuse, New York, United States
Chapel Hill, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Oklahoma City, Oklahoma, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Houston, Texas, United States
San Antonio, Texas, United States
Portsmouth, Virginia, United States
Richmond, Virginia, United States
Tacoma, Washington, United States
Countries
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Other Identifiers
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GS-US-207-0103
Identifier Type: -
Identifier Source: org_study_id