- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00794586
Study Evaluating Fosfomycin/Tobramycin for Inhalation in Cystic Fibrosis Patients With Pseudomonas Aeruginosa Lung Infection
December 3, 2013 updated by: Gilead Sciences
A Phase 2, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Fosfomycin/Tobramycin for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Gilead is developing a broad spectrum combination antibiotic (FTI) consisting of fosfomycin (an antibiotic with activity against gram-positive and gram-negative bacteria) and tobramycin (an aminoglycoside antibiotic with potent gram-negative activity) for treatment of patients with CF.
FTI offers a potential option for treatment of CF lung infections.
It is important to note that the concentration of tobramycin in FTI is lower than that of the approved dose of inhaled tobramycin alone, thereby demonstrating the potential of FTI to minimize long-term toxicity from repeated exposure to aminoglycosides like tobramycin.
This study will 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.
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alaska
-
Anchorage, Alaska, United States, 99508
-
-
Arizona
-
Phoenix, Arizona, United States, 85016
-
Tucson, Arizona, United States, 85724
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
-
-
California
-
Palo Alto, California, United States, 94304
-
-
Colorado
-
Denver, Colorado, United States, 80206
-
-
Connecticut
-
Hartford, Connecticut, United States, 06102
-
New Haven, Connecticut, United States, 06520
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20010
-
-
Florida
-
Orlando, Florida, United States, 32803
-
Tampa, Florida, United States, 33606
-
-
Illinois
-
Chicago, Illinois, United States, 60614
-
Glenview, Illinois, United States, 60025
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
-
Boston, Massachusetts, United States, 02115
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
-
Detroit, Michigan, United States, 48201
-
-
Nevada
-
Las Vegas, Nevada, United States, 89107
-
-
New York
-
Albany, New York, United States, 12208
-
Buffalo, New York, United States, 14222
-
New Hyde Park, New York, United States, 11040
-
New York, New York, United States, 10032
-
Syracuse, New York, United States, 13210
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229
-
Cleveland, Ohio, United States, 44106
-
Columbus, Ohio, United States, 43205
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73112
-
-
Pennsylvania
-
Hershey, Pennsylvania, United States, 17033
-
Philadelphia, Pennsylvania, United States, 19102
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
-
-
Texas
-
Houston, Texas, United States, 77030
-
San Antonio, Texas, United States, 78212
-
-
Virginia
-
Portsmouth, Virginia, United States, 23708
-
Richmond, Virginia, United States, 23298
-
-
Washington
-
Tacoma, Washington, United States, 98405
-
-
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
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: FTI 80mg/20mg BID
Fosfomycin/Tobramycin combination 80mg/20 mg inhaled twice daily
|
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)
|
EXPERIMENTAL: FTI 160mg/40mg BID
Fosfomycin/Tobramycin combination 160 mg/40 mg inhaled twice daily
|
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_COMPARATOR: Placebo A BID
Placebo A inhaled twice daily
|
Volume-matched placebo inhaled twice daily for 28 days following 28 days of AZLI (Aztreonam Lysine for Inhalation).
|
PLACEBO_COMPARATOR: Placebo B BID
Placebo B inhaled twice daily
|
Volume-matched placebo inhaled twice daily for 28 days following 28 days of AZLI (Aztreonam Lysine for Inhalation).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Relative change in lung function from baseline at Day 28.
Time Frame: 28 Days
|
28 Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
November 1, 2008
Primary Completion (ACTUAL)
February 1, 2010
Study Completion (ACTUAL)
March 1, 2010
Study Registration Dates
First Submitted
November 18, 2008
First Submitted That Met QC Criteria
November 19, 2008
First Posted (ESTIMATE)
November 20, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
December 27, 2013
Last Update Submitted That Met QC Criteria
December 3, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GS-US-207-0103
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
-
Hospital de Clinicas de Porto AlegreUnknownCystic Fibrosis | Cystic Fibrosis Pulmonary Exacerbation | Cystic Fibrosis in Children | Cystic Fibrosis With ExacerbationBrazil
-
University of Colorado, DenverCystic Fibrosis FoundationTerminatedCystic Fibrosis-related Diabetes | Cystic Fibrosis Pulmonary Exacerbation | Cystic Fibrosis in ChildrenUnited States
-
Royal College of Surgeons, IrelandThe Hospital for Sick Children; Imperial College London; Erasmus Medical Center; University College Dublin and other collaboratorsActive, not recruitingCystic Fibrosis | Adherence, Medication | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis in Children | Cystic Fibrosis Liver DiseaseUnited Kingdom, Ireland
-
Herlev and Gentofte HospitalCopenhagen University Hospital, DenmarkActive, not recruitingMyocardial Infarction | Heart Diseases | Heart Failure | Stroke | Cystic Fibrosis | Heart Failure, Diastolic | Heart Failure, Systolic | Left Ventricular Dysfunction | Cystic Fibrosis-related Diabetes | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis of Pancreas | Cystic Fibrosis, Pulmonary | Cystic...Denmark
-
The Hospital for Sick ChildrenCanadian Cystic Fibrosis FoundationActive, not recruitingCystic Fibrosis | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis in ChildrenCanada
-
Arrowhead PharmaceuticalsTerminatedCystic Fibrosis, PulmonaryAustralia, New Zealand
-
AzurRx SASCompletedCystic Fibrosis | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis of PancreasTurkey, Hungary
-
Dartmouth-Hitchcock Medical CenterTrustees of Dartmouth CollegeWithdrawnCystic Fibrosis-related Diabetes | Cystic Fibrosis Liver Disease | CF - Cystic FibrosisUnited States
-
University Hospital, BordeauxCompleted
-
University of PortsmouthUniversity Hospital Southampton NHS Foundation Trust; Loughborough University; Queen Alexandra HospitalTerminated
Clinical Trials on FTI, AZLI
-
Gilead SciencesCompletedBronchiectasisUnited States, Belgium, Spain, Canada, Australia, Germany, United Kingdom, Netherlands, France, Italy
-
National Cancer Institute (NCI)CompletedUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Gilead SciencesCompletedBronchiectasisUnited States, Canada, Australia
-
Eiger BioPharmaceuticalsApproved for marketing
-
Gilead SciencesCovance; ClinPhone, Inc.; Chiltern International Inc.CompletedCystic FibrosisBelgium, France, Germany, Italy, Netherlands, Spain, United States, Ireland, United Kingdom, Portugal, Austria, Denmark, Switzerland
-
National Cancer Institute (NCI)CompletedRecurrent Adult Acute Myeloid Leukemia | Adult Acute Promyelocytic Leukemia (M3) | Childhood Myelodysplastic Syndromes | Previously Treated Myelodysplastic Syndromes | Recurrent Adult Acute Lymphoblastic Leukemia | Recurrent Childhood Acute Lymphoblastic Leukemia | Recurrent Childhood Acute Myeloid... and other conditionsUnited States
-
Gilead SciencesCompleted
-
National Cancer Institute (NCI)CompletedUnspecified Adult Solid Tumor, Protocol SpecificUnited States
-
H. Lee Moffitt Cancer Center and Research InstituteNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletedMultiple MyelomaUnited States
-
Gilead SciencesCompletedCystic Fibrosis | Pseudomonas AeruginosaSpain, United States, Germany, France, Italy, Poland