Gundeep Dhillon, MD, MPH
Gilead FTI Study
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
This is a clinical research study involving two experimental drugs, aztreonam for inhalation solution (AZLI, study drug), and fosfomycin/tobramycin for inhalation (FTI, study drug) for the treatment of Pseudomonas aeruginosa (PA) infection in patients with cystic fibrosis (CF). The purpose of the research study is to find out if FTI is safe and effective in patients with CF and Pseudomonas aeruginosa (PA) infection after a 28 day course of AZLI.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Aztreonam for Inhalation Solution (AZLI)
- Drug: FTI
Phase:
Phase 2Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
x Males or females aged 18 years and older
x Patients with diagnosis of CF as confirmed by at least one of the following:
- Documented sweat chloride ??60 mEq/L by quantitative pilocarpine iontophoresis test OR
- Documented sweat sodium test ??60 mmol/L OR
- Abnormal nasal potential difference test OR
- Two well-characterized, disease-causing genetic mutations in the CF transmembrane conductance regulator (CFTR) gene AND
- Accompanying symptoms characteristic of CF
x 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
x Patients must be able to provide written informed consent prior to any study related
procedures
x FEV1 ??25% and ??75% predicted at Visit 1
x Ability to perform reproducible pulmonary function tests
x 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
Key Exclusion Criteria:
x Current use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone a day or 20 mg prednisone every other day
x History of sputum or throat swab culture yielding B. cepacia in the previous 2 years protocol
x Current requirement for daily continuous oxygen supplementation or requirement for more than 2 L/minute at night
x 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)
x Known local or systemic hypersensitivity to monobactam antibiotics
x Known allergies/ intolerance to tobramycin or other aminoglycosides
x Known allergies/intolerance to fosfomycin
x Inability to tolerate inhalation of a short acting E2 agonist
x Changes in or initiation of chronic azithromycin treatment within 14 days prior to Visit 1
x Administration of antipseudomonal antibiotics by inhalation, IV, or oral routes within the
14 days prior to Visit 1
x Changes in antimicrobial, bronchodilator (BD), corticosteroid, hypertonic saline, or dornase alfa medications within 7 days prior to Visit 1
x Changes in physiotherapy technique or schedule within 7 days prior to Visit 1
x History of lung transplantation
x 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
x Positive pregnancy test at Visit 1; all women of childbearing potential will be tested
x 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
x 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
Additional Study Details
Official Title:
A Phase 2, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Fosfomycin/Tobramycin for Inhalation in Patients with Cystic Fibrosis and Pseudomonas aeruginosaAnticipated start date:
6/4/2009Lead Sponsor:
Gilead Sciences, Inc.Investigator(s):
- Richard B Moss
- Carlos Milla
- Carol K. Conrad
- Terry Earl Robinson
- Paul K Mohabir
- David Weill
- Gundeep Dhillon MD
- John David Mark
- Martha Hamilton
- Zoe Davies RN
- Yan Ki Angela Leung
- Viji Mahathevan
- Dr. Jacquelyn Marie Zirbes DNP
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- microbiology parameters, relative change from baseline (Day 0) in FEV1 % predicted at Day 28
Secondary Outcomes:
- Change from baseline in FEV1, FVC, and FEF25-75 at Day 28, respiratory symptoms domain of the CFQ-R at Day 28, non-respiratory domains of the CFQ-R, Proportion of patients hospitalized and number of days patients were hospitalized during the study, Proportion of patients requiring non-study drug antipseudomonal antibiotics (including IV, inhaled or oral), Percentage of missed school/work days due to CF during the course of the study
Total Number to be Enrolled:
120Total Number to be Enrolled at Stanford:
2More Information
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
7/27/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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