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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00794586
First received: November 18, 2008
Last updated: December 3, 2013
Last verified: December 2013

November 18, 2008
December 3, 2013
November 2008
February 2010   (final data collection date for primary outcome measure)
Relative change in lung function from baseline at Day 28. [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00794586 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study Evaluating Fosfomycin/Tobramycin for Inhalation in Cystic Fibrosis Patients With Pseudomonas Aeruginosa Lung Infection
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cystic Fibrosis
  • Drug: 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)
  • Drug: Placebo, AZLI
    Volume-matched placebo inhaled twice daily for 28 days following 28 days of AZLI (Aztreonam Lysine for Inhalation).
  • Experimental: FTI 80mg/20mg BID
    Fosfomycin/Tobramycin combination 80mg/20 mg inhaled twice daily
    Intervention: Drug: FTI, AZLI
  • Experimental: FTI 160mg/40mg BID
    Fosfomycin/Tobramycin combination 160 mg/40 mg inhaled twice daily
    Intervention: Drug: FTI, AZLI
  • Placebo Comparator: Placebo A BID
    Placebo A inhaled twice daily
    Intervention: Drug: Placebo, AZLI
  • Placebo Comparator: Placebo B BID
    Placebo B inhaled twice daily
    Intervention: Drug: Placebo, AZLI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
March 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00794586
GS-US-207-0103
Yes
Gilead Sciences
Gilead Sciences
Not Provided
Principal Investigator: Bruce Trapnell, MD Children's Hospital Medical Center, Cincinnati
Gilead Sciences
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP