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| Sponsor: | Gilead Sciences |
|---|---|
| Information provided by: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT00794586 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cystic Fibrosis |
Drug: FTI, AZLI Drug: Placebo, AZLI |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase 2, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Fosfomycin/Tobramycin for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa |
| Estimated Enrollment: | 120 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
FTI 80mg/20mg BID: Experimental
Fosfomycin/Tobramycin combination 80mg/20 mg inhaled twice daily
|
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)
|
|
FTI 160mg/40mg BID: Experimental
Fosfomycin/Tobramycin combination 160 mg/40 mg inhaled twice daily
|
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)
|
|
Placebo A BID: Placebo Comparator
Placebo A inhaled twice daily
|
Drug: Placebo, AZLI
Volume-matched placebo inhaled twice daily for 28 days following 28 days of AZLI (Aztreonam Lysine for Inhalation).
|
|
Placebo B BID: Placebo Comparator
Placebo B inhaled twice daily
|
Drug: Placebo, AZLI
Volume-matched placebo inhaled twice daily for 28 days following 28 days of AZLI (Aztreonam Lysine for Inhalation).
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with CF as diagnosed by one of the following:
Exclusion Criteria:
Abnormal renal or hepatic function or serum chemistry at Visit 1, defined as:
Contacts and Locations
Show 36 Study Locations| Principal Investigator: | Bruce Trapnell, MD | Children's Hospital Medical Center, Cincinnati |
More Information
| Responsible Party: | Gilead Sciences, Inc. ( A. Bruce Montgomery, Sr. VP Respiratory Therapeutics ) |
| Study ID Numbers: | GS-US-207-0103 |
| Study First Received: | November 18, 2008 |
| Last Updated: | November 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00794586 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
cystic fibrosis CF inhaled antibiotic antipseudomonal antibiotic tobramycin |
fosfomycin lung infection pseudomonal infection FTI |
|
Anti-Infective Agents Tobramycin Fibrosis Pharmacologic Actions Anti-Bacterial Agents Digestive System Diseases Pathologic Processes Fosfomycin |
Cystic Fibrosis Respiratory Tract Diseases Genetic Diseases, Inborn Therapeutic Uses Lung Diseases Pancreatic Diseases Infant, Newborn, Diseases |