Aztreonam for Inhalation Solution (AZLI) vs Tobramycin Inhalation Solution (TOBI®) in Patients With CF & P. Aeruginosa
Information source: Gilead Sciences
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cystic Fibrosis; Anti-Infective Agents; Anti-Bacterial Agents; Pathologic Processes; Therapeutic Uses; Infection; Pharmacologic Actions; Fibrosis
Intervention: Aztreonam for Inhalation Solution (Drug); Tobramycin Nebuliser Solution (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Gilead Sciences Official(s) and/or principal investigator(s):
Mark Bresnik, MD, Study Director, Affiliation: Gilead Sciences
Overall contact:
Crystal Green, Phone: 206.832.2092, Email: AZLI-CF@gilead.com
Summary
The purpose of this study is to assess the comparative safety and effectiveness of Aztreonam
for Inhalation Solution versus Tobramycin Nebuliser Solution in adult and pediatric patients
with CF and pulmonary Pseudomonas aeruginosa (PA) infection.
Clinical Details
Official title: Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of AZLI Versus TOBI® in an Intermittent Aerosolized Antibiotic Regimen in Patients With CF (US and EU), Followed by an Open-Label, Single Arm Extension (EU)
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To assess the comparative safety and efficacy of Aztreonam for Inhalation Solution (AZLI) and Tobramycin Nebuliser Solution (TNS) in adult and pediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.
Detailed description:
Number of Subjects Planned: Approximately 200 randomized patients
Target Population: CF patients >/= 6 years of age with stable pulmonary disease, who at
study entry have a recent positive sputum culture for PA and have been previously treated
with aerosolized antibiotics without demonstration of drug intolerance.
U. S Only
Study Design: This is an open-label, multicenter, randomized, parallel group study. The
study design consists of two treatment arms of 28-day, intermittent, repeating treatment
regimens: Aztreonam for Inhalation Solution (AZLI) or Tobramycin Inhalation Solution (TIS).
The total study period will be 26 weeks. The study schedule will include nine visits -
Screening, Baseline, Day 14, Day 28, then visits every 28 days through the end of the study.
EU Only
Study Design: This is an open-label, multicenter, randomized, parallel group study. The
study design consists of two treatment arms of 28-day, intermittent, repeating treatment
regimens: Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) or Tobramycin
Nebuliser Solution (TNS). The total study period will be 26 weeks. The study schedule will
include nine visits - Screening, Baseline, Day 14, Day 28, then visits every 28 days through
the end of the study.
An open-label, single-arm extension is available for subjects who have completed at least
one course of AZLI or TNS during the randomized portion of the study. Subjects may be
eligible to receive three additional cycles of AZLI in a 28-day, intermittent, repeating
treatment regimen.
Eligibility
Minimum age: 6 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Males or females aged 6 years and older
- Patients with CF as diagnosed by one of the following:
- Documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine
iontophoresis test, or
- Documented sweat sodium ≥ 60 mmol/L, or
- Two well characterized genetic mutations in the Cystic Fibrosis Transmembrane
Conductance Regulator (CFTR) gene, or
- Abnormal nasal potential difference with accompanying symptoms characteristic of CF
- Documented PA in an expectorated sputum or throat swab culture within 3 months prior
to Visit 1 or at Visit 1
- Patients must be able to provide written informed consent/assent prior to any study
related procedures; parent/guardian must be able to give written informed consent as
necessary prior to any study related procedure
- Patients must have received previous treatment with aerosolized antibiotics without
demonstration of drug intolerance
- FEV1 ≤ 75% predicted at Visit 1
- Ability to perform reproducible pulmonary function tests
- Chest radiograph at Visit 1 without significant acute findings (eg, infiltrates
[lobar or diffuse interstitial], pleural effusion, pneumothorax); or chest radiograph
or MRI obtained within the 180 days prior to Visit 1 without acute findings and no
significant intercurrent illness; chronic, stable findings (eg, 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
- Inability to tolerate inhalation of a short acting beta agonist
- Changes in or initiation of chronic azithromycin treatment within 28 days prior to
Visit 1
- Administration of antipseudomonal antibiotics by inhalation, intravenous or oral
routes within the 14 days prior to Visit 1
- Changes in antimicrobial, bronchodilator (BD), dornase alfa, or corticosteroid
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 > 5 times upper limit of normal range (ULN)
- Creatinine > 2 times ULN
- Positive pregnancy test at Visit 1; all women of childbearing potential will be
tested
- Female of childbearing potential who is lactating or is not (in the opinion of the
investigator) practicing an acceptable method of birth control; female subjects who
utilize hormonal contraceptives as one of their birth control methods 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
Locations and Contacts
Crystal Green, Phone: 206.832.2092, Email: AZLI-CF@gilead.com
Salzburg A-5020, Austria; Not yet recruiting
Innsbruck A-6020, Austria; Not yet recruiting
Leuven 3000, Belgium; Recruiting
Antwerp 2650, Belgium; Recruiting
Bruxelles 1070, Belgium; Recruiting
Brussels 1090, Belgium; Recruiting
Ghent 9000, Belgium; Recruiting
Copenhagen DK-2100, Denmark; Recruiting
Bordeaux 33076, France; Recruiting
Caen 14000, France; Recruiting
Lisieux 14100, France; Recruiting
Nice cedex 3 06202, France; Recruiting
Paris Cedex 75743, France; Not yet recruiting
Montpellier 34295, France; Recruiting
Amiens 80054, France; Recruiting
Creteil 94000, France; Not yet recruiting
Rennes 35033, France; Not yet recruiting
Lille Cedex 59037, France; Not yet recruiting
Pessac Cedex 33604, France; Not yet recruiting
Mainz 55101, Germany; Withdrawn
Munchen 80336, Germany; Recruiting
Berlin 13125, Germany; Recruiting
Leipzig 04103, Germany; Recruiting
Essen 45239, Germany; Not yet recruiting
Essen 45122, Germany; Not yet recruiting
Hamburg 22763, Germany; Not yet recruiting
Berlin 12203, Germany; Not yet recruiting
Homburg 66421, Germany; Not yet recruiting
Bochum 44791, Germany; Not yet recruiting
Magdeburg 39120, Germany; Not yet recruiting
Dublin 24, Ireland; Not yet recruiting
Dublin 9, Ireland; Recruiting
Dublin 4, Ireland; Recruiting
Dublin, Ireland; Not yet recruiting
Galway, Ireland; Recruiting
Rome 00161, Italy; Recruiting
Verona 37126, Italy; Recruiting
Catania 95123, Italy; Recruiting
Rome 00165, Italy; Recruiting
Ancona 60123, Italy; Recruiting
Milano 20122, Italy; Not yet recruiting
Palermo 90134, Italy; Recruiting
Napoli 80131, Italy; Recruiting
Parma 43100, Italy; Not yet recruiting
Den Haag 2504 LN, Netherlands; Recruiting
Maastricht 6229, Netherlands; Recruiting
Rotterdam 3015 CD, Netherlands; Withdrawn
Rabka Zdroj 34-700, Poland; Not yet recruiting
Lodz 93-513, Poland; Not yet recruiting
Porto 4200 319, Portugal; Not yet recruiting
Lisboa 1649-035, Portugal; Not yet recruiting
Madrid 28009, Spain; Recruiting
Madrid 28034, Spain; Recruiting
Malaga 29011, Spain; Not yet recruiting
Madrid 28046, Spain; Recruiting
Madrid 28041, Spain; Not yet recruiting
Zuerich CH - 8091, Switzerland; Not yet recruiting
Zurich CH - 8032, Switzerland; Not yet recruiting
London SW3 6NP, United Kingdom; Recruiting
Cambridge CB23 3RE, United Kingdom; Recruiting
Southampton SO16 6YD, United Kingdom; Recruiting
Leeds LS9 7TF, United Kingdom; Not yet recruiting
Liverpool L14 3PE, United Kingdom; Recruiting
Belfast BT9 7AB, United Kingdom; Recruiting
Cardiff CF64-2XX, United Kingdom; Not yet recruiting
Anchorage, Alaska 99508, United States; Not yet recruiting
Tuscon, Arizona 85724, United States; Not yet recruiting
Orange, California 92868, United States; Recruiting
Aurora, Colorado 80045, United States; Not yet recruiting
Wilmington, Delaware 19803, United States; Not yet recruiting
Tampa, Florida 33606, United States; Not yet recruiting
Chicago, Illinois 60637, United States; Not yet recruiting
Columbia, Missouri 65212, United States; Not yet recruiting
Las Vegas, Nevada 89107, United States; Not yet recruiting
New Hyde Park, New York 11040, United States; Not yet recruiting
Dayton, Ohio 45404, United States; Not yet recruiting
Cincinnati, Ohio 45229, United States; Not yet recruiting
Oklahoma City, Oklahoma 73112, United States; Not yet recruiting
Hershey, Pennsylvania 17033, United States; Not yet recruiting
Philadelphia, Pennsylvania 19104, United States; Not yet recruiting
Charleston, South Carolina 29425, United States; Not yet recruiting
Houston, Texas 77030, United States; Not yet recruiting
San Antonio, Texas 78212, United States; Not yet recruiting
Salt Lake City, Utah 84132, United States; Not yet recruiting
Richmond, Virginia 23298, United States; Not yet recruiting
Sheffield, West Yorkshire S10 2TH, United Kingdom; Recruiting
Additional Information
Starting date: August 2008
Ending date: September 2010
Last updated: June 29, 2009
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