Aztreonam for Inhalation Solution vs Tobramycin Inhalation Solution in Patients With Cystic Fibrosis & Pseudomonas Aeruginosa
NCT ID: NCT00757237
Last Updated: 2011-07-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
274 participants
INTERVENTIONAL
2008-08-31
2010-11-30
Brief Summary
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Detailed Description
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Target Population: CF patients \>= 6 years of age with stable pulmonary disease, who at study entry had a recent positive sputum culture for PA and had been previously treated with aerosolized antibiotics without demonstration of drug intolerance.
The randomized phase of this study, used for hypotheses testing, enrolled participants from both the United States (US) and EU. An open-label, single-arm extension was available for participants in the EU who completed at least one course of AZLI or TIS during the randomized portion of the study. These participants were eligible to receive 3 additional cycles of AZLI in a 28-day, intermittent, repeating treatment regimen. Results of the extension phase will be available the first quarter (Q1) of 2012.
Randomized Phase Study Design (US and EU): This was an open-label, multicenter, randomized, parallel group study. The study design consisted of 2 treatment arms of 28-day, intermittent, repeating treatment regimens: aztreonam for inhalation solution (AZLI) or tobramycin inhalation solution (TIS). The total study period was 26 weeks. The study schedule included 9 visits - Screening, Baseline, Day 14, Day 28, followed by visits every 28 days through the end of the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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AZLI 75 mg 3 times a day (TID)
Aztreonam for Inhalation Solution (AZLI)
Aztreonam for inhalation solution (75 mg) was administered 3 times a day (TID) for 28 days for each treatment cycle via the PARI eFlow electronic nebulizer.
TIS 300 mg 2 times a day (BID)
Tobramycin Inhalation Solution (TIS)
Tobramycin inhalation solution (300 mg) was administered 2 times a day (BID) for 28 days for each treatment cycle via the PARI LC Plus nebulizer with compressor or via another nebulizer compatible with country-specified labeling.
Interventions
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Aztreonam for Inhalation Solution (AZLI)
Aztreonam for inhalation solution (75 mg) was administered 3 times a day (TID) for 28 days for each treatment cycle via the PARI eFlow electronic nebulizer.
Tobramycin Inhalation Solution (TIS)
Tobramycin inhalation solution (300 mg) was administered 2 times a day (BID) for 28 days for each treatment cycle via the PARI LC Plus nebulizer with compressor or via another nebulizer compatible with country-specified labeling.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects 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 2 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
* Subjects 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
* Subjects 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 magnetic resonance image (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
* 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 Randomization/Visit 2
* 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 aspartate aminotransferase (AST), alanine aminotransferase (ALT) \> 5 times upper limit of normal range (ULN) or 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
6 Years
ALL
No
Sponsors
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Chiltern International Inc.
INDUSTRY
ClinPhone, Inc.
INDUSTRY
Covance
INDUSTRY
Gilead Sciences
INDUSTRY
Responsible Party
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GSI
Principal Investigators
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Mark Bresnik, MD
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Anchorage, Alaska, United States
Phoenix, Arizona, United States
Tuscon, Arizona, United States
Orange, California, United States
Aurora, Colorado, United States
Denver, Colorado, United States
Wilmington, Delaware, United States
Orlando, Florida, United States
Tampa, Florida, United States
Chicago, Illinois, United States
Glenview, Illinois, United States
Niles, Illinois, United States
Boston, Massachusetts, United States
Columbia, Missouri, United States
Las Vegas, Nevada, United States
Albany, New York, United States
New Hyde Park, New York, United States
Cincinnati, Ohio, United States
Dayton, Ohio, United States
Toledo, Ohio, United States
Oklahoma City, Oklahoma, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Houston, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Richmond, Virginia, United States
Innsbruck, , Austria
Salzburg, , Austria
Antwerp, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Ghent, , Belgium
Leuven, , Belgium
Copenhagen, , Denmark
Amiens, , France
Bordeaux, , France
Caen, , France
Créteil, , France
Lille, , France
Lisieux, , France
Montpellier, , France
Nice, , France
Paris, , France
Pessac, , France
Rennes, , France
Berlin, , Germany
Berlin, , Germany
Bochum, , Germany
Essen, , Germany
Essen, , Germany
Giessen, , Germany
Hamburg, , Germany
Leipzig, , Germany
Magdeburg, , Germany
Mainz, , Germany
München, , Germany
Dublin, , Ireland
Dublin, , Ireland
Dublin, , Ireland
Dublin, , Ireland
Galway, , Ireland
Ancona, , Italy
Catania, , Italy
Milan, , Italy
Napoli, , Italy
Palermo, , Italy
Parma, , Italy
Rome, , Italy
Rome, , Italy
Verona, , Italy
Maastricht, , Netherlands
The Hague, , Netherlands
Lisbon, , Portugal
Porto, , Portugal
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Málaga, , Spain
Zurich, , Switzerland
Zurich, , Switzerland
Sheffield, West Yorkshire, United Kingdom
Belfast, , United Kingdom
Cambridge, , United Kingdom
Cardiff, , United Kingdom
Leeds, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
Southampton, , United Kingdom
Countries
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References
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Assael BM, Pressler T, Bilton D, Fayon M, Fischer R, Chiron R, LaRosa M, Knoop C, McElvaney N, Lewis SA, Bresnik M, Montgomery AB, Oermann CM; AZLI Active Comparator Study Group. Inhaled aztreonam lysine vs. inhaled tobramycin in cystic fibrosis: a comparative efficacy trial. J Cyst Fibros. 2013 Mar;12(2):130-40. doi: 10.1016/j.jcf.2012.07.006. Epub 2012 Sep 15.
Other Identifiers
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GS-US-205-0110
Identifier Type: -
Identifier Source: org_study_id