Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years
NCT ID: NCT01082367
Last Updated: 2016-07-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
50 participants
INTERVENTIONAL
2010-04-30
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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TOBI (tobramycin inhaled solution)/Placebo
Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle).
TOBI
TOBI (tobramycin inhaled solution)
Placebo
Placebo
Placebo/TOBI
Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle).
TOBI
TOBI (tobramycin inhaled solution)
Placebo
Placebo
Interventions
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TOBI
TOBI (tobramycin inhaled solution)
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Early lower respiratory tract infection with P. aeruginosa,
Exclusion Criteria
* Administration of loop diuretics within 7 days prior to study drug administration.
3 Months
6 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Alexandria, , Egypt
Novartis Investigative Site
Bordeaux, , France
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Dresden, , Germany
Novartis Investigative Site
Pátrai, Greece, Greece
Novartis Investigative Site
Thessaloniki, GR, Greece
Novartis Investigative Site
Thessaloniki, GR, Greece
Novartis Investigative Site
Debrecen, Hungary, Hungary
Novartis Investigative Site
Kaposvár, Hungary, Hungary
Novartis Investigative Site
Szeged, Hungary, Hungary
Novartis Investigative Site
Debrecen, , Hungary
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Bucharest, , Romania
Novartis Investigative Site
Kazan', , Russia
Novartis Investigative Site
Voronezh, , Russia
Novartis Investigative Site
Yaroslavl, , Russia
Novartis Investigative Site
Zurich, Switzerland, Switzerland
Countries
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References
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Ratjen F, Moeller A, McKinney ML, Asherova I, Alon N, Maykut R, Angyalosi G; EARLY study group. Eradication of early P. aeruginosa infection in children <7 years of age with cystic fibrosis: The early study. J Cyst Fibros. 2019 Jan;18(1):78-85. doi: 10.1016/j.jcf.2018.04.002. Epub 2018 Apr 21.
Other Identifiers
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2009-016590-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CTBM100C2304
Identifier Type: -
Identifier Source: org_study_id
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