Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years
EARLY
A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. Aeruginosa in Cystic Fibrosis Subjects Aged From 3 Months to Less Than 7 Years
2 other identifiers
interventional
50
10 countries
19
Brief Summary
This study investigated the efficacy of inhaled TOBI treatment for early infections of P. aeruginosa in paediatric patients with cystic fibrosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2010
Longer than P75 for phase_3
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2010
CompletedFirst Posted
Study publicly available on registry
March 8, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
April 27, 2016
CompletedJuly 15, 2016
June 1, 2016
5.2 years
March 5, 2010
December 22, 2015
June 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants P Aeruginosa-free After Completion of the First Treatment Cycle
Sputum/throat swab cultures were assessed.
Day 29
Secondary Outcomes (2)
Percentage of Participants Free From P. Aeruginosa 28 Days After Termination of the Second Treatment Cycle
Day 91
Percentage of Participants P Aeruginosa-free at Termination of the Double Blind Period
Day 91
Study Arms (2)
TOBI (tobramycin inhaled solution)/Placebo
EXPERIMENTALParticipants 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).
Placebo/TOBI
PLACEBO COMPARATORParticipants 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).
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of cystic fibrosis
- Early lower respiratory tract infection with P. aeruginosa,
You may not qualify if:
- Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
- Administration of loop diuretics within 7 days prior to study drug administration.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Novartis Investigative Site
Toronto, Ontario, M5G 1X8, Canada
Novartis Investigative Site
Montreal, Quebec, H3T1C5, Canada
Novartis Investigative Site
Alexandria, 21131, Egypt
Novartis Investigative Site
Bordeaux, 33076, France
Novartis Investigative Site
Paris, 75019, France
Novartis Investigative Site
Dresden, 01307, Germany
Novartis Investigative Site
Pátrai, Greece, 265 00, Greece
Novartis Investigative Site
Thessaloniki, GR, 546 29, Greece
Novartis Investigative Site
Thessaloniki, GR, 546 42, Greece
Novartis Investigative Site
Debrecen, Hungary, 4032, Hungary
Novartis Investigative Site
Kaposvár, Hungary, 7400, Hungary
Novartis Investigative Site
Szeged, Hungary, 6725, Hungary
Novartis Investigative Site
Debrecen, 4043, Hungary
Novartis Investigative Site
Milan, MI, 20122, Italy
Novartis Investigative Site
Bucharest, 20395, Romania
Novartis Investigative Site
Kazan', 420012, Russia
Novartis Investigative Site
Voronezh, 394036, Russia
Novartis Investigative Site
Yaroslavl, 150003, Russia
Novartis Investigative Site
Zurich, Switzerland, 8032, Switzerland
Related Publications (1)
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.
PMID: 29685813DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2010
First Posted
March 8, 2010
Study Start
April 1, 2010
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
July 15, 2016
Results First Posted
April 27, 2016
Record last verified: 2016-06